WorldWideScience

Sample records for good clinical research

  1. Pharmacokinetic studies of neuromuscular blocking agents: Good Clinical Research Practice (GCRP)

    DEFF Research Database (Denmark)

    Viby-Mogensen, J.; Østergaard, D.; Donati, F.

    2000-01-01

    Good Clinical Research Practice (GCRP), neuromuscular blocking agents, pharmacokinetics, pharmacokinetic/pharmacodynamic modeling, population pharmacokinetics, statistics, study design......Good Clinical Research Practice (GCRP), neuromuscular blocking agents, pharmacokinetics, pharmacokinetic/pharmacodynamic modeling, population pharmacokinetics, statistics, study design...

  2. RESEARCH Voluntary informed consent and good clinical practice ...

    African Journals Online (AJOL)

    of South Africa (1996) and applicable legislation, it is apparent that voluntary informed ... Seoul, 2008);4 Ethics in Health Research: Principles, Structures and. Processes (Department of Health 2004 – 'ethical guidelines' for the purpose of this ... workers have a legal duty to obtain a patient's informed consent for any medical ...

  3. Stem Cell Research and Clinical Translation: A Roadmap about Good Clinical Practice and Patient Care

    Directory of Open Access Journals (Sweden)

    Paola Frati

    2017-01-01

    Full Text Available The latest research achievements in the field of stem cells led in 2016 to the publication of “Guidelines for Stem Cell Research and Clinical Translation” by the International Society for Stem Cell Research (ISSCR. Updating the topics covered in previous publications, the new recommendations offer interesting ethical and scientific insights. Under the common principles of research integrity, protection of patient’s welfare, respect for the research subjects, transparency and social justice, the centrality of good clinical practice, and informed consent in research and translational medicine is supported. The guidelines implement the abovementioned publications, requiring rigor in all areas of research, promoting the validity of the scientific activity results and emphasizing the need for an accurate and efficient public communication. This paper aims to analyze the aforementioned guidelines in order to provide a valid interpretive tool for experts. In particular, a research activity focused on the bioethical, scientific, and social implications of the new recommendations is carried out in order to provide food for thought. Finally, as an emerging issue of potential impact of current guidelines, an overview on implications of compensation for egg donation is offered.

  4. The good laboratory practice and good clinical practice requirements for the production of radiopharmaceuticals in clinical research

    NARCIS (Netherlands)

    De Vos, FJ; De Decker, M; Dierckx, RA

    Radiopharmaceuticals account for more than 95% of the group of sterile pharmaceutical products and should therefore be handled and produced with care. Since the introduction of the European directive, all pharmaceuticals used in clinical studies must be prepared under good manufacturing practice

  5. 'Screening audit' as a quality assurance tool in good clinical practice compliant research environments.

    Science.gov (United States)

    Park, Sinyoung; Nam, Chung Mo; Park, Sejung; Noh, Yang Hee; Ahn, Cho Rong; Yu, Wan Sun; Kim, Bo Kyung; Kim, Seung Min; Kim, Jin Seok; Rha, Sun Young

    2018-04-25

    With the growing amount of clinical research, regulations and research ethics are becoming more stringent. This trend introduces a need for quality assurance measures for ensuring adherence to research ethics and human research protection beyond Institutional Review Board approval. Audits, one of the most effective tools for assessing quality assurance, are measures used to evaluate Good Clinical Practice (GCP) and protocol compliance in clinical research. However, they are laborious, time consuming, and require expertise. Therefore, we developed a simple auditing process (a screening audit) and evaluated its feasibility and effectiveness. The screening audit was developed using a routine audit checklist based on the Severance Hospital's Human Research Protection Program policies and procedures. The measure includes 20 questions, and results are summarized in five categories of audit findings. We analyzed 462 studies that were reviewed by the Severance Hospital Human Research Protection Center between 2013 and 2017. We retrospectively analyzed research characteristics, reply rate, audit findings, associated factors and post-screening audit compliance, etc. RESULTS: Investigator reply rates gradually increased, except for the first year (73% → 26% → 53% → 49% → 55%). The studies were graded as "critical," "major," "minor," and "not a finding" (11.9, 39.0, 42.9, and 6.3%, respectively), based on findings and number of deficiencies. The auditors' decisions showed fair agreement with weighted kappa values of 0.316, 0.339, and 0.373. Low-risk level studies, single center studies, and non-phase clinical research showed more prevalent frequencies of being "major" or "critical" (p = 0.002, audit grade (p audit results of post-screening audit compliance checks in "non-responding" and "critical" studies upon applying the screening audit. Our screening audit is a simple and effective way to assess overall GCP compliance by institutions and to

  6. Cost-effectiveness analysis alongside clinical trials II-An ISPOR Good Research Practices Task Force report.

    Science.gov (United States)

    Ramsey, Scott D; Willke, Richard J; Glick, Henry; Reed, Shelby D; Augustovski, Federico; Jonsson, Bengt; Briggs, Andrew; Sullivan, Sean D

    2015-03-01

    Clinical trials evaluating medicines, medical devices, and procedures now commonly assess the economic value of these interventions. The growing number of prospective clinical/economic trials reflects both widespread interest in economic information for new technologies and the regulatory and reimbursement requirements of many countries that now consider evidence of economic value along with clinical efficacy. As decision makers increasingly demand evidence of economic value for health care interventions, conducting high-quality economic analyses alongside clinical studies is desirable because they broaden the scope of information available on a particular intervention, and can efficiently provide timely information with high internal and, when designed and analyzed properly, reasonable external validity. In 2005, ISPOR published the Good Research Practices for Cost-Effectiveness Analysis Alongside Clinical Trials: The ISPOR RCT-CEA Task Force report. ISPOR initiated an update of the report in 2014 to include the methodological developments over the last 9 years. This report provides updated recommendations reflecting advances in several areas related to trial design, selecting data elements, database design and management, analysis, and reporting of results. Task force members note that trials should be designed to evaluate effectiveness (rather than efficacy) when possible, should include clinical outcome measures, and should obtain health resource use and health state utilities directly from study subjects. Collection of economic data should be fully integrated into the study. An incremental analysis should be conducted with an intention-to-treat approach, complemented by relevant subgroup analyses. Uncertainty should be characterized. Articles should adhere to established standards for reporting results of cost-effectiveness analyses. Economic studies alongside trials are complementary to other evaluations (e.g., modeling studies) as information for decision

  7. [Good clinical practices in clinical trials: the responsibility of the researcher. A survey of 827 hospital physicians (I). Availability. Monitoring. Safety. Contract].

    Science.gov (United States)

    Dal-Ré, R

    1993-03-06

    The Law of Medicaments establishes that clinical trials (CT) with drugs must be carried out following the of Good Clinical Practice guidelines (GCP). The attitude of hospital physicians to the GCP prior to its implementation as mandatory in accordance with Spanish legislation was considered to be of interest. An anonymous survey was used with closed response questions. Questions referring to the responsibilities of the investigator included in the GCP were included. From December 1988 to February 1990 the survey was distributed among 1,706 hospital medical staff members, of any specialty, who had or had not participated in CT. In this article the results of the questions regarding the availability of the investigative team, CT monitorization, management of adverse reactions, the safety of the participants in the CT and the contract between the sponsor and the researcher are presented. A total of 827 hospital doctors replied to the survey. Fifty-nine percent had intervened in CT with drugs. At least 94% of those surveyed considered that the researcher must have the time and number of eligible patients which the CT requires. There was high acceptance (> or = 78%) of the clinical audits to be performed by the health authorities and the sponsor company of the CT. The need of urgent communication of the severe adverse reactions is admitted by a great majority (> or = 95%) of those surveyed. Eighty-five percent believe that patients should be insured against damage derived from CT with 76% considering that the investigator should sign a contract with the sponsor; 68% and 59% would hand in a copy of the same to the CT committee and the remainder of the research team, respectively. According to the Good Clinical Practice dealt with in this article, the responsibilities of the investigator have been widely accepted by the hospital physicians surveyed, therefore no problems should be expected upon the implementation of the same in this country. However, the economic

  8. Clinical Outcome Assessments: Conceptual Foundation-Report of the ISPOR Clinical Outcomes Assessment - Emerging Good Practices for Outcomes Research Task Force.

    Science.gov (United States)

    Walton, Marc K; Powers, John H; Hobart, Jeremy; Patrick, Donald; Marquis, Patrick; Vamvakas, Spiros; Isaac, Maria; Molsen, Elizabeth; Cano, Stefan; Burke, Laurie B

    2015-09-01

    An outcome assessment, the patient assessment used in an endpoint, is the measuring instrument that provides a rating or score (categorical or continuous) that is intended to represent some aspect of the patient's health status. Outcome assessments are used to define efficacy endpoints when developing a therapy for a disease or condition. Most efficacy endpoints are based on specified clinical assessments of patients. When clinical assessments are used as clinical trial outcomes, they are called clinical outcome assessments (COAs). COAs include any assessment that may be influenced by human choices, judgment, or motivation. COAs must be well-defined and possess adequate measurement properties to demonstrate (directly or indirectly) the benefits of a treatment. In contrast, a biomarker assessment is one that is subject to little, if any, patient motivational or rater judgmental influence. This is the first of two reports by the ISPOR Clinical Outcomes Assessment - Emerging Good Practices for Outcomes Research Task Force. This report provides foundational definitions important for an understanding of COA measurement principles. The foundation provided in this report includes what it means to demonstrate a beneficial effect, how assessments of patients relate to the objective of showing a treatment's benefit, and how these assessments are used in clinical trial endpoints. In addition, this report describes intrinsic attributes of patient assessments and clinical trial factors that can affect the properties of the measurements. These factors should be considered when developing or refining assessments. These considerations will aid investigators designing trials in their choice of using an existing assessment or developing a new outcome assessment. Although the focus of this report is on the development of a new COA to define endpoints in a clinical trial, these principles may be applied more generally. A critical element in appraising or developing a COA is to

  9. Clinical Research

    DEFF Research Database (Denmark)

    Christensen, Irene

    2016-01-01

    This paper is about the logic of problem solving and the production of scientific knowledge through the utilisation of clinical research perspective. Ramp-up effectiveness, productivity, efficiency and organizational excellence are topics that continue to engage research and will continue doing so...... for years to come. This paper seeks to provide insights into ramp-up management studies through providing an agenda for conducting collaborative clinical research and extend this area by proposing how clinical research could be designed and executed in the Ramp- up management setting....

  10. Good research guide, second edition

    CSIR Research Space (South Africa)

    Scholes, RJ

    2003-01-01

    Full Text Available This guide informs CSIR staff about the standards that they are expected to meet when doing research. Researchers who follow this guide will have satisfied the legal requirement for 'due diligence' in their work....

  11. Principles of good regulatory research

    International Nuclear Information System (INIS)

    Rogers, K.

    1991-01-01

    The Commissioner of the US Regulatory Commission addresses several important research-related subjects. The paper describes the Agency philosophy with respect to independence, openness, efficiency, clarity, and reliability; research philosophy with respect to the need for research, the need for quality, and the need for efficiency; research areas with respect to plant aging, human factors, severe accident analysis, advanced reactors, and radioactive waste management; and systems approach to reactor operations, training, licensing, and maintenance

  12. Policy Research: Good or Bad?

    Directory of Open Access Journals (Sweden)

    Jerry P. White

    2013-07-01

    Full Text Available Canada went through a tough discussion in July 2013 when it was revealed that between 1942 and 1952 unethical and harmful research was conducted on Aboriginal peoples, most of whom were children. Beyond simply condemning unethical research with Indigenous populations, we need to examine why this happened and understand what the implications and lessons are for "policy research" moving forward. Policy research is a powerful tool when conducted in the proper way. We must never lose sight of the reason we are engaged in the activity: to improve well-being through the improvement of understanding that leads to change. The research process must, itself, be part of the positive process.

  13. Return on research investments: personal good versus public good

    Science.gov (United States)

    Fox, P. A.

    2017-12-01

    For some time the outputs, i.e. what's produced, of publicly and privately funded research while necessary, are far from sufficient, when considering an overall return on (research) investment. At the present time products such as peer-reviewed papers, websites, data, and software are recognized by funders on timescales related to research awards and reporting. However, from a consumer perspective impact and value are determined at the time a product is discovered, accessed, assessed and used. As is often the case, the perspectives of producer and consumer communities can be distinct and not intersect at all. We contrast personal good, i.e. credit, reputation, with that of public good, e.g. interest, leverage, exploitation, and more. This presentation will elaborate on both the metaphorical and idealogical aspects of applying a "return on investment" frame for the topic of assessing "good".

  14. The clinic as a good corporate neighbor.

    Science.gov (United States)

    Sass, Hans-Martin

    2013-02-01

    Clinics today specialize in health repair services similar to car repair shops; procedures and prices are standardized, regulated, and inflexibly uniform. Clinics of the future have to become Health Care Centers in order to be more respected and more effective corporate neighbors in offering outreach services in health education and preventive health care. The traditional concept of care for health is much broader than repair management and includes the promotion of lay health competence and responsibility in healthy social and natural environments. The corporate profile and ethics of the clinic as a good and competitive local neighbor will have to focus on [a] better personalized care, [b] education and services in preventive care, [c] direct or web-based information and advice for general, seasonal, or age related health risks, and on developing and improving trustworthy character traits of the clinic as a corporate person and a good neighbor.

  15. [What everybody should know about good clinical practices].

    Science.gov (United States)

    Osorio, Lyda

    2015-01-01

    An increasing number of countries are adopting good clinical practices guidelines as part of the regulation of clinical studies to register pharmaceutical products and other health-related products. Consequently, all parties involved in the research and development of these products should know them, implement them and ensure their compliance. However, good clinical practices guidelines are just one of the initiatives seeking to achieve the highest ethical and scientific standards in health research and in other areas where humans are research subjects. This review defines such practices and their objectives presenting in a practical manner their legal framework in Colombia, and clarifying their application in studies where interventions use no medications or those that are not clinical trials. Finally, the work discusses the challenges to ensure that good clinical practices contribute to the protection of research participants, the education of trustworthy health professionals, and a culture of respect for human beings.

  16. 77 FR 49449 - Food and Drug Administration Clinical Trial Requirements, Compliance, and Good Clinical Practice...

    Science.gov (United States)

    2012-08-16

    ... investigator initiated research. Topics for discussion include the following: (1) What FDA Expects in a...] Food and Drug Administration Clinical Trial Requirements, Compliance, and Good Clinical Practice...-sponsorship with the Society of Clinical Research Associates (SoCRA) is announcing a public workshop. The...

  17. HONESTY AND GOOD PRACTICE IN SCIENTIFIC RESEARCH

    Directory of Open Access Journals (Sweden)

    Jože Trontelj

    2008-01-01

    Full Text Available In the field of science, we see cases of misconduct ranging from relatively minor departurefrom good manners and practice to more severe dishonesty and even criminal behaviour.Unethical experiments on human beings are among the worst abuses in scientific researchin medicine. Unethical research is usually also worthless from the scientific point of view.The commonest types of offence, however, include mismanagement of data, conscious misinterpretation,wrongful authorship, biased citation of work by others, plagiarism, misquotationor suppression of findings for the interests or upon the request of the sponsor or In the field of science, we see cases of misconduct ranging from relatively minor departurefrom good manners and practice to more severe dishonesty and even criminal behaviour.Unethical experiments on human beings are among the worst abuses in scientific researchin medicine. Unethical research is usually also worthless from the scientific point of view.The commonest types of offence, however, include mismanagement of data, conscious misinterpretation,wrongful authorship, biased citation of work by others, plagiarism, misquotationor suppression of findings for the interests or upon the request of the sponsor or In the field of science, we see cases of misconduct ranging from relatively minor departurefrom good manners and practice to more severe dishonesty and even criminal behaviour.Unethical experiments on human beings are among the worst abuses in scientific researchin medicine. Unethical research is usually also worthless from the scientific point of view.The commonest types of offence, however, include mismanagement of data, conscious misinterpretation,wrongful authorship, biased citation of work by others, plagiarism, misquotationor suppression of findings for the interests or upon the request of the sponsor or even a senior scientist in the team. Every case of misconduct and fraud may causedamage: it may undermine confidence of the

  18. 76 FR 78933 - Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good...

    Science.gov (United States)

    2011-12-20

    ..., electronic record requirements, and investigator initiated research. Topics for discussion include the...] Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good Clinical... Clinical Research Associates (SoCRA), is announcing a public workshop. The public workshop on FDA's...

  19. The art of writing good research proposals.

    Science.gov (United States)

    van Ekelenburg, Henk

    2010-01-01

    Whilst scientists are by default motivated by intellectual challenges linked to the area of their interest rather than have an interest in the financial component related to their work, the reality of today is that funding for their work does not come automatically More and more governments provide project-related funding rather than multipurpose funding that covers the total annual costs of a research performing entity (such as a university department). So, like it or not, researchers have to present their research ideas and convince funding bodies about the usefulness and importance of their intended research work. Writing the research proposal is not simply typing words and punctuation. It requires succinctly and clearly chronicling the facts, as well as crafting a convincing line of reasoning for funding the project. For the best result, both the logical, verbal left side of the brain and the intuitive, creative right side of the brain need to work as a team. This article covers the process of writing a proposal, from research idea to submission to the funding body. The key to good writing is linking the text into a logical project flow. Therefore, in the early stage of writing an RTD proposal, developing the chain of reasoning and creating a flow chart is recommended to get a clear overview of the entire project and to visualise how the many work packages are connected.

  20. Prakriti-based research: Good reporting practices.

    Science.gov (United States)

    Bhalerao, Supriya; Patwardhan, Kishor

    2016-03-01

    The recent advances in the fields of genomics, personalized medicine, and Ayurveda have motivated many researchers to look at the relationship between Prakriti (phenotype-based Ayurveda constitution) and various objective biological parameters. As a result, a number of studies reporting such a relationship have made their way into mainstream scholarly journals. However, when it comes to the protocols that these workers follow to identify one's Prakriti, there are several issues that are yet to be resolved. In this communication, we propose a few reporting practices that such workers are required to be encouraged to follow, while submitting their work on Prakriti to scholarly journals. We have arranged this proposal under the following domains that may serve as a preliminary checklist in this context: The textual references, validation process, assessment of characters, scoring pattern, weightage assignment, criterion for expressing the final Prakriti type, and a need to publish the complete Prakriti-determination tool. We advocate that only if the workers in the field adhere to these good reporting practices, one will be able to draw meaningful, generalizable, and applicable interpretations out of such studies. We also suggest that the editors of relevant scholarly journals may recommend these reporting practices while considering such reports for publication. Copyright © 2016 Transdisciplinary University, Bangalore and World Ayurveda Foundation. Published by Elsevier B.V. All rights reserved.

  1. 76 FR 51040 - Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good...

    Science.gov (United States)

    2011-08-17

    ... requirements, and investigator initiated research. Topics for discussion include the following: (1) What FDA...] Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good Clinical... Clinical Research Associates (SoCRA) is announcing a public workshop. The public workshop on FDA's clinical...

  2. At the United Nation Foundation's Social Good Summit, Vice President Biden Announces New Cancer Moonshot International Cooperation and Investments | Office of Cancer Clinical Proteomics Research

    Science.gov (United States)

    This week, Vice President Joe Biden announced progress on his global vision for the Cancer Moonshot.  Announced were 10 new Memoranda of Understanding or Memoranda of Cooperation for international cancer research and care, as well as new efforts in the emerging scientific areas of precision oncology, the funding of collaborative research centers to address cancer disparities in low- and middle- income (LMIC) countries, and a strengthening of existing U.S. bilateral science and technology engagements around cancer.  

  3. Research Areas - Clinical Trials

    Science.gov (United States)

    Information about NCI programs and initiatives that sponsor, conduct, develop, or support clinical trials, including NCI’s Clinical Trial Network (NCTN) and NCI Community Oncology Research Program (NCORP) initiatives.

  4. Clinical research informatics

    CERN Document Server

    Richesson, Rachel L

    2012-01-01

    This book provides foundational coverage of key areas, concepts, constructs, and approaches of medical informatics as it applies to clinical research activities, in both current settings and in light of emerging policies. The field of clinical research is fully characterized (in terms of study design and overarching business processes), and there is emphasis on information management aspects and informatics implications (including needed activities) within various clinical research environments. The purpose of the book is to provide an overview of clinical research (types), activities, and are

  5. 75 FR 14448 - Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good...

    Science.gov (United States)

    2010-03-25

    ... requirements, and investigator initiated research. Topics for discussion include the following: (1) What FDA...] Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good Clinical... Society of Clinical Research Associates, Inc. (SoCRA) is announcing a public workshop entitled ``FDA...

  6. 77 FR 8886 - Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good...

    Science.gov (United States)

    2012-02-15

    ..., electronic record requirements, and investigator initiated research. Topics for discussion include the...] Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good Clinical... Research Associates (SoCRA) is announcing a public workshop. The public workshop on FDA's clinical trial...

  7. Clinical audit: Development of the criteria of good practices

    International Nuclear Information System (INIS)

    Soimakallio, S.; Alanen, A.; Jaervinen, H.; Ahonen, A.; Ceder, K.; Lyyra-Laitinen, T.; Paunio, M.; Sinervo, T.; Wigren, T.

    2011-01-01

    Clinical audit is a systematic review of the procedures in order to improve the quality and the outcome of patient care, whereby the procedures are examined against agreed standards for good medical Radiological procedures. The criteria of good procedures (i.e. the good practice) are thus the cornerstones for development of clinical audits: these should be the basis of assessments regardless of the type of the audit-external, internal, comprehensive or partial. A lot of criteria for good practices are available through the recommendations and publications by international and national professional societies and other relevant organisations. For practical use in clinical audits, the criteria need to be compiled, sorted out and agreed on for the particular aims of an audit (comprehensive or partial, external or internal). The national professional and scientific societies can provide valuable contribution to this development. For examination-or treatment-specific criteria- preliminary consensus needs to be obtained with the help of clinical experts, while clinical audits can be useful as a benchmarking tool to improve the criteria. (authors)

  8. Rules for the certification of good practices in clinical laboratories. No regulation. 3-2009. Good Laboratory Practice

    International Nuclear Information System (INIS)

    2015-01-01

    Regulation for Certification of Good Practices in clinical laboratories, hereinafter Regulation establishes the methodology and procedures for clinical laboratories to demonstrate their state of compliance with good practices, according to Regulation 3-2009, and that the CECMED can verify.

  9. Educating for Good Work: From Research to Practice

    Science.gov (United States)

    Mucinskas, Daniel; Gardner, Howard

    2013-01-01

    Launched in 1995, the GoodWork Project is a long-term, multi-site effort to understand the nature of good work across the professional landscape and to promote its achievement by relevant groups of students and professionals. In this essay, the authors review the goals and methods of the initial research project and its most salient findings. They…

  10. How to…write a good research question

    NARCIS (Netherlands)

    Mattick, Karen; Johnston, Jenny; de la Croix, Anne

    This paper, on writing research questions, is the first in a series that aims to support novice researchers within clinical education, particularly those undertaking their first qualitative study. Put simply, a research question is a question that a research project sets out to answer. Most research

  11. Good science, bad science: Questioning research practices in psychological research

    NARCIS (Netherlands)

    Bakker, M.

    2014-01-01

    In this dissertation we have questioned the current research practices in psychological science and thereby contributed to the current discussion about the credibility of psychological research. We specially focused on the problems with the reporting of statistical results and showed that reporting

  12. Clinical Research and Clinical Trials

    Science.gov (United States)

    ... Research Information Find a Study Resources and Publications HIV/AIDS Condition Information NICHD Research Information Find a ... Videos Get to Know NICHD Podcasts and Audio Social Media Join ... aims to advance medical knowledge by studying people, either through direct interaction or through the collection and analysis of blood, ...

  13. Research ethics for clinical researchers.

    Science.gov (United States)

    Harnett, John D; Neuman, Richard

    2015-01-01

    This chapter describes the history of the development of modern research ethics. The governance of research ethics is discussed and varies according to geographical location. However, the guidelines used for research ethics review are very similar across a wide variety of jurisdictions. The paramount importance of protecting the privacy and confidentiality of research participants is discussed at length. Particular emphasis is placed on the process of informed consent, and step-by-step practical guidelines are described. The issue of research in vulnerable populations is touched upon and guidelines are provided. Practical advice is provided for researchers to guide their interactions with research ethics boards. Issues related to scientific misconduct and research fraud are not dealt with in this paper.

  14. Political Science: Witchcraft or Craftsmanship? Standards for Good Research

    DEFF Research Database (Denmark)

    Nørgaard, Asbjørn Sonne

    2008-01-01

    Scientific debate requires a common understanding of what constitutes good research. The purpose of this article is to establish such an understanding. The purpose of political science is to uncover, understand and explain the conformist aspect of social behavior, well aware that not all behavior...... is systematically determined by society. Good political science ought to be grounded in two questions: What do we know, and what are we going to learn? Research question and theory are decisive, while all discussion about methodology and design is about subjecting our prejudices and expectations to the most...

  15. ["Good dying"--definition and current state of research].

    Science.gov (United States)

    Hutter, Nico; Stößel, Ulrich; Meffert, Cornelia; Körner, Mirjam; Bozzaro, Claudia; Becker, Gerhild; Baumeister, Harald

    2015-08-01

    The advances of modern medicine did not only result in prolongation of life expectancy, but also led to a shift from dying at home to dying in public institutions. In western countries most people die at advanced age in medical facilities. Hence, the question regarding the conditions, which should be provided by society and especially medicine, to allow terminally ill people to experience "good dying" is substantial. For this purpose, an examination of patients', family members' and health care providers' understanding of the term " good dying" is required. The present paper aims at shedding light on the term "good dying" and to summarize the current state of research. Therefore, the attributes of "good dying" will be described from the perspectives of patients, family members and health care providers, which are discussed and examined in current medical-sociological research. These attributes can be illustrated on three dimensions: Quality of life at the end of life (e. g. pain relief, mental well-being), quality of dying (e. g. avoiding prolonged dying, autonomy, presence of relatives) and quality of health care at the end of life (e. g. patient-oriented health care, positive communication between health care providers and patients, availability of guidelines). Although the attributes of "good dying" are described in detail in the existing literature, further studies have to clarify the relevance and impact of these attributes as predictors of "good dying". © Georg Thieme Verlag KG Stuttgart · New York.

  16. [Identifying indicators of good practice in clinical and healthcare management].

    Science.gov (United States)

    Bermúdez Tamayo, C; Olry de Labry Lima, A; García Mochón, L

    2018-03-06

    To identify good practices in order to develop and implement indicators of health outcomes for clinical and healthcare management, as well as the characteristics for an indicator to be considered adequate. A scoping review was performed, with the following phases: 1) Search and identification of bibliography. 2) Selection of relevant documents. Including those studies that discussed issues related to good practices for the use of health indicators in the management field. Those published in a language other than English or Spanish or before 2006 were excluded. 3) Analysis and extraction of information. 4) Consultation with stakeholders, using a qualitative methodology through Concept Mapping, with the participation of 40 experts (decision-makers, scientific societies, and health professionals). The data collection process included an inductive and structured procedure, with prioritisation of ideas grouped into clusters, according to feasibility and importance criteria (0-10 scale). Good practices identified 2 levels: 1) macro-management: Define a framework for the evaluation of indicators and establish a benchmark of indicators. 2) meso-management: Establish indicators according to evidence and expert consensus, taking into account priority areas and topics, testing before final use, and communicate results adequately. The characteristics of a suitable indicator are: 1) Approach of an important issue, 2) Scientific validity, 3) Possibility of measurement with reliable data, 4) Meaning of useful and applicable measurement, and 5) Wide scope. The best practices for the use of indicators in clinical and healthcare management can make it easier to monitor performance and accountability, as well as to support the decision-making addressed at the development of initiatives for quality improvement. Copyright © 2018 SECA. Publicado por Elsevier España, S.L.U. All rights reserved.

  17. Good Practice and Recommendations for Research Team Leadership

    Science.gov (United States)

    2017-05-01

    which makes the junior researcher receptive to branching out. Again, one avenue that facilitates expanding their skill set is the assignment detail...bit of “flavor” can be added by sharing with the audience any surprises, difficulties, or lessons learned along the way. A good team leader should

  18. TWO CRITERIA FOR GOOD MEASUREMENTS IN RESEARCH: VALIDITY AND RELIABILITY

    Directory of Open Access Journals (Sweden)

    Haradhan Kumar Mohajan

    2017-12-01

    Full Text Available Reliability and validity are two most important and fundamental features in the evaluation of any measurement instrument or toll for a good research. The purpose of this research is to discuss the validity and reliability of measurement instruments that are used in research. Validity concerns what an instrument measures, and how well it does so. Reliability concerns the faith that one can have in the data obtained from use of an instrument, that is, the degree to which any measuring tool controls for random error. An attempt has been taken here to review the reliability and validity, and threat to them in some details.

  19. Good and Bad Research Collaborations: Researchers' Views on Science and Ethics in Global Health Research.

    Directory of Open Access Journals (Sweden)

    Michael Parker

    Full Text Available There has been a dramatic rise in the scale and scope of collaborative global health research. A number of structural and scientific factors explain this growth and there has been much discussion of these in the literature. Little, if any, attention has been paid, however, to the factors identified by scientists and other research actors as important to successful research collaboration. This is surprising given that their decisions are likely to play a key role in the sustainability and effectiveness of global health research initiatives. In this paper, we report on qualitative research with leading scientists involved in major international research collaborations about their views on good and bad collaborations and the factors that inform their decision-making about joining and participating actively in research networks. We identify and discuss eight factors that researchers see as essential in judging the merits of active participation in global health research collaborations: opportunities for active involvement in cutting-edge, interesting science; effective leadership; competence of potential partners in and commitment to good scientific practice; capacity building; respect for the needs, interests and agendas of partners; opportunities for discussion and disagreement; trust and confidence; and, justice and fairness in collaboration. Our findings suggest that the sustainability and effectiveness of global health research collaborations has an important ethical or moral dimension for the research actors involved.

  20. Good and Bad Research Collaborations: Researchers' Views on Science and Ethics in Global Health Research.

    Science.gov (United States)

    Parker, Michael; Kingori, Patricia

    2016-01-01

    There has been a dramatic rise in the scale and scope of collaborative global health research. A number of structural and scientific factors explain this growth and there has been much discussion of these in the literature. Little, if any, attention has been paid, however, to the factors identified by scientists and other research actors as important to successful research collaboration. This is surprising given that their decisions are likely to play a key role in the sustainability and effectiveness of global health research initiatives. In this paper, we report on qualitative research with leading scientists involved in major international research collaborations about their views on good and bad collaborations and the factors that inform their decision-making about joining and participating actively in research networks. We identify and discuss eight factors that researchers see as essential in judging the merits of active participation in global health research collaborations: opportunities for active involvement in cutting-edge, interesting science; effective leadership; competence of potential partners in and commitment to good scientific practice; capacity building; respect for the needs, interests and agendas of partners; opportunities for discussion and disagreement; trust and confidence; and, justice and fairness in collaboration. Our findings suggest that the sustainability and effectiveness of global health research collaborations has an important ethical or moral dimension for the research actors involved.

  1. KNOWLEDGE FROM RESEARCH AS A QUASI-PUBLIC GOOD

    Directory of Open Access Journals (Sweden)

    Attila György

    2011-06-01

    Full Text Available Knowledge is a special quasi-public good which is delivered by several types of institutions, including public and private universities. Knowledge to be produced in bigger quantities, the state should contribute with budgetary financial support as subsidies or grants to cover a part of expenses. States are supporting research from public resources, especially the basic research which enjoy a smaller interest from the private research units due its small potential to be implemented and recovered throughout price. Public co-founding of research generates problems regarding the regime of patents’ ownership because financing bodies have divergent opinion regarding the utility of research in society’s development. There are different approaches offered in solving this problem, taking into account the forms of realizing this quasi-public good, approaches based especially on different type of joint-ventures. Academic research, perceived as a very important and income generating activity, is done in a very large scale of combinations between universities and private entities. These complicated relations generates information asymmetry specific to principal-agent relations in economy. The control of information asymmetry level is important because a high level corresponds to inefficient use of funds and smaller satisfaction of general needs.

  2. 77 FR 49448 - Food and Drug Administration Clinical Trial Requirements, Compliance, and Good Clinical Practice...

    Science.gov (United States)

    2012-08-16

    ... include the following: (1) Are We There Yet?; (2) What FDA Expects in a Pharmaceutical Clinical Trial; (3) Medical Device Aspects of Clinical Research; (4) Adverse Event Reporting--Science, Regulation, Error, and...

  3. Research leadership: should clinical directors be distinguished researchers?

    Science.gov (United States)

    Allison, Stephen; Goodall, Amanda H; Bastiampillai, Tarun

    2016-06-01

    Clinical directors established research-led healthcare by combining research, teaching and clinical excellence within the teaching hospitals. This research culture created high clinical standards, which benefited patients, the workforce and healthcare organisations. The current paper explores this research leadership role for clinical directors. It reviews studies arising from the theory of expert leadership, which focuses on the relationship between a leader's core knowledge and organisational performance. More specifically, we examine the expert leader's research track record, the associations with their organisation's performance, and the influence of research activity on clinical excellence. Distinguished researchers still lead the most prestigious teaching hospitals and the most trusted departments of psychiatry in the United States where the clinical directorate structure originated. It is also known that good scholars can improve research output when appointed to leadership positions. This suggests that the clinical director's research track record should be a consideration at a time when research is being embedded in Australia's local health networks. A clinical director's leadership may influence the research performance of their department and contribute to the quality of mental healthcare. © The Royal Australian and New Zealand College of Psychiatrists 2015.

  4. Sponsorship in non-commercial clinical trials: definitions, challenges and the role of Good Clinical Practices guidelines.

    Science.gov (United States)

    Ravinetto, Raffaella; De Nys, Katelijne; Boelaert, Marleen; Diro, Ermias; Meintjes, Graeme; Adoke, Yeka; Tagbor, Harry; Casteels, Minne

    2015-12-30

    Non-commercial clinical research plays an increasingly essential role for global health. Multiple partners join in international consortia that operate under the limited timeframe of a specific funding period. One organisation (the sponsor) designs and carries out the trial in collaboration with research partners, and is ultimately responsible for the trial's scientific, ethical, regulatory and legal aspects, while another organization, generally in the North (the funder), provides the external funding and sets funding conditions. Even if external funding mechanisms are key for most non-commercial research, the dependence on an external funder's policies may heavily influence the choices of a sponsor. In addition, the competition for accessing the available external funds is great, and non-commercial sponsors may not be in a position to discuss or refuse standard conditions set by a funder. To see whether the current definitions adequately address the intricacies of sponsorship in externally-funded trials, we looked at how a "sponsor" of clinical trials is defined in selected international guidelines, with particular focus on international Good Clinical Practices codes, and in selected European and African regulations/legislations. Our limited analysis suggests that the sponsors definition from the 1995 WHO Good Clinical Practices code has been integrated as such into many legislations, guidelines and regulations, and that it is not adequate to cover today's reality of funding arrangements in global health, where the legal responsibility and the funding source are de facto split. In agreement with other groups, we suggest that the international Good Clinical Practices codes should be updated to reflect the reality of non-commercial clinical research. In particular, they should explicitly include the distinction between commercial and non-commercial sponsors, and provide guidance to non-commercial sponsors for negotiating with external funding agencies and other

  5. Seeing is believing: good graphic design principles for medical research.

    Science.gov (United States)

    Duke, Susan P; Bancken, Fabrice; Crowe, Brenda; Soukup, Mat; Botsis, Taxiarchis; Forshee, Richard

    2015-09-30

    Have you noticed when you browse a book, journal, study report, or product label how your eye is drawn to figures more than to words and tables? Statistical graphs are powerful ways to transparently and succinctly communicate the key points of medical research. Furthermore, the graphic design itself adds to the clarity of the messages in the data. The goal of this paper is to provide a mechanism for selecting the appropriate graph to thoughtfully construct quality deliverables using good graphic design principles. Examples are motivated by the efforts of a Safety Graphics Working Group that consisted of scientists from the pharmaceutical industry, Food and Drug Administration, and academic institutions. Copyright © 2015 John Wiley & Sons, Ltd.

  6. SPECIAL ARTICLE Clinical research

    African Journals Online (AJOL)

    tal and practical work done in the best laboratories'.' I have previously argued that the components of aca- ... whom he admired, said 'Sydenham was called "a man of many doubts" and therein lay the secret of his .... It is worthwhile remembering, young researcher, that the probability or 'P' value is only a statement of the.

  7. Promoting Good Clinical Laboratory Practices and Laboratory Accreditation to Support Clinical Trials in Sub-Saharan Africa

    Science.gov (United States)

    Shott, Joseph P.; Saye, Renion; Diakité, Moussa L.; Sanogo, Sintry; Dembele, Moussa B.; Keita, Sekouba; Nagel, Mary C.; Ellis, Ruth D.; Aebig, Joan A.; Diallo, Dapa A.; Doumbo, Ogobara K.

    2012-01-01

    Laboratory capacity in the developing world frequently lacks quality management systems (QMS) such as good clinical laboratory practices, proper safety precautions, and adequate facilities; impacting the ability to conduct biomedical research where it is needed most. As the regulatory climate changes globally, higher quality laboratory support is needed to protect study volunteers and to accurately assess biological parameters. The University of Bamako and its partners have undertaken a comprehensive QMS plan to improve quality and productivity using the Clinical and Laboratory Standards Institute standards and guidelines. The clinical laboratory passed the College of American Pathologists inspection in April 2010, and received full accreditation in June 2010. Our efforts to implement high-quality standards have been valuable for evaluating safety and immunogenicity of malaria vaccine candidates in Mali. Other disease-specific research groups in resource-limited settings may benefit by incorporating similar training initiatives, QMS methods, and continual improvement practices to ensure best practices. PMID:22492138

  8. What is a Good Piece of Information Systems Research

    DEFF Research Database (Denmark)

    Vendelø, Morten Thanning

    2004-01-01

    Keywords: Epistemology, field formation, information systems research, paradigms, research fields.......Keywords: Epistemology, field formation, information systems research, paradigms, research fields....

  9. Research on Design Information Management System for Leather Goods

    Science.gov (United States)

    Lu, Lei; Peng, Wen-li

    The idea of setting up a design information management system of leather goods was put forward to solve the problems existed in current information management of leather goods. Working principles of the design information management system for leather goods were analyzed in detail. Firstly, the acquiring approach of design information of leather goods was introduced. Secondly, the processing methods of design information were introduced. Thirdly, the management of design information in database was studied. Finally, the application of the system was discussed by taking the shoes products as an example.

  10. Good Practice for Introducing Radiopharmaceuticals for Clinical Use

    International Nuclear Information System (INIS)

    2016-02-01

    The use of new radiopharmaceuticals can provide extremely valuable information in the evaluation of cancer, as well as heart and brain diseases. Information that often times cannot be obtained by other means. However, there is a perceived need in many Member States for a useful reference to facilitate and expedite the introduction of radiopharmaceuticals already in clinical use in other countries. This publication intends to provide practical support for the introduction of new radiotracers, including recommendations on the necessary steps needed to facilitate and expedite the introduction of radiopharmaceuticals in clinical use, while ensuring that a safe and high quality product is administered to the patient at all times

  11. Promoting good health research practice in low- and middle-income countries.

    Science.gov (United States)

    Mahendradhata, Yodi; Nabieva, Jamila; Ahmad, Riris Andono; Henley, Patricia; Launois, Pascal; Merle, Corinne; Maure, Christine; Horstick, Olaf; Elango, Varalakshmi

    2016-01-01

    Good clinical practice (GCP) guidelines have been the source of improvement in the quality of clinical trials; however, there are limitations to the application of GCP in the conduct of health research beyond industry-sponsored clinical trials. The UNICEF/UNDP/World Bank/WHO Special Program for Research and Training in Tropical Disease is promoting good practice in all health research involving human through the Good Health Research Practice (GHRP) training program initiative. To report the results of piloting the GHRP training program and formulate further steps to harness GHRP for promoting good practices in all health research involving human, particularly in low- and middle-income countries (LMICs). The objective of this training is to impart knowledge and skills for the application of ethical and quality principles to the design, conduct, recording, and reporting of health research involving human participants based on the level of risk, to ensure a fit-for-purpose quality system. This has been formulated into five sequential modules to be delivered in a 4-day course. Four courses have been organized in the pilot phase (2014-2015). The courses have been evaluated and assessed based on course feedback (quantitative and qualitative data) collected during course implementation and qualitative email-based pre- and post-course evaluation. Participants were highly satisfied with the course content and its organization. The relevance and applicability of the course content resulted in positive feedback and an articulated willingness to adapt and disseminate the course. Action points to strengthen the training program have been identified, and showed the imminent need to develop a consensus with a broader range of key stakeholders on the final set of GHRP standards and means for implementation. There is an urgent need to harness the momentum to promote high-quality and ethical health research in LMICs through scaling up GHRP training and further development of GHRP

  12. Promoting good health research practice in low- and middle-income countries

    Directory of Open Access Journals (Sweden)

    Yodi Mahendradhata

    2016-08-01

    Full Text Available Background: Good clinical practice (GCP guidelines have been the source of improvement in the quality of clinical trials; however, there are limitations to the application of GCP in the conduct of health research beyond industry-sponsored clinical trials. The UNICEF/UNDP/World Bank/WHO Special Program for Research and Training in Tropical Disease is promoting good practice in all health research involving human through the Good Health Research Practice (GHRP training program initiative. Objective: To report the results of piloting the GHRP training program and formulate further steps to harness GHRP for promoting good practices in all health research involving human, particularly in low- and middle-income countries (LMICs. Design: The objective of this training is to impart knowledge and skills for the application of ethical and quality principles to the design, conduct, recording, and reporting of health research involving human participants based on the level of risk, to ensure a fit-for-purpose quality system. This has been formulated into five sequential modules to be delivered in a 4-day course. Four courses have been organized in the pilot phase (2014–2015. The courses have been evaluated and assessed based on course feedback (quantitative and qualitative data collected during course implementation and qualitative email-based pre- and post-course evaluation. Results: Participants were highly satisfied with the course content and its organization. The relevance and applicability of the course content resulted in positive feedback and an articulated willingness to adapt and disseminate the course. Action points to strengthen the training program have been identified, and showed the imminent need to develop a consensus with a broader range of key stakeholders on the final set of GHRP standards and means for implementation. Conclusions: There is an urgent need to harness the momentum to promote high-quality and ethical health research in

  13. Research on Effective Supply Mode of Rural Public Goods

    Institute of Scientific and Technical Information of China (English)

    2011-01-01

    On the basis of definition and classification of rural public goods, this paper analyses the status quo of public goods supply in vast rural areas of China, and it indicates that the electricity and communication facility in rural areas have not yet been popularized; the culture and education facility is critically backward; the medical care and social warfare institutions are short. It points out the rational supply model of public goods as follows: the government plays dominant role in the public goods supply with a large amount of investments, related to the quality of living and production of multitudinous farmers; small wieldy quasi-public goods that can be easily supplied and marginalized public goods can introduce multiplex supply main body under the framework of government guidance. According to this model, corresponding policy suggestions are put forward as follows: increase financial inputs, and perfect local financial system; actively encourage the majority of farmers in rural areas to participate in public goods supply mechanism, so that the supply has pertinence; vigorously develop multiplex supply system of rural public goods, to ensure effective supply.

  14. Research on Goods and the Ship Interaction Based on ADAMS

    Directory of Open Access Journals (Sweden)

    Song Fangzhen

    2017-01-01

    Full Text Available The equivalent method of the relative movement goods on board is discussed in details. This method is to establish dynamic model based on moving trajectory of gravity-center for goods and to take rigid body geometric model with the trajectory as constraints in ADAMS. The difference of simulation methods for the different goods in carrier rolling is compared. The interact of relative moving objects with bulk carrier is discussed by using the ADAMS model. It is verified that the ballast water can maintain the ship’s stability by means of the ADAMS model.

  15. Good clinical practice regulatory inspections: Lessons for Indian investigator sites

    Directory of Open Access Journals (Sweden)

    R Marwah

    2010-01-01

    Full Text Available Regulatory inspections are important to evaluate the integrity of the data submitted to health authorities (HAs, protect patient safety, and assess adequacy of site/sponsor quality systems to achieve the same. Inspections generally occur after submission of data for marketing approval of an investigational drug. In recent years, there has been a significant increase in number of inspections by different HAs, including in India. The assessors/inspectors generally do a thorough review of site data before inspections. All aspects of ICH-GCP, site infrastructure, and quality control systems are assessed during the inspection. Findings are discussed during the close out meeting and a detailed inspection report issued afterward, which has to be responded to within 15-30 days with effective Corrective and Preventive Action Plan (CAPA. Protocol noncompliance, inadequate/inaccurate records, inadequate drug accountability, informed consent issues, and adverse event reporting were some of the most common findings observed during recent Food and Drug Administration (FDA inspections. Drug development is being increasingly globalized and an increased number of patients enrolled in studies submitted as part of applications come from all over the world including India. Because of the steep increase in research activity in the country, inexperienced sites, and more stakeholders, increased efforts will be required to ensure continuous quality and compliance. HAs have also made clear that enforcement will be increased and be swift, aggressive, and effective.

  16. Good practice in educational research : An outline using four paradigms

    OpenAIRE

    J.E., King

    2006-01-01

    This article employs four different research papers (a case study, an action research project, an ethnography and a quantitative nomothetic study) to illustrate some of the basic concepts which make up sound educational research. Issues such as research design, sampling, data collection, data analysis and validity are all discussed. Particular emphasis is placed in the paper on the need for transparency on the part of researchers when presenting their findings.

  17. Managing and sharing research data a guide to good practice

    CERN Document Server

    Corti, Louise; Bishop, Libby; Woollard, Matthew

    2014-01-01

    Research funders in the UK, USA and across Europe are implementing data management and sharing policies to maximize openness of data, transparency and accountability of the research they support. Written by experts from the UK Data Archive with over 20 years experience, this book gives post-graduate students, researchers and research support staff the data management skills required in today’s changing research environment.

  18. Good questions require good answers. Critics on current climate research contradicted

    International Nuclear Information System (INIS)

    Vellinga, P.; Van Dorland, R.; Kabat, P.

    2008-01-01

    In some of the previous issues of this magazine (Spil 2007, issue 4 and 5-6, and Spil 2008, issue 1) the authors Labohm, Roersch and Thoenes started a frontal attack of the greenhouse theory and the researchers who report on the state of science in the framework of the IPCC. The author of this article addresses two main questions arising from the above-mentioned authors: (1) Does the use of fossil fuels affect global climate?; and (2) Is the warming of the last 30 years related to the increasing concentrations of greenhouse gases in the atmosphere? [mk] [nl

  19. [Research activity in clinical biochemistry

    DEFF Research Database (Denmark)

    Jorgensen, H.L.; Larsen, B.; Ingwersen, P.

    2008-01-01

    Clinical Biochemistry, 57 fulfilled the inclusion criteria. Each of these 57 was matched according to medical title with two randomly chosen specialists from other specialities, totaling 114. Using Medline and the Web of Science, the number of publications and the number of citations were then ascertained......BACKGROUND: Quantitative bibliometric measurements of research activity are frequently used, e.g. for evaluating applicants for academic positions. The purpose of this investigation is to assess research activity within the medical speciality of Clinical Biochemistry by comparing it with a matched....... RESULTS: 25% of the 11,691 specialists held a PhD degree or doctoral degree, DMSci, (Clinical Biochemistry: 61%). The 171 specialists included in the study had 9,823 papers in Medline and 10,140 papers in the Web of Science. The number of Medline papers per specialist was 71 for Clinical Biochemistry...

  20. [Research activity in clinical biochemistry

    DEFF Research Database (Denmark)

    Jorgensen, H.L.; Larsen, B.; Ingwersen, P.

    2008-01-01

    BACKGROUND: Quantitative bibliometric measurements of research activity are frequently used, e.g. for evaluating applicants for academic positions. The purpose of this investigation is to assess research activity within the medical speciality of Clinical Biochemistry by comparing it with a matched...... Clinical Biochemistry, 57 fulfilled the inclusion criteria. Each of these 57 was matched according to medical title with two randomly chosen specialists from other specialities, totaling 114. Using Medline and the Web of Science, the number of publications and the number of citations were then ascertained....... RESULTS: 25% of the 11,691 specialists held a PhD degree or doctoral degree, DMSci, (Clinical Biochemistry: 61%). The 171 specialists included in the study had 9,823 papers in Medline and 10,140 papers in the Web of Science. The number of Medline papers per specialist was 71 for Clinical Biochemistry...

  1. Visual research in clinical education.

    Science.gov (United States)

    Bezemer, Jeff

    2017-01-01

    The aim of this paper is to explore what might be gained from collecting and analysing visual data, such as photographs, scans, drawings, video and screen recordings, in clinical educational research. Its focus is on visual research that looks at teaching and learning 'as it naturally occurs' in the work place, in simulation centres and other sites, and also involves the collection and analysis of visual learning materials circulating in these sites. With the ubiquity of digital recording devices, video data and visual learning materials are now relatively cheap to collect. Compared to other domains of education research visual materials are not widely used in clinical education research. The paper sets out to identify and reflect on the possibilities for visual research using examples from an ethnographic study on surgical and inter-professional learning in the operating theatres of a London hospital. The paper shows how visual research enables recognition, analysis and critical evaluation of (1) the hidden curriculum, such as the meanings implied by embodied, visible actions of clinicians; (2) the ways in which clinical teachers design multimodal learning environments using a range of modes of communication available to them, combining, for instance, gesture and speech; (3) the informal assessment of clinical skills, and the intricate relation between trainee performance and supervisor feedback; (4) the potentialities and limitations of different visual learning materials, such as textbooks and videos, for representing medical knowledge. The paper concludes with theoretical and methodological reflections on what can be made visible, and therefore available for analysis, explanation and evaluation if visual materials are used for clinical education research, and what remains unaccounted for if written language remains the dominant mode in the research cycle. Opportunities for quantitative analysis and ethical implications are also discussed. © 2016 John Wiley

  2. Public information about clinical trials and research.

    Science.gov (United States)

    Plétan, Yannick; Zannad, Faïez; Jaillon, Patrice

    2003-01-01

    Be it to restore the confused image of clinical research in relation to the lay public, or to develop new ways of accruing healthy volunteers or patients for clinical trials, there is a need to draft some guidance on how best to provide information on research. Although the French legal and regulatory armamentarium in this area is essentially liberal, there is currently little-justified reluctance among study sponsors to advertise publicly. A group of academic and pharmaceutical industry researchers, assembled for a workshop, together with regulators, journalists, representatives from ethics committees, social security, patient and health consumer groups and other French institutional bodies, has suggested the following series of recommendations: there is no need for additional legal or regulatory constraints; sponsors should be aware of and make use of direct public information on trials; a 'good practice charter' on public communication about clinical trials should be developed; all professionals should be involved in this communication platform; communication in the patient's immediate vicinity should be preferred (primary-care physician, local press); clinical databases and websites accessible to professionals, but also to patients and non-professionals, should be developed; genuine instruction on clinical trials for physicians and health professionals unfamiliar with such trials should be developed and disseminated; media groups should receive at least some training in the fundamentals of clinical research.

  3. Consumer Ethics Research: Reframing the Debate About Consumption for Good

    OpenAIRE

    Brinkmann, Johannes; Peattie, Ken

    2009-01-01

    Originally published in the journal Electronic Journal of Business Ethics and Organization Studies (EJBO): http://ejbo.jyu.fi/archives/vol13_no1.html Consumer ethics is an underdeveloped specialism of business and marketing ethics, within which most publications have focused on bad rather than on good ethics, and on consumer dishonesty rather than on consumer idealism or consumer responsibility. This conceptual paper explores the latter perspective, and examines how we can seek to under...

  4. Delivering research data management services fundamentals of good practice

    CERN Document Server

    Jones, Sarah; Whyte, Angus

    2014-01-01

    The research landscape is changing, with key global research funders now requiring institutions to demonstrate how they will preserve and share research data. However, the practice of structured research data management is very new, and the construction of services remains experimental and in need of models and standards of approach. This groundbreaking guide will lead researchers, institutions and policy makers through the processes needed to set up and run effective institutional research data management services. This book will provide a step-by-step explanation of the components for an institutional service - effectively a 'how to guide'. Case studies from the newly emerging service infrastructures in the UK, USA and Australia will draw out the lessons learnt from working (or near to delivery) exemplars. Different approaches are highlighted and compared, for example, a case study of a researcher-focused strategy from Australia contrasted with a national, top-down approach. A chapter on the redeveloped UK ...

  5. MR spectroscopy in clinical research

    DEFF Research Database (Denmark)

    Henriksen, O

    1994-01-01

    MR spectroscopy (MRS) offers unique possibilities for non-invasive evaluation of biochemistry in vivo. During recent years there has been a growing body of evidence from clinical research studies on human beings using 31P and 1H MRS. The results indicate that it is possible to evaluate phosphorous...

  6. What makes a good clinical student and teacher? An exploratory study

    OpenAIRE

    Goldie, John; Dowie, Al; Goldie, Anne; Cotton, Phil; Morrison, Jill

    2015-01-01

    Background What makes a good clinical student is an area that has received little coverage in the literature and much of the available literature is based on essays and surveys. It is particularly relevant as recent curricular innovations have resulted in greater student autonomy. We also wished to look in depth at what makes a good clinical teacher. \\ud \\ud Methods A qualitative approach using individual interviews with educational supervisors and focus groups with senior clinical students w...

  7. What makes a good clinical student and teacher? An exploratory study.

    Science.gov (United States)

    Goldie, John; Dowie, Al; Goldie, Anne; Cotton, Phil; Morrison, Jill

    2015-03-10

    What makes a good clinical student is an area that has received little coverage in the literature and much of the available literature is based on essays and surveys. It is particularly relevant as recent curricular innovations have resulted in greater student autonomy. We also wished to look in depth at what makes a good clinical teacher. A qualitative approach using individual interviews with educational supervisors and focus groups with senior clinical students was used. Data was analysed using a "framework" technique. Good clinical students were viewed as enthusiastic and motivated. They were considered to be proactive and were noted to be visible in the wards. They are confident, knowledgeable, able to prioritise information, flexible and competent in basic clinical skills by the time of graduation. They are fluent in medical terminology while retaining the ability to communicate effectively and are genuine when interacting with patients. They do not let exam pressure interfere with their performance during their attachments. Good clinical teachers are effective role models. The importance of teachers' non-cognitive characteristics such as inter-personal skills and relationship building was particularly emphasised. To be effective, teachers need to take into account individual differences among students, and the communicative nature of the learning process through which students learn and develop. Good teachers were noted to promote student participation in ward communities of practice. Other members of clinical communities of practice can be effective teachers, mentors and role models. Good clinical students are proactive in their learning; an important quality where students are expected to be active in managing their own learning. Good clinical students share similar characteristics with good clinical teachers. A teacher's enthusiasm and non-cognitive abilities are as important as their cognitive abilities. Student learning in clinical settings is a

  8. Where does good quality qualitative health care research get published?

    Science.gov (United States)

    Richardson, Jane C; Liddle, Jennifer

    2017-09-01

    This short report aims to give some insight into current publication patterns for high-quality qualitative health research, using the Research Excellence Framework (REF) 2014 database. We explored patterns of publication by range and type of journal, by date and by methodological focus. We also looked at variations between the publications submitted to different Units of Assessment, focussing particularly on the one most closely aligned with our own research area of primary care. Our brief analysis demonstrates that general medical/health journals with high impact factors are the dominant routes of publication, but there is variation according to the methodological approach adopted by articles. The number of qualitative health articles submitted to REF 2014 overall was small, and even more so for articles based on mixed methods research, qualitative methodology or reviews/syntheses that included qualitative articles.

  9. The ethics of good communication in a complex research partnership.

    Science.gov (United States)

    Sodeke, Stephen; Turner, Timothy; Tarver, Will

    2010-08-01

    The tripartite partnership among Morehouse School of Medicine, Tuskegee University, and University of Alabama at Birmingham is complex. In 2005, the three schools--with different institutional cultures, characters, and resources--agreed to collaborate in efforts to eliminate racial/ethnic disparities in cancer burdens. Pursuing this laudable aim predictably involved some miscommunication. The Bioethics Shared Resource (BSR) group foresaw such challenges and monitored interactions to prevent harm, noting that while effective communication is critical to the achievement of mutual goals, an understanding and prudent use of proven communication principles is a sine qua non for success. In this commentary, we share the undergirding moral concepts, communication approaches, and lessons learned. This experience has led us to propose an ethics of good communication for others to consider.

  10. NIH Clinical Research Trials and You

    Science.gov (United States)

    ... Info Lines Health Services Locator HealthCare.gov NIH Clinical Research Trials and You Talking to Your Doctor Science ... Labs & Clinics Training Opportunities Library Resources Research Resources Clinical Research Resources Safety, Regulation and Guidance More » Quick Links ...

  11. [Research activity in clinical biochemistry].

    Science.gov (United States)

    Jørgensen, Henrik L; Larsen, Birger; Ingwersen, Peter; Rehfeld, Jens F

    2008-09-01

    Quantitative bibliometric measurements of research activity are frequently used, e.g. for evaluating applicants for academic positions. The purpose of this investigation is to assess research activity within the medical speciality of Clinical Biochemistry by comparing it with a matched control group from other medical specialities in Denmark. A list of all physicians registered in Denmark (23,127 persons) was drawn from the database "Laeger.dk". Of these, 5,202 were generalists (not included) while 11,691 were from other specialities. Of the 126 specialists from Clinical Biochemistry, 57 fulfilled the inclusion criteria. Each of these 57 was matched according to medical title with two randomly chosen specialists from other specialities, totaling 114. Using Medline and the Web of Science, the number of publications and the number of citations were then ascertained. 25% of the 11,691 specialists held a PhD degree or doctoral degree, DMSci, (Clinical Biochemistry: 61%). The 171 specialists included in the study had 9,823 papers in Medline and 10,140 papers in the Web of Science. The number of Medline papers per specialist was 71 for Clinical Biochemistry compared to 51 for the control group. The number of citations per specialist was 1,844 for Clinical Biochemistry compared to 816 for the control group. The top ten H-indices (of which 8 were in Clinical Biochemistry) ranged from 30 to 69. Both the number of papers and the number of citations were higher for Clinical Biochemistry than for the control group. The difference was most pronounced among professors.

  12. Bias in clinical intervention research

    DEFF Research Database (Denmark)

    Gluud, Lise Lotte

    2006-01-01

    Research on bias in clinical trials may help identify some of the reasons why investigators sometimes reach the wrong conclusions about intervention effects. Several quality components for the assessment of bias control have been suggested, but although they seem intrinsically valid, empirical...... evidence is needed to evaluate their effects on the extent and direction of bias. This narrative review summarizes the findings of methodological studies on the influence of bias in clinical trials. A number of methodological studies suggest that lack of adequate randomization in published trial reports...

  13. To Give Good Science: Doing Qualitative Research in the Afterward

    Science.gov (United States)

    Lather, Patti

    2014-01-01

    This article explores the "afterward" for qualitative research in the ruins of NCLB and its failure to deliver. In the space opened up "after" the dominance of the gold standard bullying and "metric mania" of neo-positivism, I articulate a post-retirement project on the weight of sports in U.S. secondary schools out…

  14. Good Schools: What Research Says about Improving Student Achievement.

    Science.gov (United States)

    Hawley, Willis D.; And Others

    1985-01-01

    This journal, presented in monograph form, reviews research findings in order to identify elements that influence student academic achievement. Sections focus on effective teaching, effect of school leadership on achievement, schoolwide learning environment, learning resources, and parent involvement. An extensive bibliography is included. (DF)

  15. A 'good' ethical review: audit and professionalism in research ethics

    DEFF Research Database (Denmark)

    Douglas-Jones, Rachel

    2015-01-01

    How does one conduct, measure and record a ‘good’ ethical review of biomedical research? To what extent do ethics committees invoke professionalism in researchers and in themselves, and to what extent do they see competence as adherence to a set of standard operating procedures for ethical review......? Drawing on ethnographic fieldwork with the Forum of Ethics Review Committees of Asia and the Pacific (FERCAP), a capacity-building NGO that runs ethics committee trainings and reviews in the Asia Pacific region, I develop an analysis of ethical review and its effects. I focus on a ‘second-order audit’ run...... readings of ‘ethics’. I begin and end with a reflection on the ethical effects of a measurement practice that takes ethics itself as its object....

  16. Design Research and Practice for the Public Good: A Reflection

    Directory of Open Access Journals (Sweden)

    Sabine Junginger

    Full Text Available Public sector managers and policymakers have begun to work with design researchers and design practitioners in an effort to create citizen-centric polices and user-centered public services. What role can design play in the approach taken by the public sector in organizational development and innovation? This paper reflects on an innovation project at a Brazilian Ministry where human-centered design was chosen as an approach to integrate innovation efforts among different government agencies and ministries. It offers an example of how human-centered design approaches can support efforts by civil servants to change their own design practices. Keywords: Design research, Design practice, Public sector, Civil servants, Organizational change & development

  17. Doing Arts-Based Educational Research for the Public Good: An Impossible Possibility?

    Science.gov (United States)

    O'Donoghue, Donal

    2014-01-01

    In this special issue, each author addresses how arts-based educational research (ABER) work connects with and/or directly addresses society's need/s and the public good as perceived by the researcher. As there are many construals of the "public good" and the relation to art-making and the arts to this "public good," each…

  18. Good collaborative practice: reforming capacity building governance of international health research partnerships.

    Science.gov (United States)

    Ward, Claire Leonie; Shaw, David; Sprumont, Dominique; Sankoh, Osman; Tanner, Marcel; Elger, Bernice

    2018-01-08

    In line with the policy objectives of the United Nations Sustainable Development Goals, this commentary seeks to examine the extent to which provisions of international health research guidance promote capacity building and equitable partnerships in global health research. Our evaluation finds that governance of collaborative research partnerships, and in particular capacity building, in resource-constrained settings is limited but has improved with the implementation guidance of the International Ethical Guidelines for Health-related Research Involving Humans by The Council for International Organizations of Medical Sciences (CIOMS) (2016). However, more clarity is needed in national legislation, industry and ethics guidelines, and regulatory provisions to address the structural inequities and power imbalances inherent in international health research partnerships. Most notably, ethical partnership governance is not supported by the principal industry ethics guidelines - the International Conference on Harmonization Technical Requirements for Registration of Pharmaceutical for Human Use (ICH) Good Clinical Practice (ICH-GCP). Given the strategic value of ICH-GCP guidelines in defining the role and responsibility of global health research partners, we conclude that such governance should stipulate the minimal requirements for creating an equitable environment of inclusion, mutual learning, transparency and accountability. Procedurally, this can be supported by i) shared research agenda setting with local leadership, ii) capacity assessments, and iii) construction of a memorandum of understanding (MoU). Moreover, the requirement of capacity building needs to be coordinated amongst partners to support good collaborative practice and deliver on the public health goals of the research enterprise; improving local conditions of health and reducing global health inequality. In this respect, and in order to develop consistency between sources of research governance, ICH

  19. Research and clinical practice relationship

    Directory of Open Access Journals (Sweden)

    Ashammakhi N

    2008-01-01

    Full Text Available To The Editor: I highly value and greet the authors for their editorial. Many important issues related to medical education and its future in Libya have been discussed in this paper [1]. One important point that has been addressed and I feel deserves attention is the “abnormal” relationship between clinical practice and research in Libya. From discussions with colleagues, this problem somehow has evolved from a misconception about educational and training systems that may have occurred in the past. It may also be related to the lack of attention to research that has long existed in Libya [2,3]. The other aspect, shared with many other developing countries, is the misconception of research as unimportant or a luxury aspect of medicine. When it comes to understanding how a system (including healthcare can be updated and developed, the answer is vague! One important reason is a lack of understanding of the impact that research has on developing methods. In developed countries, research is the main academic distinction that leads to appointments for coveted positions in the system and is an important factor for academic promotion. In Libya, there remain arguments about who will be awarded Chair of university clinical departments. Such a post should no doubt be given to those with established academic achievements. When highly qualified persons are at the top of the pyramid this leads to further progress and enhanced research and advancement. The authors have discussed the point of having proper search committees for leadership and faculty positions. I believe that it will help eliminate the current stagnation and help to create innovative solutions. This should lead to improved medical education, health services, and ultimately impact the quality of life of all Libyan citizens.

  20. Professional impact of clinical research

    Energy Technology Data Exchange (ETDEWEB)

    Nelhans, G.

    2016-07-01

    In this study, professional impact is defined as the academic literature that is cited in the literature that is used by professions in order to pursue skilled activities that are specific to their expertise. Specifically, we are focusing on the clinical guidelines that are used in the many health and medical professions that are issued by government bodies at national and international levels to ensure a certain quality level and to make results comparable at the national level. To date, more than 50.000 references have been identified in about 500 Swedish clinical guidelines issued by the above mentioned governmental bodies in Sweden. Of these, 73 % of the references have been matched to a PubMed id. The goal of this project is to develop a conceptual and theoretical contribution to the development of indicators for measuring the impact of research outside of the specifically academic literature. (Author)

  1. Practice-based Research Network Research Good Practices (PRGPs): Summary of Recommendations.

    Science.gov (United States)

    Dolor, Rowena J; Campbell-Voytal, Kimberly; Daly, Jeanette; Nagykaldi, Zsolt J; O'Beirne, Maeve; Sterling, Pamela; Fagnan, Lyle J; Levy, Barcey; Michaels, LeAnn; Louks, Hannah A; Smith, Paul; Aspy, Cheryl B; Patterson, V Beth; Kano, Miria; Sussman, Andrew L; Williams, Robert; Neale, Anne Victoria

    2015-12-01

    Practice-based research networks (PBRNs) conduct research in community settings, which poses quality control challenges to the integrity of research, such as study implementation and data collection. A foundation for improving research processes within PBRNs is needed to ensure research integrity. Network directors and coordinators from seven U.S.-based PBRNs worked with a professional team facilitator during semiannual in-person meetings and monthly conference calls to produce content for a compendium of recommended research practices specific to the context of PBRNs. Participants were assigned to contribute content congruent with their expertise. Feedback on the draft document was obtained from attendees at the preconference workshop at the annual PBRN meeting in 2013. A revised document was circulated to additional PBRN peers prior to finalization. The PBRN Research Good Practices (PRGPs) document is organized into four chapters: (1) Building PBRN Infrastructure; (2) Study Development and Implementation; (3) Data Management, and (4) Dissemination Policies. Each chapter contains an introduction, detailed procedures for each section, and example resources with information links. The PRGPs is a PBRN-specific resource to facilitate PBRN management and staff training, to promote adherence to study protocols, and to increase validity and generalizability of study findings. © 2015 Wiley Periodicals, Inc.

  2. Modeling good research practices--overview: a report of the ISPOR-SMDM Modeling Good Research Practices Task Force--1.

    Science.gov (United States)

    Caro, J Jaime; Briggs, Andrew H; Siebert, Uwe; Kuntz, Karen M

    2012-01-01

    Models--mathematical frameworks that facilitate estimation of the consequences of health care decisions--have become essential tools for health technology assessment. Evolution of the methods since the first ISPOR Modeling Task Force reported in 2003 has led to a new Task Force, jointly convened with the Society for Medical Decision Making, and this series of seven articles presents the updated recommendations for best practices in conceptualizing models; implementing state-transition approaches, discrete event simulations, or dynamic transmission models; and dealing with uncertainty and validating and reporting models transparently. This overview article introduces the work of the Task Force, provides all the recommendations, and discusses some quandaries that require further elucidation. The audience for these articles includes those who build models, stakeholders who utilize their results, and, indeed, anyone concerned with the use of models to support decision making. Copyright © 2012 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

  3. Surviving a Site Audit: Tips for Good Clinical Practice in an Implant Trial

    NARCIS (Netherlands)

    E.M.M. van Lieshout (Esther); S.M. Zielinski (Stephanie)

    2009-01-01

    textabstractAbstract The number of clinical trials involving implants for trauma and orthopedic surgery is increasing. The International Conference of Harmonization-Good Clinical Practice (ICH-GCP) guideline has been developed in order to assure that the rights, safety, and well-being of trial

  4. Clinical Epidemiology Unit - overview of research areas

    Science.gov (United States)

    Clinical Epidemiology Unit (CEU) conducts etiologic research with potential clinical and public health applications, and leads studies evaluating population-based early detection and cancer prevention strategies

  5. Establishing good collaborative research practices in the responsible conduct of research in nursing science.

    Science.gov (United States)

    Ulrich, Connie M; Wallen, Gwenyth R; Cui, Naixue; Chittams, Jesse; Sweet, Monica; Plemmons, Dena

    2015-01-01

    Team science is advocated to speed the pace of scientific discovery, yet the goals of collaborative practice in nursing science and the responsibilities of nurse stakeholders are sparse and inconclusive. The purpose of this study was to examine nurse scientists' views on collaborative research as part of a larger study on standards of scientific conduct. Web-based descriptive survey of nurse scientists randomly selected from 50 doctoral graduate programs in the United States. Nearly forty percent of nurse respondents were not able to identify good collaborative practices for the discipline; more than three quarters did not know of any published guidelines available to them. Successful research collaborations were challenged by different expectations of authorship and data ownership, lack of timeliness and communication, poorly defined roles and responsibilities, language barriers, and when they involve junior and senior faculty working together on a project. Individual and organizational standards, practices, and policies for collaborative research needs clarification within the discipline. Copyright © 2015 Elsevier Inc. All rights reserved.

  6. Be a Partner in Clinical Research

    Science.gov (United States)

    ... 2015 Print this issue Be a Partner in Clinical Research Help Others, Help Yourself En español Send us ... Did you know that you can participate in clinical research? Whether you’re healthy or sick, young or ...

  7. Traditional Chinese medicine research in the post-genomic era: good practice, priorities, challenges and opportunities.

    Science.gov (United States)

    Uzuner, Halil; Bauer, Rudolf; Fan, Tai-Ping; Guo, De-An; Dias, Alberto; El-Nezami, Hani; Efferth, Thomas; Williamson, Elizabeth M; Heinrich, Michael; Robinson, Nicola; Hylands, Peter J; Hendry, Bruce M; Cheng, Yung-Chi; Xu, Qihe

    2012-04-10

    GP-TCM is the 1st EU-funded Coordination Action consortium dedicated to traditional Chinese medicine (TCM) research. This paper aims to summarise the objectives, structure and activities of the consortium and introduces the position of the consortium regarding good practice, priorities, challenges and opportunities in TCM research. Serving as the introductory paper for the GP-TCM Journal of Ethnopharmacology special issue, this paper describes the roadmap of this special issue and reports how the main outputs of the ten GP-TCM work packages are integrated, and have led to consortium-wide conclusions. Literature studies, opinion polls and discussions among consortium members and stakeholders. By January 2012, through 3 years of team building, the GP-TCM consortium had grown into a large collaborative network involving ∼200 scientists from 24 countries and 107 institutions. Consortium members had worked closely to address good practice issues related to various aspects of Chinese herbal medicine (CHM) and acupuncture research, the focus of this Journal of Ethnopharmacology special issue, leading to state-of-the-art reports, guidelines and consensus on the application of omics technologies in TCM research. In addition, through an online survey open to GP-TCM members and non-members, we polled opinions on grand priorities, challenges and opportunities in TCM research. Based on the poll, although consortium members and non-members had diverse opinions on the major challenges in the field, both groups agreed that high-quality efficacy/effectiveness and mechanistic studies are grand priorities and that the TCM legacy in general and its management of chronic diseases in particular represent grand opportunities. Consortium members cast their votes of confidence in omics and systems biology approaches to TCM research and believed that quality and pharmacovigilance of TCM products are not only grand priorities, but also grand challenges. Non-members, however, gave priority

  8. Stuttering: Clinical and research update.

    Science.gov (United States)

    Perez, Hector R; Stoeckle, James H

    2016-06-01

    To provide an update on the epidemiology, genetics, pathophysiology, diagnosis, and treatment of developmental stuttering. The MEDLINE and Cochrane databases were searched for past and recent studies on the epidemiology, genetics, pathophysiology, diagnosis, and treatment of developmental stuttering. Most recommendations are based on small studies, limited-quality evidence, or consensus. Stuttering is a speech disorder, common in persons of all ages, that affects normal fluency and time patterning of speech. Stuttering has been associated with differences in brain anatomy, functioning, and dopamine regulation thought to be due to genetic causes. Attention to making a correct diagnosis or referral in children is important because there is growing consensus that early intervention with speech therapy for children who stutter is critical. For adults, stuttering can be associated with substantial psychosocial morbidity including social anxiety and low quality of life. Pharmacologic treatment has received attention in recent years, but clinical evidence is limited. The mainstay of treatment for children and adults remains speech therapy. A growing body of research has attempted to uncover the pathophysiology of stuttering. Referral for speech therapy remains the best option for children and adults. Copyright© the College of Family Physicians of Canada.

  9. Ethics in clinical research: The Indian perspective

    OpenAIRE

    J Sanmukhani; C B Tripathi

    2011-01-01

    Ethics in clinical research focuses largely on identifying and implementing the acceptable conditions for exposure of some individuals to risks and burdens for the benefit of society at large. Ethical guidelines for clinical research were formulated only after discovery of inhumane behaviour with participants during research experiments. The Nuremberg Code was the first international code laying ethical principles for clinical research. With increasing research all over, World Health Organiza...

  10. Construction of ethics in clinical research: clinical trials registration

    OpenAIRE

    C. A. Caramori

    2007-01-01

    Scientific development that has been achieved through decades finds in clinical research a great possibility of translating findings to human health application. Evidence given by clinical trials allows everyone to have access to the best health services. However, the millionaire world of pharmaceutical industries has stained clinical research with doubt and improbability. Study results (fruits of controlled clinical trials) and scientific publications (selective, manipulated and with wrong c...

  11. Essential Ingredients of a Good Research Proposal for Undergraduate and Postgraduate Students in the Social Sciences

    Directory of Open Access Journals (Sweden)

    Raymond Talinbe Abdulai

    2014-08-01

    Full Text Available As part of the requirements for the award of degrees in higher education institutions, students at undergraduate and postgraduate levels normally carry out research, which they report in the form of dissertations or theses. The research journey commences with the selection of a research topic and the preparation of a proposal on the selected topic. Experience has shown that students tend to encounter difficulties in writing research proposals for their supervisors because they do not fully comprehend what constitutes a research proposal. The purpose of this article is to take students through a step-by-step process of writing good research proposals by discussing the essential ingredients of a good research proposal. Thus, it is not a didactic piece—the aim is to guide students in research proposal writing. In discussing these ingredients, relevant examples are provided where necessary for ease of understanding. It is expected that on reading this article, students should be able to: (a demonstrate knowledge and understanding of what research is all about and its challenging nature; (b display an enlarged comprehension of research gap(s, problem or question(s, aim, objectives, and hypotheses as well as their distinguishing characteristics; (c demonstrate a good understanding of the relevant elements to be considered in the constituent sections of a good research proposal; and (d comprehend the elements of a research proposal that should feature in the final written dissertation or thesis.

  12. A survey of patients' attitudes to clinical research.

    LENUS (Irish Health Repository)

    Desmond, A

    2011-04-01

    Every year hundreds of patients voluntarily participate in clinical trials across Ireland. However, little research has been done as to how patients find the experience. This survey was conducted in an attempt to ascertain clinical trial participants\\' views on their experience of participating in a clinical trial and to see and how clinical trial participation can be improved. One hundred and sixty-six clinical trial participants who had recently completed a global phase IV cardiovascular endpoint clinical trial were sent a 3-page questionnaire. Ninety-one (91%) respondents found the experience of participating in a clinical trial a good one with 85 (84.16%) respondents saying they would recommend participating in a clinical trial to a friend or relative and eighty-five (87.63%) respondents feeling they received better healthcare because they had participated in a clinical trial.

  13. 76 FR 17138 - Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good...

    Science.gov (United States)

    2011-03-28

    ... initiated research. Topics for discussion include the following: (1) What FDA Expects in a Pharmaceutical Clinical Trial; (2) Adverse Event Reporting--Science, Regulation, Error, and Safety; (3) Part 11 Compliance...

  14. The changing landscape for clinical research.

    Science.gov (United States)

    Heinig, S J; Quon, A S; Meyer, R E; Korn, D

    1999-06-01

    The authors review the history of U.S. clinical research and identify the profound changes stemming from advancements in the biomedical sciences, the recent transformation in the organization and financing of health care delivery, and the increasing application of information technologies. They observe that the enterprise must reorganize to account for the changed landscape, but there is a lack of the data necessary to monitor change and determine the extent to which clinical research is successfully realigning and sustaining itself. The authors discuss the evolving definition, scope, and venues for clinical research, and review previous analyses of clinical research's difficulties and remedies proposed: shared responsibility in the financing of academic medicine, support by federal and private health insurers for routine costs of patient care in clinical trials, and strengthened collaboration between and among industry, academia, insurers, and government. The authors conclude by describing two major initiatives to foster clinical investigation in the new landscape. The first is the Clinical Research Summit Project, a convocation of representative stakeholders from the health care system with an interest in clinical research, whose charge will be to formulate a national agenda for clinical research that has the broad-based support of the stakeholders. Among the challenges of this undertaking are the needs to identify new and stable sources of support for clinical research infrastructure, assess the future workforce needs for clinical investigation, and devise new methods to ensure the continued vitality and account-ability of clinical research. The second is the Clinical Research Task Force, an initiative of the Association of American Medical Colleges (AAMC), which is already exploring and advising on how AAMC member organizations can best strengthen their capacity to support clinical research programs in the current scientific, health care delivery, and financial

  15. Student teachers can be as good as associate professors in teaching clinical skills

    DEFF Research Database (Denmark)

    Tolsgaard, Martin G; Gustafsson, Amandus; Rasmussen, Maria B

    2007-01-01

    AIM: The aim of this study is to compare student teachers and clinical associate professors regarding the quality of procedural skills teaching in terms of participants' technical skills, knowledge and satisfaction with the teaching. METHODS: This is an experimental, randomized, controlled study....... CONCLUSION: Trained student teachers can be as good as associate professors in teaching clinical skills. Udgivelsesdato: 2007-Sep...... comparing the teaching of student teachers and associate professors regarding participants' learning outcome and satisfaction with the teaching. Two skills are chosen for the experiment, i.v.-access and bladder catheterization. Learning outcome is assessed by a pre- and post testing of the participants...

  16. Construction of ethics in clinical research: clinical trials registration

    Directory of Open Access Journals (Sweden)

    C. A. Caramori

    2007-01-01

    Full Text Available Scientific development that has been achieved through decades finds in clinical research a great possibility of translating findings to human health application. Evidence given by clinical trials allows everyone to have access to the best health services. However, the millionaire world of pharmaceutical industries has stained clinical research with doubt and improbability. Study results (fruits of controlled clinical trials and scientific publications (selective, manipulated and with wrong conclusions led to an inappropriate clinical practice, favoring the involved economic aspect. In 2005, the International Committee of Medical Journal Editors (ICMJE, supported by the World Association of Medical Editors, started demanding as a requisite for publication that all clinical trials be registered at the database ClinicalTrials.gov. In 2006, the World Health Organization (WHO created the International Clinical Trial Registry Platform (ICTRP, which gathers several registry centers from all over the world, and required that all researchers and pharmaceutical industries register clinical trials. Such obligatory registration has progressed and will extend to all scientific journals indexed in all worldwide databases. Registration of clinical trials means another step of clinical research towards transparency, ethics and impartiality, resulting in real evidence to the forthcoming changes in clinical practice as well as in the health situation.

  17. Tools to share good chairside teaching practice: a clinical scenario and appreciative questionnaire.

    Science.gov (United States)

    Sweet, J; Wilson, J; Pugsley, L; Schofield, M

    2008-12-13

    This article provides a scenario for analysis of good chairside teaching practice to serve as a starting point for continued discussion in this complex field. Documented issues of good chairside teaching practice are cross-referenced to a clinical scenario with explanations in the form of a commentary. This provided the context for generating a set of questions that are provided as tools to support good chairside practice. These tools are designed to be used with 'Appreciative Inquiry', which claims that there is much to be gained by discovering where excellence is possible and elaborating upon this. Although this process can be carried out in single units or departments, it is proposed that collaboration between institutions would allow sharing of valuable innovations and greater understanding of educational training, production of good practice guidance and professional development of staff. This article is the third in a series of three and provides a scaffold for a scenario and questions to encourage collaboration in evolving and sharing good chairside teaching practice. The first article investigated the perceptions of stakeholders in chairside teaching at a single dental school and the second evaluated chairside teaching on a UK wide scale. A further accompanying article reviews some of the educational methodology and innovations in teaching and learning that may be applied to dentistry.

  18. Emerging Good Practice in Managing Research Data and Research Information within UK Universities

    DEFF Research Database (Denmark)

    Davidson, Joy; Jones, Sarah; Molloy, Laura

    2014-01-01

    Sound data intensive science depends upon effective research data and information management. Efficient and interoperable research information systems will be crucial for enabling and exploiting data intensive research however it is equally important that a research ecosystem is cultivated within...... institutions prepare to meet funding body mandates relating to research data management and sharing and to engage fully in the digital agenda.......Sound data intensive science depends upon effective research data and information management. Efficient and interoperable research information systems will be crucial for enabling and exploiting data intensive research however it is equally important that a research ecosystem is cultivated within...... research-intensive institutions that foster sustainable communication, cooperation and support of a diverse range of research-related staff. Researchers, librarians, administrators, ethics advisors, and IT professionals all have a vital contribution to make in ensuring that research data and related...

  19. Infectious Disease Clinical Research Program (IDCRP)

    Data.gov (United States)

    Federal Laboratory Consortium — Our mission is to conduct infectious disease clinical research of importance to the military through a unique, adaptive, and collaborative network, to inform health...

  20. RETHINKING THE ROLE OF CLINICAL TRIAL DATA IN INTERNATIONAL INTELLECTUAL PROPERTY LAW: THE CASE FOR A PUBLIC GOODS APPROACH

    Science.gov (United States)

    REICHMAN, JEROME H.

    2009-01-01

    expense of public health. Although liability rules are better than the status quo, they would not resolve the problem of treating a public good as proprietary. Governments should thus oversee and fund clinical trials as the public good that they are. Clinical tests should be awarded to the most qualified scientists through a competitive process, financed in part with the decrease in drug costs to governmental health care programs and in part with drug developers’ contributions, selected to maximize social benefit, and made global via intergovernmental bodies to maximize social return. This would reduce the cost of redundant investigations to the global public health system, lower supply costs to drug consumers, and lower the breakeven point for investment in research to discover new drugs. PMID:20431702

  1. RETHINKING THE ROLE OF CLINICAL TRIAL DATA IN INTERNATIONAL INTELLECTUAL PROPERTY LAW: THE CASE FOR A PUBLIC GOODS APPROACH.

    Science.gov (United States)

    Reichman, Jerome H

    2009-01-01

    health. Although liability rules are better than the status quo, they would not resolve the problem of treating a public good as proprietary. Governments should thus oversee and fund clinical trials as the public good that they are. Clinical tests should be awarded to the most qualified scientists through a competitive process, financed in part with the decrease in drug costs to governmental health care programs and in part with drug developers' contributions, selected to maximize social benefit, and made global via intergovernmental bodies to maximize social return. This would reduce the cost of redundant investigations to the global public health system, lower supply costs to drug consumers, and lower the breakeven point for investment in research to discover new drugs.

  2. Improvement of Clinical Skills through Pharmaceutical Education and Clinical Research.

    Science.gov (United States)

    Ishizaki, Junko

    2017-01-01

    Professors and teaching staff in the field of pharmaceutical sciences should devote themselves to staying abreast of relevant education and research. Similarly those in clinical pharmacies should contribute to the advancement of pharmaceutical research and the development of next generation pharmacists and pharmaceuticals. It is thought that those who work in clinical pharmacies should improve their own skills and expertise in problem-finding and -solving, i.e., "clinical skills". They should be keen to learn new standard treatments based on the latest drug information, and should try to be in a position where collecting clinical information is readily possible. In the case of pharmacists in hospitals and pharmacies, they are able to aim at improving their clinical skills simply through performing their pharmaceutical duties. On the other hand, when a pharmaceutical educator aims to improve clinical skills at a level comparable to those of clinical pharmacists, it is necessary to devote or set aside considerable time for pharmacist duties, in addition to teaching, which may result in a shortage of time for hands-on clinical practice and/or in a decline in the quality of education and research. This could be a nightmare for teaching staff in clinical pharmacy who aim to take part in such activities. Nonetheless, I believe that teaching staff in the clinical pharmacy area could improve his/her clinical skills through actively engaging in education and research. In this review, I would like to introduce topics on such possibilities from my own experiences.

  3. On-site management of investigational products and drug delivery systems in conformity with Good Clinical Practices (GCPs).

    Science.gov (United States)

    Méthot, Julie; Brisson, Diane; Gaudet, Daniel

    2012-04-01

    Investigators and research teams participating in clinical trials have to deal with complex investigational products, study designs, and research environments. The emergence of new drug delivery systems and investigational products combining more than one drug and the development of biodrugs such as monoclonal antibodies, peptides, siRNA, and gene therapy to treat orphan or common diseases constitute a new challenge for investigators and clinical sites. We describe the requirements and challenges of drug management in conformity with Good Clinical Practices (GCPs) for investigators and sites participating in clinical trials. Review At all sites participating in clinical trials, standard operating procedures (SOPs) covering the critical path of drug and drug delivery systems management are required. All steps should be auditable, including reception, validation, storage, access, preparation, distribution, techniques of administration, use, return, and destruction of research products. Biodrugs require traceability and specific SOPs on the management of potential immune reactions. Investigational products must be stored under standard auditable conditions. The traceability of storage conditions (including temperature) requires these conditions to be monitored on a continuous basis. A dedicated space with restricted access limited to authorized qualified personnel facilitates the monitoring. The development of standardized, auditable settings and the application of dedicated, site-specific SOPs for the management of investigational products and drug delivery systems contribute to guarantee the compliance to GCP requirements.

  4. On Informatics Diagnostics and Informatics Therapeutics - Good Medical Informatics Research Is Needed Here.

    Science.gov (United States)

    Haux, Reinhold

    2017-01-01

    In the era of digitization some new procedures play an increasing role for diagnosis as well as for therapy: informatics diagnostics and informatics therapeutics. Challenges for such procedures are described. It is discussed, when research on such diagnostics and therapeutics can be regarded as good research. Examples are mentioned for informatics diagnostics and informatics therapeutics, which are based on health-enabling technologies.

  5. Modern Clinical Research on LSD

    OpenAIRE

    Liechti, Matthias E.

    2017-01-01

    All modern clinical studies using the classic hallucinogen lysergic acid diethylamide (LSD) in healthy subjects or patients in the last 25 years are reviewed herein. There were five recent studies in healthy participants and one in patients. In a controlled setting, LSD acutely induced bliss, audiovisual synesthesia, altered meaning of perceptions, derealization, depersonalization, and mystical experiences. These subjective effects of LSD were mediated by the 5-HT2A receptor. LSD increased fe...

  6. The importance of Clinical Research

    Directory of Open Access Journals (Sweden)

    Frank Lizaraso Caparó

    2016-01-01

    Full Text Available Objetives: to describe the clinical and epidemiological characteristics, evolution and to identify mortality factors associated in patients with snp.Material and methods: descriptive study of a serie of cases of the intensive care unit (icu of a general hospital. medical records of patients which received medical attention and who meet the selection criteria were reviewed. Results: forty-one clinical records were evaluated. the average age was 69 old, predominantly male (68,3%. snp was the reason of admission in 60.9% and 95.1% required mechanical ventilation. hospital stay prior to diagnosis was 10 days, 65% of patients had some risk factor for multi resistence organisms, cpis of entry was 9.3, cultures were positive in 39% of the cases and of these, 48.8% received proper antibiotic according to culture results. the days of stay in icu were 20.6 days and 20 of the 41 medical records were for death patients. the clinical and epidemiological characteristics were similar between death and alive patients. an analysis of factors that could be associated with mortality snp was made and it was found that for an age ≥ 70 years, the presence of any risk factor for multidrug resistence organism and control cpis ≥ 6 were associated with higher mortality; while acquisition of the icu was associated to lower mortality. Conclusions: the clinical, epidemiological characteristics and evolution of patients with snp in our icu were similar to those describe in the literature. three factors associated with mortality in the icu were identified.

  7. Database on veterinary clinical research in homeopathy.

    Science.gov (United States)

    Clausen, Jürgen; Albrecht, Henning

    2010-07-01

    The aim of the present report is to provide an overview of the first database on clinical research in veterinary homeopathy. Detailed searches in the database 'Veterinary Clinical Research-Database in Homeopathy' (http://www.carstens-stiftung.de/clinresvet/index.php). The database contains about 200 entries of randomised clinical trials, non-randomised clinical trials, observational studies, drug provings, case reports and case series. Twenty-two clinical fields are covered and eight different groups of species are included. The database is free of charge and open to all interested veterinarians and researchers. The database enables researchers and veterinarians, sceptics and supporters to get a quick overview of the status of veterinary clinical research in homeopathy and alleviates the preparation of systematical reviews or may stimulate reproductions or even new studies. 2010 Elsevier Ltd. All rights reserved.

  8. MARKET RESEARCH OF CARE GOODS FOR NEWBORNS AND FIRST YEAR CHILDREN

    Directory of Open Access Journals (Sweden)

    A. I. Ovod

    2015-01-01

    Full Text Available Comparative results of marketing research of care goods for newborns and first year children conducted in 2009 and 2014 showed that there were changes in the range of products and consumer preferences. The analysis revealed that the economic situation affected the determinants of choice in this category of goods and the location of purchasing. The findings should be considered by pharmaceutical companies in their procurement in order to improve their competitive position. 

  9. Ethical Issues in Internet Research: International Good Practice and Irish Research Ethics Documents

    Science.gov (United States)

    Felzmann, Heike

    2013-01-01

    This chapter discusses the main research ethical concerns that arise in internet research and reviews existing research ethical guidance in the Irish context in relation to its application to internet research. The chapter begins with a brief outline of high profile cases in the early history of the internet that highlighted specific emerging…

  10. Chloracne: From clinic to research

    Directory of Open Access Journals (Sweden)

    Qiang Ju

    2012-03-01

    Full Text Available Chloracne is the most sensitive and specific marker for a possible dioxin (2,3,7,8-tetrachlorodibenzo-p-dioxin intoxication. It is clinically characterized by multiple acneiform comedone-like cystic eruptions mainly involving face in the malar, temporal, mandibular, auricular/retroauricular regions, and the genitalia, often occurring in age groups not typical for acne vulgaris. Histopathology is essential for a definite diagnosis, which exhibits atrophy or absence of sebaceous glands as well as infundibular dilatation or cystic formation of hair follicles, hyperplasia of epidermis, and hyperpigmentation of stratum corneum. The appearance of chloracne and its clinical severity does not correlate with the blood levels of dioxins. Pathogenesis of chloracne remains largely unclear. An “aryl hydrocarbon receptor”-mediated signaling pathway affecting the multipotent stem cells in the pilosebaceous units is probably the major molecular mechanism inducing chloracne. Chloracne is resistant to all the available treatment modalities used to treat acne. The aim of treatment is to lower or to eliminate the accumulated dioxins in the body at the very beginning of intoxication, e.g., by using dioxin-chelating substances such as synthetic dietary fat substitutes. The problem of dioxin contamination and its potential health hazards should be taken seriously in the wave of industrial globalization in the twenty-first century. Clinicians, especially dermatologists, are in the forefront of early diagnosis of dioxin intoxication.

  11. Antiphospholipid Syndrome Clinical Research Task Force Report

    NARCIS (Netherlands)

    Erkan, D.; Derksen, R.; Levy, R.; Machin, S.; Ortel, T.; Pierangeli, S.; Roubey, R.; Lockshin, M.

    The Antiphospholipid Syndrome (APS) Clinical Research Task Force (CRTF) was one of six Task Forces developed by the 13(th) International Congress on Antiphospholipid Antibodies (aPL) organization committee with the purpose of: a) evaluating the limitations of APS clinical research and developing

  12. The characteristics of a good clinical teacher as perceived by resident physicians in Japan: a qualitative study.

    Science.gov (United States)

    Kikukawa, Makoto; Nabeta, Hiromi; Ono, Maiko; Emura, Sei; Oda, Yasutomo; Koizumi, Shunzo; Sakemi, Takanobu

    2013-07-25

    It is not known whether the characteristics of a good clinical teacher as perceived by resident physicians are the same in Western countries as in non-Western countries including Japan. The objective of this study was to identify the characteristics of a good clinical teacher as perceived by resident physicians in Japan, a non-Western country, and to compare the results with those obtained in Western countries. Data for this qualitative research were collected using semi-structured focus group interviews. Focus group transcripts were independently analyzed and coded by three authors. Residents were recruited by maximum variation sampling until thematic saturation was achieved. Twenty-three residents participated in five focus group interviews regarding the perceived characteristics of a good clinical teacher in Japan. The 197 descriptions of characteristics that were identified were grouped into 30 themes. The most commonly identified theme was "provided sufficient support", followed by "presented residents with chances to think", "provided feedback", and "provided specific indications of areas needing improvement". Using Sutkin's main categories (teacher, physician, and human characteristics), 24 of the 30 themes were categorized as teacher characteristics, 6 as physician characteristics, and none as human characteristics. "Medical knowledge" of teachers was not identified as a concern of residents, and "clinical competence of teachers" was not emphasized, whereas these were the two most commonly recorded themes in Sutkin's study. Our results suggest that Japanese and Western resident physicians place emphasis on different characteristics of their teachers. We speculate that such perceptions are influenced by educational systems, educational settings, and culture. Globalization of medical education is important, but it is also important to consider differences in educational systems, local settings, and culture when evaluating clinical teachers.

  13. Nuclear medical approaches to clinical research

    International Nuclear Information System (INIS)

    Otte, Andreas; Nguyen, Tristan

    2009-01-01

    In the frame of the master course Clinical research management at the scientific college Lahr in cooperation with the Albert-Ludwigs-University Freiburg three contributions are presented: Functional imaging - supported clinical studies in the sleep research. A comparison of NMR imaging versus SPECT and PET (advantages and disadvantages). Clinical studies with ionizing radiation and the radiation fear of the public. The new radioimmunotherapeutic agent Zevalin and the challenges at the market.

  14. Blockchain technology for improving clinical research quality

    OpenAIRE

    Benchoufi, Mehdi; Ravaud, Philippe

    2017-01-01

    Reproducibility, data sharing, personal data privacy concerns and patient enrolment in clinical trials are huge medical challenges for contemporary clinical research. A new technology, Blockchain, may be a key to addressing these challenges and should draw the attention of the whole clinical research community. Blockchain brings the Internet to its definitive decentralisation goal. The core principle of Blockchain is that any service relying on trusted third parties can be built in a transpar...

  15. Measuring and Maximising Research Impact in Applied Social Science Research Settings. Good Practice Guide

    Science.gov (United States)

    Stanwick, John; Hargreaves, Jo

    2012-01-01

    This guide describes the National Centre for Vocational Education Research (NCVER) approach to measuring impact using examples from its own case studies, as well as showing how to maximise the impact of applied social science research. Applied social science research needs to demonstrate that it is relevant and useful both to public policy and…

  16. Conducting feasibilities in clinical trials: An investment to ensure a good study

    Directory of Open Access Journals (Sweden)

    Viraj Rajadhyaksha

    2010-01-01

    Full Text Available Conducting clinical trial feasibility is one of the first steps in clinical trial conduct. This process includes assessing internal and environmental capacity, alignment of the clinical trial in terms of study design, dose of investigational product, comparator, patient type, with the local environment and assessing potential of conducting clinical trial in a specific country. A robust feasibility also ensures a realistic assessment and capability to conduct the clinical trial. For local affiliates of pharmaceutical organizations, and contract research organizations, this is a precursor to study placement and influences the decision of study placement. This article provides details on different types of feasibilities, information which is to be included and relevance of each. The article also aims to provide practical hands-on suggestions to make feasibilities more realistic and informative.

  17. Conducting feasibilities in clinical trials: an investment to ensure a good study.

    Science.gov (United States)

    Rajadhyaksha, Viraj

    2010-07-01

    Conducting clinical trial feasibility is one of the first steps in clinical trial conduct. This process includes assessing internal and environmental capacity, alignment of the clinical trial in terms of study design, dose of investigational product, comparator, patient type, with the local environment and assessing potential of conducting clinical trial in a specific country. A robust feasibility also ensures a realistic assessment and capability to conduct the clinical trial. For local affiliates of pharmaceutical organizations, and contract research organizations, this is a precursor to study placement and influences the decision of study placement. This article provides details on different types of feasibilities, information which is to be included and relevance of each. The article also aims to provide practical hands-on suggestions to make feasibilities more realistic and informative.

  18. Are Leadership and Management Essential for Good Research? An Interview Study of Genetic Researchers.

    Science.gov (United States)

    Antes, Alison L; Mart, Adelina; DuBois, James M

    2016-12-01

    Principal investigators are responsible for a myriad of leadership and management activities in their work. The practices they use to navigate these responsibilities ultimately influence the quality and integrity of research. However, leadership and management roles in research have received scant empirical examination. Semi-structured interviews with 32 National Institutes of Health (NIH)-funded genetic researchers revealed that they considered leadership and management essential for effective research, but their scientific training inadequately prepared them. We also report management practices that the researchers described using in their labs, as well as their perceptions of a proposed intervention to enhance laboratory leadership. These findings suggest best practices for the research community, future directions for scientific training, and implications for research on leadership and management in science.

  19. Are Leadership and Management Essential for Good Research? An Interview Study of Genetic Researchers

    Science.gov (United States)

    Antes, Alison L.; Mart, Adelina; DuBois, James M.

    2016-01-01

    Principal investigators are responsible for a myriad of leadership and management activities in their work. The practices they employ to navigate these responsibilities ultimately influence the quality and integrity of research. However, leadership and management roles in research have received scant empirical examination. Semi-structured interviews with 32 National Institutes of Health (NIH)-funded genetic researchers revealed that they considered leadership and management essential for effective research, but their scientific training inadequately prepared them. We also report management practices that the researchers described employing in their labs, as well as their perceptions of a proposed intervention to enhance laboratory leadership. These findings suggest best practices for the research community, future directions for scientific training, and implications for research on leadership and management in science. PMID:27646401

  20. Electroencephalographic neurofeedback: Level of evidence in mental and brain disorders and suggestions for good clinical practice.

    Science.gov (United States)

    Micoulaud-Franchi, J-A; McGonigal, A; Lopez, R; Daudet, C; Kotwas, I; Bartolomei, F

    2015-12-01

    The technique of electroencephalographic neurofeedback (EEG NF) emerged in the 1970s and is a technique that measures a subject's EEG signal, processes it in real time, extracts a parameter of interest and presents this information in visual or auditory form. The goal is to effectuate a behavioural modification by modulating brain activity. The EEG NF opens new therapeutic possibilities in the fields of psychiatry and neurology. However, the development of EEG NF in clinical practice requires (i) a good level of evidence of therapeutic efficacy of this technique, (ii) a good practice guide for this technique. Firstly, this article investigates selected trials with the following criteria: study design with controlled, randomized, and open or blind protocol, primary endpoint related to the mental and brain disorders treated and assessed with standardized measurement tools, identifiable EEG neurophysiological targets, underpinned by pathophysiological relevance. Trials were found for: epilepsies, migraine, stroke, chronic insomnia, attentional-deficit/hyperactivity disorder (ADHD), autism spectrum disorder, major depressive disorder, anxiety disorders, addictive disorders, psychotic disorders. Secondly, this article investigates the principles of neurofeedback therapy in line with learning theory. Different underlying therapeutic models are presented didactically between two continua: a continuum between implicit and explicit learning and a continuum between the biomedical model (centred on "the disease") and integrative biopsychosocial model of health (centred on "the illness"). The main relevant learning model is to link neurofeedback therapy with the field of cognitive remediation techniques. The methodological specificity of neurofeedback is to be guided by biologically relevant neurophysiological parameters. Guidelines for good clinical practice of EEG NF concerning technical issues of electrophysiology and of learning are suggested. These require validation by

  1. Modern Clinical Research on LSD.

    Science.gov (United States)

    Liechti, Matthias E

    2017-10-01

    All modern clinical studies using the classic hallucinogen lysergic acid diethylamide (LSD) in healthy subjects or patients in the last 25 years are reviewed herein. There were five recent studies in healthy participants and one in patients. In a controlled setting, LSD acutely induced bliss, audiovisual synesthesia, altered meaning of perceptions, derealization, depersonalization, and mystical experiences. These subjective effects of LSD were mediated by the 5-HT 2A receptor. LSD increased feelings of closeness to others, openness, trust, and suggestibility. LSD impaired the recognition of sad and fearful faces, reduced left amygdala reactivity to fearful faces, and enhanced emotional empathy. LSD increased the emotional response to music and the meaning of music. LSD acutely produced deficits in sensorimotor gating, similar to observations in schizophrenia. LSD had weak autonomic stimulant effects and elevated plasma cortisol, prolactin, and oxytocin levels. Resting-state functional magnetic resonance studies showed that LSD acutely reduced the integrity of functional brain networks and increased connectivity between networks that normally are more dissociated. LSD increased functional thalamocortical connectivity and functional connectivity of the primary visual cortex with other brain areas. The latter effect was correlated with subjective hallucinations. LSD acutely induced global increases in brain entropy that were associated with greater trait openness 14 days later. In patients with anxiety associated with life-threatening disease, anxiety was reduced for 2 months after two doses of LSD. In medical settings, no complications of LSD administration were observed. These data should contribute to further investigations of the therapeutic potential of LSD in psychiatry.

  2. Leveraging electronic health records for clinical research.

    Science.gov (United States)

    Raman, Sudha R; Curtis, Lesley H; Temple, Robert; Andersson, Tomas; Ezekowitz, Justin; Ford, Ian; James, Stefan; Marsolo, Keith; Mirhaji, Parsa; Rocca, Mitra; Rothman, Russell L; Sethuraman, Barathi; Stockbridge, Norman; Terry, Sharon; Wasserman, Scott M; Peterson, Eric D; Hernandez, Adrian F

    2018-04-30

    Electronic health records (EHRs) can be a major tool in the quest to decrease costs and timelines of clinical trial research, generate better evidence for clinical decision making, and advance health care. Over the past decade, EHRs have increasingly offered opportunities to speed up, streamline, and enhance clinical research. EHRs offer a wide range of possible uses in clinical trials, including assisting with prestudy feasibility assessment, patient recruitment, and data capture in care delivery. To fully appreciate these opportunities, health care stakeholders must come together to face critical challenges in leveraging EHR data, including data quality/completeness, information security, stakeholder engagement, and increasing the scale of research infrastructure and related governance. Leaders from academia, government, industry, and professional societies representing patient, provider, researcher, industry, and regulator perspectives convened the Leveraging EHR for Clinical Research Now! Think Tank in Washington, DC (February 18-19, 2016), to identify barriers to using EHRs in clinical research and to generate potential solutions. Think tank members identified a broad range of issues surrounding the use of EHRs in research and proposed a variety of solutions. Recognizing the challenges, the participants identified the urgent need to look more deeply at previous efforts to use these data, share lessons learned, and develop a multidisciplinary agenda for best practices for using EHRs in clinical research. We report the proceedings from this think tank meeting in the following paper. Copyright © 2018 Elsevier, Inc. All rights reserved.

  3. Clinician-Reported Outcome Assessments of Treatment Benefit: Report of the ISPOR Clinical Outcome Assessment Emerging Good Practices Task Force.

    Science.gov (United States)

    Powers, John H; Patrick, Donald L; Walton, Marc K; Marquis, Patrick; Cano, Stefan; Hobart, Jeremy; Isaac, Maria; Vamvakas, Spiros; Slagle, Ashley; Molsen, Elizabeth; Burke, Laurie B

    2017-01-01

    A clinician-reported outcome (ClinRO) assessment is a type of clinical outcome assessment (COA). ClinRO assessments, like all COAs (patient-reported, observer-reported, or performance outcome assessments), are used to 1) measure patients' health status and 2) define end points that can be interpreted as treatment benefits of medical interventions on how patients feel, function, or survive in clinical trials. Like other COAs, ClinRO assessments can be influenced by human choices, judgment, or motivation. A ClinRO assessment is conducted and reported by a trained health care professional and requires specialized professional training to evaluate the patient's health status. This is the second of two reports by the ISPOR Clinical Outcomes Assessment-Emerging Good Practices for Outcomes Research Task Force. The first report provided an overview of COAs including definitions important for an understanding of COA measurement practices. This report focuses specifically on issues related to ClinRO assessments. In this report, we define three types of ClinRO assessments (readings, ratings, and clinician global assessments) and describe emerging good measurement practices in their development and evaluation. The good measurement practices include 1) defining the context of use; 2) identifying the concept of interest measured; 3) defining the intended treatment benefit on how patients feel, function, or survive reflected by the ClinRO assessment and evaluating the relationship between that intended treatment benefit and the concept of interest; 4) documenting content validity; 5) evaluating other measurement properties once content validity is established (including intra- and inter-rater reliability); 6) defining study objectives and end point(s) objectives, and defining study end points and placing study end points within the hierarchy of end points; 7) establishing interpretability in trial results; and 8) evaluating operational considerations for the implementation of

  4. Translational Bioinformatics and Clinical Research (Biomedical) Informatics.

    Science.gov (United States)

    Sirintrapun, S Joseph; Zehir, Ahmet; Syed, Aijazuddin; Gao, JianJiong; Schultz, Nikolaus; Cheng, Donavan T

    2015-06-01

    Translational bioinformatics and clinical research (biomedical) informatics are the primary domains related to informatics activities that support translational research. Translational bioinformatics focuses on computational techniques in genetics, molecular biology, and systems biology. Clinical research (biomedical) informatics involves the use of informatics in discovery and management of new knowledge relating to health and disease. This article details 3 projects that are hybrid applications of translational bioinformatics and clinical research (biomedical) informatics: The Cancer Genome Atlas, the cBioPortal for Cancer Genomics, and the Memorial Sloan Kettering Cancer Center clinical variants and results database, all designed to facilitate insights into cancer biology and clinical/therapeutic correlations. Copyright © 2015 Elsevier Inc. All rights reserved.

  5. Retooling Institutional Support Infrastructure for Clinical Research

    Science.gov (United States)

    Snyder, Denise C.; Brouwer, Rebecca N.; Ennis, Cory L.; Spangler, Lindsey L.; Ainsworth, Terry L.; Budinger, Susan; Mullen, Catherine; Hawley, Jeffrey; Uhlenbrauck, Gina; Stacy, Mark

    2016-01-01

    Clinical research activities at academic medical centers are challenging to oversee. Without effective research administration, a continually evolving set of regulatory and institutional requirements can detract investigator and study team attention away from a focus on scientific gain, study conduct, and patient safety. However, even when the need for research administration is recognized, there can be struggles over what form it should take. Central research administration may be viewed negatively, with individual groups preferring to maintain autonomy over processes. Conversely, a proliferation of individualized approaches across an institution can create inefficiencies or invite risk. This article describes experiences establishing a unified research support office at the Duke University School of Medicine based on a framework of customer support. The Duke Office of Clinical Research was formed in 2012 with a vision that research administration at academic medical centers should help clinical investigators navigate the complex research environment and operationalize research ideas. The office provides an array of services that have received high satisfaction ratings. The authors describe the ongoing culture change necessary for success of the unified research support office. Lessons learned from implementation of the Duke Office of Clinical Research may serve as a model for other institutions undergoing a transition to unified research support. PMID:27125563

  6. Good Research and Faculty Buy-in: 2 Keys to Effective Marketing

    Science.gov (United States)

    Blumenstyk, Goldie

    2008-01-01

    Effective marketing requires more than a sleek new logo. This article presents excerpts of an online discussion on the dos and don'ts of college marketing with Mary R. Stagaman, associate vice president for external relations at the University of Cincinnati. In this discussion, she noted that good research and faculty buy-in are the two keys to…

  7. CLARA: an integrated clinical research administration system

    Science.gov (United States)

    Bian, Jiang; Xie, Mengjun; Hogan, William; Hutchins, Laura; Topaloglu, Umit; Lane, Cheryl; Holland, Jennifer; Wells, Thomas

    2014-01-01

    Administration of human subject research is complex, involving not only the institutional review board but also many other regulatory and compliance entities within a research enterprise. Its efficiency has a direct and substantial impact on the conduct and management of clinical research. In this paper, we report on the Clinical Research Administration (CLARA) platform developed at the University of Arkansas for Medical Sciences. CLARA is a comprehensive web-based system that can streamline research administrative tasks such as submissions, reviews, and approval processes for both investigators and different review committees on a single integrated platform. CLARA not only helps investigators to meet regulatory requirements but also provides tools for managing other clinical research activities including budgeting, contracting, and participant schedule planning. PMID:24778201

  8. Radiopharmacy - clinical reality and selected research demands

    International Nuclear Information System (INIS)

    Hoer, G.

    2001-01-01

    My presentation aims at focusing on clinical reality of 18 F-fluorodeoxyglucose (FDG)-PET in three major medical specialities and to touch some of the demands in clinical PET research out of the sight of my view. Using of FDG in nuclear medicine is reviewed. (author)

  9. Implementing Clinical Research Using Factorial Designs: A Primer.

    Science.gov (United States)

    Baker, Timothy B; Smith, Stevens S; Bolt, Daniel M; Loh, Wei-Yin; Mermelstein, Robin; Fiore, Michael C; Piper, Megan E; Collins, Linda M

    2017-07-01

    Factorial experiments have rarely been used in the development or evaluation of clinical interventions. However, factorial designs offer advantages over randomized controlled trial designs, the latter being much more frequently used in such research. Factorial designs are highly efficient (permitting evaluation of multiple intervention components with good statistical power) and present the opportunity to detect interactions amongst intervention components. Such advantages have led methodologists to advocate for the greater use of factorial designs in research on clinical interventions (Collins, Dziak, & Li, 2009). However, researchers considering the use of such designs in clinical research face a series of choices that have consequential implications for the interpretability and value of the experimental results. These choices include: whether to use a factorial design, selection of the number and type of factors to include, how to address the compatibility of the different factors included, whether and how to avoid confounds between the type and number of interventions a participant receives, and how to interpret interactions. The use of factorial designs in clinical intervention research poses choices that differ from those typically considered in randomized clinical trial designs. However, the great information yield of the former encourages clinical researchers' increased and careful execution of such designs. Copyright © 2017. Published by Elsevier Ltd.

  10. Conducting Clinical Research Using Crowdsourced Convenience Samples.

    Science.gov (United States)

    Chandler, Jesse; Shapiro, Danielle

    2016-01-01

    Crowdsourcing has had a dramatic impact on the speed and scale at which scientific research can be conducted. Clinical scientists have particularly benefited from readily available research study participants and streamlined recruiting and payment systems afforded by Amazon Mechanical Turk (MTurk), a popular labor market for crowdsourcing workers. MTurk has been used in this capacity for more than five years. The popularity and novelty of the platform have spurred numerous methodological investigations, making it the most studied nonprobability sample available to researchers. This article summarizes what is known about MTurk sample composition and data quality with an emphasis on findings relevant to clinical psychological research. It then addresses methodological issues with using MTurk--many of which are common to other nonprobability samples but unfamiliar to clinical science researchers--and suggests concrete steps to avoid these issues or minimize their impact.

  11. Converging clinical and engineering research on neurorehabilitation

    CERN Document Server

    Torricelli, Diego; Pajaro, Marta

    2013-01-01

    Restoring human motor and cognitive function has been a fascinating research area during the last century. Interfacing the human nervous system with electro-mechanical rehabilitation machines is facing its crucial passage from research to clinical practice, enhancing the potentiality of therapists, clinicians and researchers to rehabilitate, diagnose and generate knowledge. The 2012 International Conference on Neurorehabilitation (ICNR2012, www.icnr2012.org) brings together researchers and students from the fields of Clinical Rehabilitation, Applied Neurophysiology and Biomedical Engineering, covering a wide range of research topics:   · Clinical Impact of Technology · Brain-Computer Interface in Rehabilitation · Neuromotor & Neurosensory modeling and processing · Biomechanics in Rehabilitation · Neural Prostheses in Rehabilitation · Neuro-Robotics in Rehabilitation · Neuromodulation   This Proceedings book includes general contributions from oral and poster sessions, as well as from special sess...

  12. Clinical trials: bringing research to the bedside.

    Science.gov (United States)

    Arvay, C A

    1991-02-01

    Over the years, clinical trials with their structured treatment plans and multicenter involvement have been instrumental in developing new treatments and establishing standard of care therapy. While clinical trials strive to advance medical knowledge, they provide scientifically sound, state of the art care and their use should be increased. The Brain Tumor Cooperative Group, one such NCI-sponsored cooperative group, has been the primary group for the treatment of malignant gliomas. As the field of neuro-oncology expands, the neuroscience nurse needs to develop an understanding of clinical trials and their operation. The nurse is in an optimal position to support medical research and the research participant.

  13. How will we know "good" qualitative research when we see it? Beginning the dialogue in health services research.

    Science.gov (United States)

    Devers, K J

    1999-12-01

    To lay the foundation for an explicit review and dialogue concerning the criteria that should be used to evaluate qualitative health services research. Clear criteria are critical for the discipline because they provide a benchmark against which research can be assessed. Existing literature in the social sciences and health services research, particularly in primary care and medicine. Traditional criteria for evaluating qualitative research are rooted in the philosophical perspective (positivism) most closely associated with quantitative research and methods. As a result, qualitative research and methods may not be used as frequently as they can be and research results generated from qualitative studies may not be disseminated as widely as possible. However, alternative criteria for evaluating qualitative research have been proposed that reflect a different philosophical perspective (post-positivism). Moreover, these criteria are tailored to the unique purposes for which qualitative research is used and the research designs traditionally employed. While criteria based on these two different philosophical perspectives have much in common, some important differences exist. The field of health services research must engage in a collective, "qualitative" process to determine which criteria to adopt (positivist or post-positivist), or whether some combination of the two is most appropriate. Greater clarity about the criteria used to evaluate qualitative research will strengthen the discipline by fostering a more appropriate and improved use of qualitative methods, a greater willingness to fund and publish "good" qualitative research, and the development of more informed consumers of qualitative research results.

  14. Research Issues in Clinical Data Warehousing

    DEFF Research Database (Denmark)

    Pedersen, Torben Bach; Jensen, Christian Søndergaard

    1998-01-01

    to data warehousing technologies, over those posed by conventional data warehouse applications. This article presents a number of exciting new research challenges posed by clinical applications, to be met by the database research community. These include the need for complex-data modeling features...

  15. [Conflict of interests in clinical research].

    Science.gov (United States)

    Alves, Elaine Maria de Oliveira; Tubino, Paulo

    2007-01-01

    In clinical research there is a real possibility to have some conflict of interests. Even for the researcher, the identification of these conflicts cannot be clear. There are many aspects to be considered, involving all participants of the process: the research subject, the researcher, the institution where the research is carried through, the sponsor, the ethics committees, the regulating agencies, the scientific community and the society. The conclusion is that conflicts of interests are common and inevitable in the academic field. The challenge is not to eradicate them, but to recognize them and to manage them properly. The only acceptable way to do this is to expose clearly the conflicts of interests and always to submit the clinical research projects to the ethics committees.

  16. Transitioning from Clinical to Qualitative Research Interviewing

    Directory of Open Access Journals (Sweden)

    Matthew R. Hunt BSc (PT, PhD

    2011-09-01

    Full Text Available In this paper one aspect of the transition that must be made by experienced clinicians who become involved in conducting qualitative health research is examined, specifically, the differences between clinical and research interviewing. A clinician who is skillful and comfortable carrying out a clinical interview may not initially apprehend the important differences between these categories and contexts of interviewing. This situation can lead to difficulties and diminished quality of data collection because the purpose, techniques and orientation of a qualitative research interview are distinct from those of the clinical interview. Appreciation of these differences between interview contexts and genres, and strategies for addressing challenges associated with these differences, can help clinician researchers to become successful qualitative interviewers.

  17. The Clinical Research Landscape in Rhode Island.

    Science.gov (United States)

    Mao, George; Ramratnam, Bharat

    2017-01-06

    To present an overview of clinical research activity and the state of medical research funding in Rhode Island. We utilized clinicaltrials.gov registry to profile clinical studies between 2011 to 2016. NIH RePORT and other federal databases were used to extract information on levels of federal funding. Previously published hospital financial reports were reviewed for data on hospital-specific total external research funding. During 2011-2016, 1651 clinical studies were registered in clinicaltrials.gov. Nearly a third of all clinical studies were in oncology (21%) and cardiovascular diseases (10%). Alzheimer's dementia, breast cancer, HIV, and hepatitis C accounted for nearly 17% of all clinical trials. Seventy-five percent (75%) of clinical trials in RI were conducted in hospitals affiliated with Lifespan or Care New England. Financial support for clinical trials largely came from industry (60%) with 23% being supported by the National Institutes of Health (NIH). The rest are funded by nonprofit organizations, charitable foundations, educational institutions, and unlisted concerns. [Full article available at http://rimed.org/rimedicaljournal-2017-01.asp].

  18. Electronic health records to facilitate clinical research.

    Science.gov (United States)

    Cowie, Martin R; Blomster, Juuso I; Curtis, Lesley H; Duclaux, Sylvie; Ford, Ian; Fritz, Fleur; Goldman, Samantha; Janmohamed, Salim; Kreuzer, Jörg; Leenay, Mark; Michel, Alexander; Ong, Seleen; Pell, Jill P; Southworth, Mary Ross; Stough, Wendy Gattis; Thoenes, Martin; Zannad, Faiez; Zalewski, Andrew

    2017-01-01

    Electronic health records (EHRs) provide opportunities to enhance patient care, embed performance measures in clinical practice, and facilitate clinical research. Concerns have been raised about the increasing recruitment challenges in trials, burdensome and obtrusive data collection, and uncertain generalizability of the results. Leveraging electronic health records to counterbalance these trends is an area of intense interest. The initial applications of electronic health records, as the primary data source is envisioned for observational studies, embedded pragmatic or post-marketing registry-based randomized studies, or comparative effectiveness studies. Advancing this approach to randomized clinical trials, electronic health records may potentially be used to assess study feasibility, to facilitate patient recruitment, and streamline data collection at baseline and follow-up. Ensuring data security and privacy, overcoming the challenges associated with linking diverse systems and maintaining infrastructure for repeat use of high quality data, are some of the challenges associated with using electronic health records in clinical research. Collaboration between academia, industry, regulatory bodies, policy makers, patients, and electronic health record vendors is critical for the greater use of electronic health records in clinical research. This manuscript identifies the key steps required to advance the role of electronic health records in cardiovascular clinical research.

  19. Clinical outcomes research in gynecologic oncology.

    Science.gov (United States)

    Melamed, Alexander; Rauh-Hain, J Alejandro; Schorge, John O

    2017-09-01

    Clinical outcomes research seeks to understand the real-world manifestations of clinical care. In particular, outcomes research seeks to reveal the effects of pharmaceutical, procedural, and structural aspects of healthcare on patient outcomes, including mortality, disease control, toxicity, cost, and quality of life. Although outcomes research can utilize interventional study designs, insightful use of observational data is a defining feature of this field. Many questions in gynecologic oncology are not amenable to investigation in randomized clinical trials due to cost, feasibility, or ethical concerns. When a randomized trial is not practical or has not yet been conducted, well-designed observational studies have the potential to provide the best available evidence about the effects of clinical care. Such studies may use surveys, medical records, disease registries, and a variety of administrative data sources. Even when a randomized trial has been conducted, observational studies can be used to estimate the real-world effect of an intervention, which may differ from the results obtained in the controlled setting of a clinical trial. This article reviews the goals, methodologies, data sources, and limitations of clinical outcomes research, with a focus on gynecologic oncology. Copyright © 2017. Published by Elsevier Inc.

  20. Ethics in clinical research: the Indian perspective.

    Science.gov (United States)

    Sanmukhani, J; Tripathi, C B

    2011-03-01

    Ethics in clinical research focuses largely on identifying and implementing the acceptable conditions for exposure of some individuals to risks and burdens for the benefit of society at large. Ethical guidelines for clinical research were formulated only after discovery of inhumane behaviour with participants during research experiments. The Nuremberg Code was the first international code laying ethical principles for clinical research. With increasing research all over, World Health Organization formulated guidelines in the form of Declaration of Helsinki in 1964. The US laid down its guidelines for ethical principles in the Belmont Report after discovery of the Tuskegee's Syphilis study. The Indian Council of Medical Research has laid down the 'Ethical Guidelines for Biomedical Research on Human Subjects' in the year 2000 which were revised in 2006. It gives twelve general principles to be followed by all biomedical researchers working in the country. The Ethics Committee stands as the bridge between the researcher and the ethical guidelines of the country. The basic responsibility of the Ethics Committee is to ensure an independent, competent and timely review of all ethical aspects of the project proposals received in order to safeguard the dignity, rights, safety and well-being of all actual or potential research participants. A well-documented informed consent process is the hallmark of any ethical research work. Informed consent respects individual's autonomy, to participate or not to participate in research. Concepts of vulnerable populations, therapeutic misconception and post trial access hold special importance in ethical conduct of research, especially in developing countries like India, where most of the research participants are uneducated and economically backward.

  1. THESEUS - a research project to improve the safety standard of tank vehicles for dangerous goods

    International Nuclear Information System (INIS)

    Guenther, B.

    1992-01-01

    A research project reffered to as THESEUS was initiated by the Federal Ministry of Research and Technology of Germany. The intent of the investigation is to generate measures designed to enhance the safety standard of commercial transports of dangerous goods in tank vehicles. Hereby, the analysis of real accidents by teams within the project will provide the relevant parameters for the experimental and theoretical investigation of vehicles, tank components and safety devices. The project started in summer 1990. This paper will focus main features and the work done so far. Special consideration will be made to the failure behaviour of tank components as the authors field of activity. (orig.)

  2. Reorganizing the General Clinical Research Center to improve the clinical and translational research enterprise.

    Science.gov (United States)

    Allen, David; Ripley, Elizabeth; Coe, Antoinette; Clore, John

    2013-12-01

    In 2010, Virginia Commonwealth University (VCU) was granted a Clinical and Translational Science Award which prompted reorganization and expansion of their clinical research infrastructure. A case study approach is used to describe the implementation of a business and cost recovery model for clinical and translational research and the transformation of VCU's General Clinical Research Center and Clinical Trials Office to a combined Clinical Research Services entity. We outline the use of a Plan, Do, Study, Act cycle that facilitated a thoughtful transition process, which included the identification of required changes and cost recovery processes for implementation. Through this process, the VCU Center for Clinical and Translational Research improved efficiency, increased revenue recovered, reduced costs, and brought a high level of fiscal responsibility through financial reporting.

  3. Regulation of clinical research and bioethics in Portugal.

    Science.gov (United States)

    Carvalho, Fatima Lampreia

    2007-06-01

    This article presents an overview of the Portuguese transposition of the European Directive on Good Clinical Practice (2001/20/E) concerning scientific and academic debates on bioethics and clinical investigation. Since the Directive was transposed into Portuguese law by its National Assembly, the bureaucracy of clinical trials has been ever more complex. Despite demands for swift application processes by the Pharmaceutical industry, supported by the European Parliament, the Directive's transcription to the national law has not always delivered the expected outcome. However, this has led to an increased number of applications for clinical trials in Portuguese hospitals. In this article I revise bioethical publications and decree-laws enabling an informed appraisal of the anxieties and prospects for the implementation of the clinical trials Directive in Portugal. This article also places the European Directive in the field of sociology of bioethics, arguing that Portuguese bioethical institutions differ from those of the US, and also from Northern European counterparts. The main divergence is that those people in Portugal who claim expertise in 'legal' bioethics do not dominate either the bureaucratic structure of research or ethics committees for health. Even experts in the applied ethics field now claim that 'professional bioethicists do not exist'. The recent creation of a national Ethics Committee for Clinical Investigation (CEIC) in line with the European Directive on Good Clinical Practice (GCP) will not change the present imbalance between different professional jurisdictions in the national bioethical debate in Portugal.

  4. Clinical Research Informatics Contributions from 2015.

    Science.gov (United States)

    Daniel, C; Choquet, R

    2016-11-10

    To summarize key contributions to current research in the field of Clinical Research Informatics (CRI) and to select best papers published in 2015. A bibliographic search using a combination of MeSH and free terms search over PubMed on Clinical Research Informatics (CRI) was performed followed by a double-blind review in order to select a list of candidate best papers to be then peer-reviewed by external reviewers. A consensus meeting between the two section editors and the editorial team was finally organized to conclude on the selection of best papers. Among the 579 returned papers published in the past year in the various areas of Clinical Research Informatics (CRI) - i) methods supporting clinical research, ii) data sharing and interoperability, iii) re-use of healthcare data for research, iv) patient recruitment and engagement, v) data privacy, security and regulatory issues and vi) policy and perspectives - the full review process selected four best papers. The first selected paper evaluates the capability of the Clinical Data Interchange Standards Consortium (CDISC) Operational Data Model (ODM) to support the representation of case report forms (in both the design stage and with patient level data) during a complete clinical study lifecycle. The second selected paper describes a prototype for secondary use of electronic health records data captured in non-standardized text. The third selected paper presents a privacy preserving electronic health record linkage tool and the last selected paper describes how big data use in US relies on access to health information governed by varying and often misunderstood legal requirements and ethical considerations. A major trend in the 2015 publications is the analysis of observational, "nonexperimental" information and the potential biases and confounding factors hidden in the data that will have to be carefully taken into account to validate new predictive models. In addiction, researchers have to understand

  5. Privacy protection and public goods: building a genetic database for health research in Newfoundland and Labrador.

    Science.gov (United States)

    Kosseim, Patricia; Pullman, Daryl; Perrot-Daley, Astrid; Hodgkinson, Kathy; Street, Catherine; Rahman, Proton

    2013-01-01

    To provide a legal and ethical analysis of some of the implementation challenges faced by the Population Therapeutics Research Group (PTRG) at Memorial University (Canada), in using genealogical information offered by individuals for its genetics research database. This paper describes the unique historical and genetic characteristics of the Newfoundland and Labrador founder population, which gave rise to the opportunity for PTRG to build the Newfoundland Genealogy Database containing digitized records of all pre-confederation (1949) census records of the Newfoundland founder population. In addition to building the database, PTRG has developed the Heritability Analytics Infrastructure, a data management structure that stores genotype, phenotype, and pedigree information in a single database, and custom linkage software (KINNECT) to perform pedigree linkages on the genealogy database. A newly adopted legal regimen in Newfoundland and Labrador is discussed. It incorporates health privacy legislation with a unique research ethics statute governing the composition and activities of research ethics boards and, for the first time in Canada, elevating the status of national research ethics guidelines into law. The discussion looks at this integration of legal and ethical principles which provides a flexible and seamless framework for balancing the privacy rights and welfare interests of individuals, families, and larger societies in the creation and use of research data infrastructures as public goods. The complementary legal and ethical frameworks that now coexist in Newfoundland and Labrador provide the legislative authority, ethical legitimacy, and practical flexibility needed to find a workable balance between privacy interests and public goods. Such an approach may also be instructive for other jurisdictions as they seek to construct and use biobanks and related research platforms for genetic research.

  6. Privacy protection and public goods: building a genetic database for health research in Newfoundland and Labrador

    Science.gov (United States)

    Pullman, Daryl; Perrot-Daley, Astrid; Hodgkinson, Kathy; Street, Catherine; Rahman, Proton

    2013-01-01

    Objective To provide a legal and ethical analysis of some of the implementation challenges faced by the Population Therapeutics Research Group (PTRG) at Memorial University (Canada), in using genealogical information offered by individuals for its genetics research database. Materials and methods This paper describes the unique historical and genetic characteristics of the Newfoundland and Labrador founder population, which gave rise to the opportunity for PTRG to build the Newfoundland Genealogy Database containing digitized records of all pre-confederation (1949) census records of the Newfoundland founder population. In addition to building the database, PTRG has developed the Heritability Analytics Infrastructure, a data management structure that stores genotype, phenotype, and pedigree information in a single database, and custom linkage software (KINNECT) to perform pedigree linkages on the genealogy database. Discussion A newly adopted legal regimen in Newfoundland and Labrador is discussed. It incorporates health privacy legislation with a unique research ethics statute governing the composition and activities of research ethics boards and, for the first time in Canada, elevating the status of national research ethics guidelines into law. The discussion looks at this integration of legal and ethical principles which provides a flexible and seamless framework for balancing the privacy rights and welfare interests of individuals, families, and larger societies in the creation and use of research data infrastructures as public goods. Conclusion The complementary legal and ethical frameworks that now coexist in Newfoundland and Labrador provide the legislative authority, ethical legitimacy, and practical flexibility needed to find a workable balance between privacy interests and public goods. Such an approach may also be instructive for other jurisdictions as they seek to construct and use biobanks and related research platforms for genetic research. PMID

  7. Role perceptions of nurse clinical research coordinators

    Directory of Open Access Journals (Sweden)

    Jones CT

    2013-09-01

    Full Text Available Carolynn Thomas Jones, Lynda L Wilson School of Nursing, University of Alabama at Birmingham, Birmingham, AL, USA Abstract: Nursing roles in clinical research have evolved in the last 3 decades and include diverse responsibilities and job titles. Nurse clinical research coordinators’ (NCRCs roles include study planning, implementation, participant recruitment and retention, assessment of participants’ responses to clinical protocols, data management, and evaluation. The purpose of this study was to examine NCRCs’ perceptions of 59 specific clinical research activities that have been proposed as a taxonomy of NCRC activities. Participants were asked to check whether each of the 59 activities is being performed, and whether those activities should be performed, by NCRCs. The sample included 61 NCRCs who were attending the annual meeting of the International Association of Clinical Research Nurses. The percentage of respondents who indicated that the 59 activities are being performed by NCRCs at their sites ranged from 55%–98.4%. The percentage of respondents who indicated that the 59 activities should be performed by NCRCs ranged from 61.7%–88.5%. There were eight activities that fewer than 70% of the respondents reported should be performed by NCRCs. Chi-square analyses were conducted to determine whether there was a difference in the distribution of responses to the “are performed” versus “should be performed” responses for each of the 59 activities. There were significant differences in the distributions for 49 of the activities. The percentage of nurses responding “are performed” was higher than the percentage of responses to the “should be performed” items for 41 of these 49 activities. Findings suggest that further research is needed to validate the extent to which the taxonomy of clinical research nurse (CRN roles is a valid reflection of the actual practice of NCRCs, and also to explore reasons for the

  8. Electronic health records to facilitate clinical research

    OpenAIRE

    Cowie, Martin R.; Blomster, Juuso I.; Curtis, Lesley H.; Duclaux, Sylvie; Ford, Ian; Fritz, Fleur; Goldman, Samantha; Janmohamed, Salim; Kreuzer, J?rg; Leenay, Mark; Michel, Alexander; Ong, Seleen; Pell, Jill P.; Southworth, Mary Ross; Stough, Wendy Gattis

    2016-01-01

    Electronic health records (EHRs) provide opportunities to enhance patient care, embed performance measures in clinical practice, and facilitate clinical research. Concerns have been raised about the increasing recruitment challenges in trials, burdensome and obtrusive data collection, and uncertain generalizability of the results. Leveraging electronic health records to counterbalance these trends is an area of intense interest. The initial applications of electronic health records, as the pr...

  9. Looking good or doing better? Patterns of decoupling in the implementation of clinical directorates.

    Science.gov (United States)

    Mascia, Daniele; Morandi, Federica; Cicchetti, Americo

    2014-01-01

    The interest toward hospital restructuring has risen significantly in recent years. In spite of its potential benefits, often organizational restructuring in health care produces unexpected consequences. Extant research suggests that institutional theory provides a powerful theoretical lens through which hospital restructuring can be described and explained. According to this perspective, the effectiveness of change is strongly related to the extent to which innovative arrangements, tools, or practices are adopted and implemented within hospitals. Whenever these new arrangements require a substantial modification of internal processes and practices, resistance to implementation emerges and organizational change is likely to become neutralized. This study analyzes how hospital organizations engage in decoupling by adopting but not implementing a new organizational model named clinical directorate. We collected primary data on the diffusion of the clinical directorate model, which was mandated by law in the Italian National Health Service to improve hospital services. We surveyed the adoption and implementation of the clinical directorate model by monitoring the presence of clinical governance tools (measures for the quality improvement of hospital services) within single directorates. In particular, we compared hospitals that adopted the model before (early adopters) or after (later adopters) the mandate was introduced. Hospitals were engaged in decoupling by adopting the new arrangement but not implementing internal practices and tools for quality improvement. The introduction of the law significantly affected the decoupling, with late-adopter hospitals being less likely to implement the adopted model. The present research shows that changes in quality improvement processes may vary in relation to policy makers' interventions aimed at boosting the adoption of new hospital arrangements. Hospital administrators need to be aware and identify the institutional changes

  10. Good Publication Practice for Communicating Company-Sponsored Medical Research: GPP3.

    Science.gov (United States)

    Battisti, Wendy P; Wager, Elizabeth; Baltzer, Lise; Bridges, Dan; Cairns, Angela; Carswell, Christopher I; Citrome, Leslie; Gurr, James A; Mooney, LaVerne A; Moore, B Jane; Peña, Teresa; Sanes-Miller, Carol H; Veitch, Keith; Woolley, Karen L; Yarker, Yvonne E

    2015-09-15

    This updated Good Publication Practice (GPP) guideline, known as GPP3, builds on earlier versions and provides recommendations for individuals and organizations that contribute to the publication of research results sponsored or supported by pharmaceutical, medical device, diagnostics, and biotechnology companies. The recommendations are designed to help individuals and organizations maintain ethical and transparent publication practices and comply with legal and regulatory requirements. These recommendations cover publications in peer-reviewed journals and presentations (oral or poster) at scientific congresses. The International Society for Medical Publication Professionals invited more than 3000 professionals worldwide to apply for a position on the steering committee, or as a reviewer, for this guideline. The GPP2 authors reviewed all applications (n = 241) and assembled an 18-member steering committee that represented 7 countries and a diversity of publication professions and institutions. From the 174 selected reviewers, 94 sent comments on the second draft, which steering committee members incorporated after discussion and consensus. The resulting guideline includes new sections (Principles of Good Publication Practice for Company-Sponsored Medical Research, Data Sharing, Studies That Should Be Published, and Plagiarism), expands guidance on the International Committee of Medical Journal Editors' authorship criteria and common authorship issues, improves clarity on appropriate author payment and reimbursement, and expands information on the role of medical writers. By following good publication practices (including GPP3), individuals and organizations will show integrity; accountability; and responsibility for accurate, complete, and transparent reporting in their publications and presentations.

  11. A checklist for health research priority setting: nine common themes of good practice

    Directory of Open Access Journals (Sweden)

    Terry Robert F

    2010-12-01

    Full Text Available Abstract Health research priority setting processes assist researchers and policymakers in effectively targeting research that has the greatest potential public health benefit. Many different approaches to health research prioritization exist, but there is no agreement on what might constitute best practice. Moreover, because of the many different contexts for which priorities can be set, attempting to produce one best practice is in fact not appropriate, as the optimal approach varies per exercise. Therefore, following a literature review and an analysis of health research priority setting exercises that were organized or coordinated by the World Health Organization since 2005, we propose a checklist for health research priority setting that allows for informed choices on different approaches and outlines nine common themes of good practice. It is intended to provide generic assistance for planning health research prioritization processes. The checklist explains what needs to be clarified in order to establish the context for which priorities are set; it reviews available approaches to health research priority setting; it offers discussions on stakeholder participation and information gathering; it sets out options for use of criteria and different methods for deciding upon priorities; and it emphasizes the importance of well-planned implementation, evaluation and transparency.

  12. A checklist for health research priority setting: nine common themes of good practice.

    Science.gov (United States)

    Viergever, Roderik F; Olifson, Sylvie; Ghaffar, Abdul; Terry, Robert F

    2010-12-15

    Health research priority setting processes assist researchers and policymakers in effectively targeting research that has the greatest potential public health benefit. Many different approaches to health research prioritization exist, but there is no agreement on what might constitute best practice. Moreover, because of the many different contexts for which priorities can be set, attempting to produce one best practice is in fact not appropriate, as the optimal approach varies per exercise. Therefore, following a literature review and an analysis of health research priority setting exercises that were organized or coordinated by the World Health Organization since 2005, we propose a checklist for health research priority setting that allows for informed choices on different approaches and outlines nine common themes of good practice. It is intended to provide generic assistance for planning health research prioritization processes. The checklist explains what needs to be clarified in order to establish the context for which priorities are set; it reviews available approaches to health research priority setting; it offers discussions on stakeholder participation and information gathering; it sets out options for use of criteria and different methods for deciding upon priorities; and it emphasizes the importance of well-planned implementation, evaluation and transparency.

  13. Beyond a good story: from Hawthorne Effect to reactivity in health professions education research.

    Science.gov (United States)

    Paradis, Elise; Sutkin, Gary

    2017-01-01

    Observational research is increasingly being used in health professions education (HPE) research, yet it is often criticised for being prone to observer effects (also known as the Hawthorne Effect), defined as a research participant's altered behaviour in response to being observed. This article explores this concern. First, this article briefly reviews the initial Hawthorne studies and the original formulation of the Hawthorne Effect, before turning to contemporary studies of the Hawthorne Effect in HPE and beyond. Second, using data from two observational studies (in the operating theatre and in the intensive care unit), this article investigates the Hawthorne Effect in HPE. Evidence of a Hawthorne Effect is scant, and amounts to little more than a good story. This is surprising given the foundational nature of the Hawthorne Studies in the social sciences and the prevalence of our concern with observer effects in HPE research. Moreover, the multiple and inconsistent uses of the Hawthorne Effect have left researchers without a coherent and helpful understanding of research participants' responses to observation. The authors' HPE research illustrates the complexity of observer effects in HPE, suggests that significant alteration of behaviour is unlikely in many research contexts, and shows how sustained contact with participants over time improves the quality of data collection. This article thus concludes with three recommendations: that researchers, editors and reviewers in the HPE community use the phrase 'participant reactivity' when considering the participant, observer and research question triad; that researchers invest in interpersonal relationships at their study site to mitigate the effects of altered behaviour; and that researchers use theory to make sense of participants' altered behaviour and use it as a window into the social world. The term 'participant reactivity' better reflects current scientific understandings of the research process and

  14. Heart Failure: From Research to Clinical Practice.

    Science.gov (United States)

    Islam, Md Shahidul

    2018-01-01

    "Heart failure: from research to clinical practice", a collection of selected reviews, which comes out also as a book, covers essentially all important aspects of heart failure, including the pathogenesis, clinical features, biomarkers, imaging techniques, medical treatment and surgical treatments, use of pacemakers and implantable cardioverter defibrillators, and palliative care. The reviews include essential background information, state of the art, critical and in-depth analysis, and directions for future researches for elucidation of the unresolved issues. Everyone interested in heart failure is expected to find this compilation helpful for a deeper understanding of some of the complex issues.

  15. Delivering the Goods: Scaling out Results of Natural Resource Management Research

    Directory of Open Access Journals (Sweden)

    Larry Harrington

    2002-01-01

    Full Text Available To help integrated natural resource management (INRM research "deliver the goods" for many of the world's poor over a large area and in a timely manner, the authors suggest a problem-solving approach that facilitates the scaling out of relevant agricultural practices. They propose seven ways to foster scaling out: (1 develop more attractive practices and technologies through participatory research (2 balance supply-driven approaches with resource user demands, (3 use feedback to redefine the research agenda, (4 encourage support groups and networks for information sharing, (5 facilitate negotiation among stakeholders, (6 inform policy change and institutional development, and (7 make sensible use of information management tools, including models and geographic information systems (GIS. They also draw on experiences in Mesoamerica, South Asia, and southern Africa to describe useful information management tools, including site similarity analyses, the linking of simulation models with GIS, and the use of farmer and land type categories.

  16. Trochleoplasty as a Solitary Treatment for Recurrent Patellar Dislocation Results in Good Clinical Outcome in Adolescents.

    Science.gov (United States)

    Camathias, Carlo; Studer, Katrin; Kiapour, Ata; Rutz, Erich; Vavken, Patrick

    2016-11-01

    The essential static patellar stabilizer is a normal-shaped trochlear groove. A dysplastic groove destabilizes the patella. Trochleoplasty approaches this underlying condition and reshapes the trochlea. However, studies have reported on trochleoplasty for revision cases or as accompanied by other interventions. The effect of trochleoplasty alone remains unexplained. To introduce trochleoplasty as a stand-alone treatment for recurrent patellar dislocation and to compare its pre- to postoperative functional and clinical variables. Case series; Level of evidence, 4. A trochleoplasty was performed in 50 knees (27 right) in 44 patients (30 females; mean ± SD age, 15.6 ± 2.0 years). The indication for surgery was recurrent patellar dislocation not responding to nonoperative treatment (>6 months), with types B through D dysplasia and closed or closing physes in adolescents aged 10 to 20 years. Assessment included J-sign and apprehension test, Kujala and Lysholm scores, patients' subjective assessment and activity level according to the International Knee Documentation Committee questionnaire, and patients' overall satisfaction. The Caton-Deschamps ratio and the lateral condyle index were measured. Pre- versus postoperative values were compared with a paired Wilcoxon signed-rank test. The minimum follow-up was 24 months (33 ± 10.6 months). The Kujala score improved from 71 preoperatively to 92 postoperatively (P debridement. In this study, trochleoplasty as a solitary treatment for recurrent patellofemoral dislocations in patients with trochlear dysplasia resulted in good clinical outcomes if severe torsional and axial malalignment was excluded. Kujala and Lysholm scores increased postoperatively, as well as subjective International Knee Documentation Committee assessment of outcomes, activity level, and overall satisfaction. © 2016 The Author(s).

  17. Budgeting, funding, and managing clinical research projects.

    Science.gov (United States)

    Hatfield, Elizabeth; Dicks, Elizabeth; Parfrey, Patrick

    2009-01-01

    Large, integrated multidisciplinary teams have become recognized as an efficient means by which to drive innovation and discovery in clinical research. This chapter describes how to budget and fund these large studies and effectively manage the large, often dispersed teams involved. Sources of funding are identified; budget development, justification, reporting, financial governance, and accountability are described; in addition to the creation and management of the multidisciplinary team that will implement the research plan.

  18. Blockchain technology for improving clinical research quality.

    Science.gov (United States)

    Benchoufi, Mehdi; Ravaud, Philippe

    2017-07-19

    Reproducibility, data sharing, personal data privacy concerns and patient enrolment in clinical trials are huge medical challenges for contemporary clinical research. A new technology, Blockchain, may be a key to addressing these challenges and should draw the attention of the whole clinical research community.Blockchain brings the Internet to its definitive decentralisation goal. The core principle of Blockchain is that any service relying on trusted third parties can be built in a transparent, decentralised, secure "trustless" manner at the top of the Blockchain (in fact, there is trust, but it is hardcoded in the Blockchain protocol via a complex cryptographic algorithm). Therefore, users have a high degree of control over and autonomy and trust of the data and its integrity. Blockchain allows for reaching a substantial level of historicity and inviolability of data for the whole document flow in a clinical trial. Hence, it ensures traceability, prevents a posteriori reconstruction and allows for securely automating the clinical trial through what are called Smart Contracts. At the same time, the technology ensures fine-grained control of the data, its security and its shareable parameters, for a single patient or group of patients or clinical trial stakeholders.In this commentary article, we explore the core functionalities of Blockchain applied to clinical trials and we illustrate concretely its general principle in the context of consent to a trial protocol. Trying to figure out the potential impact of Blockchain implementations in the setting of clinical trials will shed new light on how modern clinical trial methods could evolve and benefit from Blockchain technologies in order to tackle the aforementioned challenges.

  19. Team Science Approach to Developing Consensus on Research Good Practices for Practice-Based Research Networks: A Case Study.

    Science.gov (United States)

    Campbell-Voytal, Kimberly; Daly, Jeanette M; Nagykaldi, Zsolt J; Aspy, Cheryl B; Dolor, Rowena J; Fagnan, Lyle J; Levy, Barcey T; Palac, Hannah L; Michaels, LeAnn; Patterson, V Beth; Kano, Miria; Smith, Paul D; Sussman, Andrew L; Williams, Robert; Sterling, Pamela; O'Beirne, Maeve; Neale, Anne Victoria

    2015-12-01

    Using peer learning strategies, seven experienced PBRNs working in collaborative teams articulated procedures for PBRN Research Good Practices (PRGPs). The PRGPs is a PBRN-specific resource to facilitate PBRN management and staff training, to promote adherence to study protocols, and to increase validity and generalizability of study findings. This paper describes the team science processes which culminated in the PRGPs. Skilled facilitators used team science strategies and methods from the Technology of Participation (ToP®), and the Consensus Workshop Method to support teams to codify diverse research expertise in practice-based research. The participatory nature of "sense-making" moved through identifiable stages. Lessons learned include (1) team input into the scope of the final outcome proved vital to project relevance; (2) PBRNs with diverse domains of research expertise contributed broad knowledge on each topic; and (3) ToP® structured facilitation techniques were critical for establishing trust and clarifying the "sense-making" process. © 2015 Wiley Periodicals, Inc.

  20. Clinical Psychology and Research: epistemological notes

    Directory of Open Access Journals (Sweden)

    Emanuela Coppola

    2013-05-01

    Full Text Available The paper proposes a reflection on the relationship between clinical psychology and research, highlighting the constant epistemological crossing the two practices, empirical and professional. The paper warns against the pitfalls of reductionism that, in both cases, may impact the effectiveness of therapeutic results. In fact, both in clinical practice and is in psychological research, the mere application of techniques contradicts the specificity of the object of study (the mind which, rather, requires the constant attention to a complexity of variables and contextual elements essential for the understanding the psychic. Qualitative research has been a prolific space for dialogue and joint trials between research and clinical practice that has rehabilitated scientific dignity of affective and subjective for a long time confined to the ephemeral world of poetry and literature. It must therefore be a further extension of the convergence not only of qualitative and quantitative methods but also of training modules for researchers and practitioners are able to stimulate, in daily practice, confidence in the utility of scientific monitoring and detection of inter-subjective variables in research devices.

  1. Correlation between sonographic diagnosis and histopathological results ofgallbladder poliposis in Good Hope Clinic 2008-2014

    Directory of Open Access Journals (Sweden)

    Emiliano Contreras Castro

    2016-02-01

    Full Text Available Objective: To determine the correlation between sonographic diagnosis and histopathological results of gallbladder polyposis and find the positive predictive value of ultrasound in the diagnosis of this pathology. Material and Methods: It is a non experimental, transversal, descriptive and correlational study with a sample composed of all patients operated with a diagnosis of gallbladder polyps in the Good Hope Clinic between the years 2008 and 2014. A total of 128 patients were observed. Histopathological and sonographic reports of these patients were reviewed and the statistical correlation of both studies was sought by the test of Spearman. Results: Reveals that 67,2% were females and 32,8% were males; the average age was 43,4 years; 74,2% presented polyps by histopathological examination, of which 94,7% were pseudopolyps, with 82 % cases of cholesterolpolyps, only 5,3% were true polyps (adenomas and none of them were malignant. The positive predictive value of ultrasound in the diagnosis of gallbladder polyposis was 74,21%. According to the Spearman coefficient the correlation between the number of polyps by ultrasonography and histopathology was low, direct and significant (Rho = 0,189; p = 0,032. Conclusions: We conclude that there is a correlation between the ultrasound diagnosis and histopathological result of gallbladder polyps and ultrasound can be considered a reliable method for the diagnosis of gallbladder polyps.

  2. Current good manufacturing practice and investigational new drugs intended for use in clinical trials. Final rule.

    Science.gov (United States)

    2008-07-15

    The Food and Drug Administration (FDA) is amending the current good manufacturing practice (CGMP) regulations for human drugs, including biological products, to exempt most phase 1 investigational drugs from complying with the regulatory CGMP requirements. FDA will continue to exercise oversight of the manufacture of these drugs under FDA's general statutory CGMP authority and through review of the investigational new drug applications (IND). In addition, elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document entitled "Guidance for Industry: CGMP for Phase 1 Investigational Drugs" dated November 2007 (the companion guidance). This guidance document sets forth recommendations on approaches to compliance with statutory CGMP for the exempted phase 1 investigational drugs. FDA is taking this action to focus a manufacturer's effort on applying CGMP that is appropriate and meaningful for the manufacture of the earliest stage investigational drug products intended for use in phase 1 clinical trials while ensuring safety and quality. This action will also streamline and promote the drug development process.

  3. Action research methodology in clinical pharmacy

    DEFF Research Database (Denmark)

    Nørgaard, Lotte Stig; Sørensen, Ellen Westh

    2016-01-01

    Introduction The focus in clinical pharmacy practice is and has for the last 30-35 years been on changing the role of pharmacy staff into service orientation and patient counselling. One way of doing this is by involving staff in change process and as a researcher to take part in the change process...... by establishing partnerships with staff. On the background of the authors' widespread action research (AR)-based experiences, recommendations and comments for how to conduct an AR-study is described, and one of their AR-based studies illustrate the methodology and the research methods used. Methodology AR...... is defined as an approach to research which is based on a problem-solving relationship between researchers and clients, which aims at both solving a problem and at collaboratively generating new knowledge. Research questions relevant in AR-studies are: what was the working process in this change oriented...

  4. Guidelines for enhancing clinical supervision: research ...

    African Journals Online (AJOL)

    ... toesighouding behels, maar dat hulle nie die noodsaaklikheid om reflektiewe leer toe te pas tydens die proses van kliniese toesighouding aangedui het nie. Keywords: Clinical supervision, Reflective thinking and learning, Support, Guidance (Health SA Gesondheid: interdisciplinary research journal: 2003 8(4): 12-23) ...

  5. Random effects models in clinical research

    NARCIS (Netherlands)

    Cleophas, T. J.; Zwinderman, A. H.

    2008-01-01

    BACKGROUND: In clinical trials a fixed effects research model assumes that the patients selected for a specific treatment have the same true quantitative effect and that the differences observed are residual error. If, however, we have reasons to believe that certain patients respond differently

  6. The social value of clinical research.

    Science.gov (United States)

    Habets, Michelle G J L; van Delden, Johannes J M; Bredenoord, Annelien L

    2014-09-05

    International documents on ethical conduct in clinical research have in common the principle that potential harms to research participants must be proportional to anticipated benefits. The anticipated benefits that can justify human research consist of direct benefits to the research participant, and societal benefits, also called social value. In first-in-human research, no direct benefits are expected and the benefit component of the risks-benefit assessment thus merely exists in social value. The concept social value is ambiguous by nature and is used in numerous ways in the research ethics literature. Because social value justifies involving human participants, especially in early human trials, this is problematic. Our analysis and interpretation of the concept social value has led to three proposals. First, as no direct benefits are expected for the research participants in first-in-human trials, we believe it is better to discuss a risk- value assessment instead of a risk - benefit assessment. This will also make explicit the necessity to have a clear and common use for the concept social value. Second, to avoid confusion we propose to limit the concept social value to the intervention tested. It is the expected improvement the intervention can bring to the wellbeing of (future) patients or society that is referred to when we speak about social value. For the sole purpose of gaining knowledge, we should not expose humans to potential harm; the ultimate justification of involving humans in research lies in the anticipated social value of the intervention. Third, at the moment only the validity of the clinical research proposal is a prerequisite for research to take place. We recommend making the anticipated social value a prerequisite as well. In this paper we analyze the use of the concept social value in research ethics. Despite its unavoidable ambiguity, we aim to find a best use of the concept, subject to its role in justifying involving humans in first

  7. Prostate Cancer Clinical Consortium Clinical Research Site: Targeted Therapies

    Science.gov (United States)

    2016-10-01

    Physics of Cancer Metabolism This application seeks to put together a multidiscipline team of experts in various institutions in USA to assemble and...of this project is to build a research cohort of engaged volunteers that reflects the racial , ethnic, and socioeconomic diversity of New York City...assessed in a randomized, phase III clinical trial. Conflict of interest: Advisory Board: Joe O’Sullivan holds consulting/ advisory roles with Bayer

  8. What Does It Mean to Have an N of 1? Art Making, Education, Research, and the Public Good

    Science.gov (United States)

    Sullivan, Graeme

    2014-01-01

    In this special issue, each author addresses how ABER work connects with and/or directly addresses society's need/s and the public good as perceived by the researcher. As there are many construals of the "public good" and the relation to art-making and the arts to this "public good," each author will conceptualize her/his…

  9. 59th Clinical Research Division Research Day Briefing

    Science.gov (United States)

    2016-10-27

    College of Lab Animal Medicine; Certified by American College of Veterinary Pathology 1 - PhD, Physiology/Biochem - Clinical Research Admin...Molecular Biology/Genomics - Next Generation Sequencing - Real Time PCR - Multi-Plex Assays Cell Biology - Flow Cytometry Microbiology Coagulation

  10. Reengineering Clinical Research Science: A Focus on Translational Research

    Science.gov (United States)

    Ferrell, Courtney B.

    2009-01-01

    The burden of disease in the United States is high. Mental illness is currently the leading cause of disease burden among 15- to 44-year-olds. This phenomenon is occurring despite the many advances that have been made in clinical research. Several efficacious interventions are available to treat many of these disorders; however, they are greatly…

  11. Clinical Research Careers: Reports from a NHLBI Pediatric Heart Network Clinical Research Skills Development Conference

    Science.gov (United States)

    Lai, Wyman W.; Richmond, Marc; Li, Jennifer S.; Saul, J. Philip; Mital, Seema; Colan, Steven D.; Newburger, Jane W.; Sleeper, Lynn A.; McCrindle, Brain W.; Minich, L. LuAnn; Goldmuntz, Elizabeth; Marino, Bradley S.; Williams, Ismee A.; Pearson, Gail D.; Evans, Frank; Scott, Jane D.; Cohen, Meryl S.

    2013-01-01

    Background Wyman W. Lai, MD, MPH, and Victoria L. Vetter, MD, MPH. The Pediatric Heart Network (PHN), funded under the U.S. National Institutes of Health-National Heart, Lung, and Blood Institute (NIH–NHLBI), includes two Clinical Research Skills Development (CRSD) Cores, which were awarded to The Children's Hospital of Philadelphia and to the Morgan Stanley Children's Hospital of New York–Presbyterian. To provide information on how to develop a clinical research career to a larger number of potential young investigators in pediatric cardiology, the directors of these two CRSD Cores jointly organized a one-day seminar for fellows and junior faculty from all of the PHN Core sites. The participants included faculty members from the PHN and the NHLBI. The day-long seminar was held on April 29, 2009, at the NHLBI site, immediately preceding the PHN Steering Committee meeting in Bethesda, MD. Methods The goals of the seminar were 1) to provide fellows and early investigators with basic skills in clinical research 2) to provide a forum for discussion of important research career choices 3) to introduce attendees to each other and to established clinical researchers in pediatric cardiology, and 4) to publish a commentary on the future of clinical research in pediatric cardiology. Results The following chapters are compilations of the talks given at the 2009 PHN Clinical Research Skills Development Seminar, published to share the information provided with a broader audience of those interested in learning how to develop a clinical research career in pediatric cardiology. The discussions of types of clinical research, research skills, career development strategies, funding, and career management are applicable to research careers in other areas of clinical medicine as well. Conclusions The aim of this compilation is to stimulate those who might be interested in the research career options available to investigators. PMID:21167335

  12. Good Morning from Barrow, Alaska! Helping K-12 students understand the importance of research

    Science.gov (United States)

    Shelton, M.

    2010-12-01

    This presentation focuses on how an educator experiences scientific research and how those experiences can help foster K-12 students’ understanding of research being conducted in Barrow, Alaska. According to Zhang and Fulford (1994), real-time electronic field trips help to provide a sense of closeness and relevance. In combination with experts in the field, the electronic experience can help students to better understand the phenomenon being studied, thus strengthening the student’s conceptual knowledge (Zhang & Fulford, 1994). During a seven day research trip to study the arctic sea ice, five rural Virginia teachers and their students participated in Skype sessions with the participating educator and other members of the Radford University research team. The students were able to view the current conditions in Barrow, listen to members of the research team describe what their contributions were to the research, and ask questions about the research and Alaska in general. Collaborations between students and scientist can have long lasting benefits for both educators and students in promoting an understanding of the research process and understanding why our world is changing. By using multimedia venues such as Skype students are able to interact with researchers both visually and verbally, forming the basis for students’ interest in science. A learner’s level of engagement is affected by the use of multimedia, especially the level of cognitive processing. Visual images alone do no promote the development of good problem solving skills. However, the students are able to develop better problem solving skills when both visual images and verbal interactions are used together. As students form higher confidence levels by improving their ability to problem solve, their interest in science also increases. It is possible that this interest could turn into a passion for science, which could result in more students wanting to become scientists or science teachers.

  13. Good Practices for Water Quality Management in Research Reactors and Spent Fuel Storage Facilities

    International Nuclear Information System (INIS)

    2011-01-01

    Water is the most common fluid used to remove the heat produced in a research reactor (RR). It is also the most common media used to store spent fuel elements after being removed from the reactor core. Spent fuel is stored either in the at-reactor pool or in away-from-reactor wet facilities, where the fuel elements are maintained until submission to final disposal, or until the decay heat is low enough to allow migration to a dry storage facility. Maintaining high quality water is the most important factor in preventing degradation of aluminium clad fuel elements, and other structural components in water cooled research reactors. Excellent water quality in spent fuel wet storage facilities is essential to achieve optimum storage performance. Experience shows the remarkable success of many research reactors where the water chemistry has been well controlled. In these cases, aluminium clad fuel elements and aluminium pool liners show few, if any, signs of either localized or general corrosion, even after more than 30 years of exposure to research reactor water. In contrast, when water quality was allowed to degrade, the fuel clad and the structural parts of the reactor have been seriously corroded. The driving force to prepare this publication was the recognition that, even though a great deal of information on research reactor water quality is available in the open literature, no comprehensive report addressing the rationale of water quality management in research reactors has been published to date. This report is designed to provide a comprehensive catalogue of good practices for the management of water quality in research reactors. It also presents a brief description of the corrosion process that affects the components of a research reactor. Further, the report provides a basic understanding of water chemistry and its influence on the corrosion process; specifies requirements and operational limits for water purification systems of RRs; describes good practices

  14. Defining a Good Death (Successful Dying): Literature Review and a Call for Research and Public Dialogue.

    Science.gov (United States)

    Meier, Emily A; Gallegos, Jarred V; Thomas, Lori P Montross; Depp, Colin A; Irwin, Scott A; Jeste, Dilip V

    2016-04-01

    There is little agreement about what constitutes good death or successful dying. The authors conducted a literature search for published, English-language, peer-reviewed reports of qualitative and quantitative studies that provided a definition of a good death. Stakeholders in these articles included patients, prebereaved and bereaved family members, and healthcare providers (HCPs). Definitions found were categorized into core themes and subthemes, and the frequency of each theme was determined by stakeholder (patients, family, HCPs) perspectives. Thirty-six studies met eligibility criteria, with 50% of patient perspective articles including individuals over age 60 years. We identified 11 core themes of good death: preferences for a specific dying process, pain-free status, religiosity/spirituality, emotional well-being, life completion, treatment preferences, dignity, family, quality of life, relationship with HCP, and other. The top three themes across all stakeholder groups were preferences for dying process (94% of reports), pain-free status (81%), and emotional well-being (64%). However, some discrepancies among the respondent groups were noted in the core themes: Family perspectives included life completion (80%), quality of life (70%), dignity (70%), and presence of family (70%) more frequently than did patient perspectives regarding those items (35%-55% each). In contrast, religiosity/spirituality was reported somewhat more often in patient perspectives (65%) than in family perspectives (50%). Taking into account the limitations of the literature, further research is needed on the impact of divergent perspectives on end-of-life care. Dialogues among the stakeholders for each individual must occur to ensure a good death from the most critical viewpoint-the patient's. Copyright © 2016 American Association for Geriatric Psychiatry. Published by Elsevier Inc. All rights reserved.

  15. Economic theory and nursing administration research--is this a good combination?

    Science.gov (United States)

    Jones, Terry L; Yoder, Linda

    2010-01-01

    Economic theory is used to describe and explain decision making in the context of scarce resources. This paper presents two applications of economic theory to the delivery of nursing services in acute care hospitals and evaluates its usefulness in guiding nursing administration research. The description of economic theory and the proposed applications for nursing are based on current nursing, healthcare, and economic literature. Evaluation of the potential usefulness of economic theory in guiding nursing administration research is based on the criteria of significance and testability as described by Fawcett and Downs. While economic theory can be very useful in explaining how decisions about nursing time allocation and nursing care production are made, it will not address the issue of how they should be made. Normative theories and ethical frameworks also must be incorporated in the decision-making process around these issues. Economic theory and nursing administration are a good fit when balanced with the values and goals of nursing.

  16. Maintenance of Clinical Expertise and Clinical Research by the Clinical Professors at Gifu Pharmaceutical University.

    Science.gov (United States)

    Tachi, Tomoya; Noguchi, Yoshihiro; Teramachi, Hitomi

    2017-01-01

    The clinical professors at Gifu Pharmaceutical University (GPU) provide pharmaceutical services at GPU Pharmacy, Gifu University Hospital, and Gifu Municipal Hospital to keep their clinical skills up-to-date; they also perform clinical research in collaboration with many clinical institutes. The Laboratory of Clinical Pharmacy is part of the Department of Pharmacy Practice and Science, to which the clinical professors belong, and is composed of three clinical professors (a professor, an associate professor, and an assistant professor). The professor administers the GPU Pharmacy as its director, while the associate professor and assistant professor provide pharmaceutical services to patients at Gifu Municipal Hospital, and also provide practical training for students in the GPU Pharmacy. Collectively, they have performed research on such topics as medication education for students, clinical communication education, and analysis of clinical big data. They have also conducted research in collaboration with clinical institutes, hospitals, and pharmacies. Here, we introduce the collaborative research between the Laboratory of Clinical Pharmacy and Gifu Municipal Hospital. These studies include "Risk factors contributing to urinary protein expression resulting from bevacizumab combination chemotherapy", "Hyponatremia and hypokalemia as risk factors for falls", "Economic evaluation of adjustments of levofloxacin dosage by dispensing pharmacists for patients with renal dysfunction", and "Effect of patient education upon discharge for use of a medication notebook on purchasing over-the-counter drugs and health foods". In this symposium, we would like to demonstrate one model of the association and collaborative research between these clinical professors and clinical institutes.

  17. Unraveling Brazilian Indian population prostate good health: clinical, anthropometric and genetic features

    Directory of Open Access Journals (Sweden)

    Mario M. de Lima Junior

    2015-04-01

    Full Text Available Purpose To compare dietary, lifestyle, clinical, anthropometric, genetic and prostatic features of Brazilian Indians and non-Indians (Amazon. Methods 315 men, 228 Indians and 89 non-Indians, ≥40 years old were submitted to digital rectal examination, serum prostate specific antigen (PSA, testosterone, TP53 and GSTP1 genotyping, anthropometric, lifestyle, dietary, personal and familial medical history. Prostatic symptoms were evaluated with the International Prostate Symptom Score (IPSS. Results Macuxis and Yanomamis represented 43.6% and 14.5% of Indians respectively who spontaneously referred no prostate symptoms. Mean IPSS was 7, range 3-19, with only 15% of moderate symptoms (score 8-19; Mean age was 54.7 years, waist circumference 86.6 cm, BMI 23.9 kg/m2. Yanomamis presented both lower BMI (21.4 versus 24.8 and 23.3, p=0,001 and prostate volume than Macuxis and “other ethnic groups” (15 versus 20, p=0.001. Testosterone (414 versus 502 and 512, p=0.207 and PSA (0.48 versus 0.6 and 0.41, p=0.349 were similar with progressive PSA increase with aging. Val/Val correlated with lower PSA (p=0.0361. Indians compared to control population presented: - TP53 super representation of Arg/Arg haplotype, 74.5% versus 42.5%, p<0.0001. -GSTP1 Ile/Ile 35.3% versus 60.9%; Ile/Val 45.9% versus 28.7%; Val/Val 18.8% versus 10.3%; p=0.0003. Conclusions Observed specific dietary, lifestyle, anthropometric and genetic profile for TP53 and GSTP1 may contribute to Brazilian Indian population prostate good health.

  18. Unraveling Brazilian Indian population prostate good health: clinical, anthropometric and genetic features

    Science.gov (United States)

    de Lima, Mario M.; Reis, Leonardo O.; Ferreira, Ubirajara; Cardoso, Ulieme Oliveira; Barbieri, Raquel Bueno; de Mendonça, Gustavo B.; Ward, Laura S.

    2015-01-01

    Purpose To compare dietary, lifestyle, clinical, anthropometric, genetic and prostatic features of Brazilian Indians and non-Indians (Amazon). Methods 315 men, 228 Indians and 89 non-Indians, ≥40 years old were submitted to digital rectal examination, serum prostate specific antigen (PSA), testosterone, TP53 and GSTP1 genotyping, anthropometric, lifestyle, dietary, personal and familial medical history. Prostatic symptoms were evaluated with the International Prostate Symptom Score (IPSS). Results Macuxis and Yanomamis represented 43.6% and 14.5% of Indians respectively who spontaneously referred no prostate symptoms. Mean IPSS was 7, range 3-19, with only 15% of moderate symptoms (score 8-19); Mean age was 54.7 years, waist circumference 86.6 cm, BMI 23.9 kg/m2. Yanomamis presented both lower BMI (21.4 versus 24.8 and 23.3, p=0,001) and prostate volume than Macuxis and “other ethnic groups” (15 versus 20, p=0.001). Testosterone (414 versus 502 and 512, p=0.207) and PSA (0.48 versus 0.6 and 0.41, p=0.349) were similar with progressive PSA increase with aging. Val/Val correlated with lower PSA (p=0.0361). Indians compared to control population presented: - TP53 super representation of Arg/Arg haplotype, 74.5% versus 42.5%, p<0.0001. -GSTP1 Ile/Ile 35.3% versus 60.9%; Ile/Val 45.9% versus 28.7%; Val/Val 18.8% versus 10.3%; p=0.0003. Conclusions Observed specific dietary, lifestyle, anthropometric and genetic profile for TP53 and GSTP1 may contribute to Brazilian Indian population prostate good health. PMID:26005978

  19. 78 FR 20664 - Society of Clinical Research Associates-Food and Drug Administration: Food and Drug...

    Science.gov (United States)

    2013-04-05

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Society of Clinical Research Associates-Food and Drug Administration: Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good Clinical Practice AGENCY: Food and Drug...

  20. A research mentor training curriculum for clinical and translational researchers.

    Science.gov (United States)

    Pfund, Christine; House, Stephanie; Spencer, Kimberly; Asquith, Pamela; Carney, Paula; Masters, Kristyn S; McGee, Richard; Shanedling, Janet; Vecchiarelli, Stephanie; Fleming, Michael

    2013-02-01

    To design and evaluate a research mentor training curriculum for clinical and translational researchers. The resulting 8-hour curriculum was implemented as part of a national mentor training trial. The mentor training curriculum was implemented with 144 mentors at 16 academic institutions. Facilitators of the curriculum participated in a train-the-trainer workshop to ensure uniform delivery. The data used for this report were collected from participants during the training sessions through reflective writing, and following the last training session via confidential survey with a 94% response rate. A total of 88% of respondents reported high levels of satisfaction with the training experience, and 90% noted they would recommend the training to a colleague. Participants also reported significant learning gains across six mentoring competencies as well as specific impacts of the training on their mentoring practice. The data suggest the described research mentor training curriculum is an effective means of engaging research mentors to reflect upon and improve their research mentoring practices. The training resulted in high satisfaction, self-reported skill gains as well as behavioral changes of clinical and translational research mentors. Given success across 16 diverse sites, this training may serve as a national model. © 2012 Wiley Periodicals, Inc.

  1. Implementation of Good Clinical Laboratory Practice (GCLP) guidelines within the External Quality Assurance Program Oversight Laboratory (EQAPOL).

    Science.gov (United States)

    Todd, Christopher A; Sanchez, Ana M; Garcia, Ambrosia; Denny, Thomas N; Sarzotti-Kelsoe, Marcella

    2014-07-01

    The EQAPOL contract was awarded to Duke University to develop and manage global proficiency testing programs for flow cytometry-, ELISpot-, and Luminex bead-based assays (cytokine analytes), as well as create a genetically diverse panel of HIV-1 viral cultures to be made available to National Institutes of Health (NIH) researchers. As a part of this contract, EQAPOL was required to operate under Good Clinical Laboratory Practices (GCLP) that are traditionally used for laboratories conducting endpoint assays for human clinical trials. EQAPOL adapted these guidelines to the management of proficiency testing programs while simultaneously incorporating aspects of ISO/IEC 17043 which are specifically designed for external proficiency management. Over the first two years of the contract, the EQAPOL Oversight Laboratories received training, developed standard operating procedures and quality management practices, implemented strict quality control procedures for equipment, reagents, and documentation, and received audits from the EQAPOL Central Quality Assurance Unit. GCLP programs, such as EQAPOL, strengthen a laboratory's ability to perform critical assays and provide quality assessments of future potential vaccines. © 2013.

  2. Good practices of publishing AYUSH research: A practical checklist for authors

    Directory of Open Access Journals (Sweden)

    Kishor Patwardhan

    2017-04-01

    Full Text Available Since its inception, Journal of Ayurveda and Integrative Medicine (J-AIM has been constantly striving to create an environment that inculcates and strengthens “Good Publication Practices (GPP” amongst students, practitioners and researchers in AYUSH community. The J-AIM has been doing this in the form of conducting workshops on scientific writing and research methods on different platforms. This article is based on our experiences and varied discussions that we have had with students, teachers, practitioners and researchers during these interactive sessions, and is intended at addressing the gap that prevails in the domain. The need for such awareness is felt even more strongly ever since the Beall's list of predatory journals has been unpublished. This article tries to fill the void this disappearance has created. We analyze the current scenario of AYUSH publications, enumerate the common perceptions and concerns among the workers in the field, and consider the periodicals where the doctoral and postgraduate level of Ayurveda research works are being published at present. The article also presents a practical checklist that will be helpful for students and teachers to refer authentic resources and submit their work to an appropriate scholarly journal.

  3. Good practices of publishing AYUSH research: A practical checklist for authors.

    Science.gov (United States)

    Patwardhan, Kishor; Tillu, Girish; Jadhav, Priyanka M

    Since its inception, Journal of Ayurveda and Integrative Medicine (J-AIM) has been constantly striving to create an environment that inculcates and strengthens "Good Publication Practices (GPP)" amongst students, practitioners and researchers in AYUSH community. The J-AIM has been doing this in the form of conducting workshops on scientific writing and research methods on different platforms. This article is based on our experiences and varied discussions that we have had with students, teachers, practitioners and researchers during these interactive sessions, and is intended at addressing the gap that prevails in the domain. The need for such awareness is felt even more strongly ever since the Beall's list of predatory journals has been unpublished. This article tries to fill the void this disappearance has created. We analyze the current scenario of AYUSH publications, enumerate the common perceptions and concerns among the workers in the field, and consider the periodicals where the doctoral and postgraduate level of Ayurveda research works are being published at present. The article also presents a practical checklist that will be helpful for students and teachers to refer authentic resources and submit their work to an appropriate scholarly journal. Copyright © 2017 Transdisciplinary University, Bangalore and World Ayurveda Foundation. Published by Elsevier B.V. All rights reserved.

  4. Bringing ayahuasca to the clinical research laboratory.

    Science.gov (United States)

    Riba, Jordi; Barbanoj, Manel J

    2005-06-01

    Since the winter of 1999, the authors and their research team have been conducting clinical studies involving the administration of ayahuasca to healthy volunteers. The rationale for conducting this kind of research is twofold. First, the growing interest of many individuals for traditional indigenous practices involving the ingestion of natural psychotropic drugs such as ayahuasca demands the systematic study of their pharmacological profiles in the target species, i.e., human beings. The complex nature of ayahuasca brews combining a large number of pharmacologically active compounds requires that research be carried out to establish the safety and overall pharmacological profile of these products. Second, the authors believe that the study of psychedelics in general calls for renewed attention. Although the molecular and electrophysiological level effects of these drugs are relatively well characterized, current knowledge of the mechanisms by which these compounds modify the higher order cognitive processes in the way they do is still incomplete, to say the least. The present article describes the development of the research effort carried out at the Autonomous University of Barcelona, commenting on several methodological aspects and reviewing the basic clinical findings. It also describes the research currently underway in our laboratory, and briefly comments on two new studies we plan to undertake in order to further our knowledge of the pharmacology of ayahuasca.

  5. Current clinical research in orthodontics: a perspective.

    Science.gov (United States)

    Baumrind, Sheldon

    2006-10-01

    This essay explores briefly the approach of the Craniofacial Research Instrumentation Laboratory to the systematic and rigorous investigation of the usual outcome of orthodontic treatment in the practices of experienced clinicians. CRIL's goal is to produce a shareable electronic database of reliable, valid, and representative data on clinical practice as an aid in the production of an improved environment for truly evidence-based orthodontic treatment.

  6. Periprosthetic Joint Infections: Clinical and Bench Research

    Directory of Open Access Journals (Sweden)

    Laurence Legout

    2013-01-01

    Full Text Available Prosthetic joint infection is a devastating complication with high morbidity and substantial cost. The incidence is low but probably underestimated. Despite a significant basic and clinical research in this field, many questions concerning the definition of prosthetic infection as well the diagnosis and the management of these infections remained unanswered. We review the current literature about the new diagnostic methods, the management and the prevention of prosthetic joint infections.

  7. Negotiation skills for clinical research professionals

    Directory of Open Access Journals (Sweden)

    Sanjay Hake

    2011-01-01

    Full Text Available Negotiation as a skill is a key requirement for each and every job profile where dealing with multiple parties is involved. The important focus while negotiating should be on the interest then position. Key to every successful negotiation is advance planning, preparation, and patience as the objective is to create value and establish the terms on which parties with differing and often conflicting aims will co-operate. While preparing one should collect facts, know priorities, principles, identify common ground, decide on walk-away position, and try and identify the next best alternative. Negotiation is a set of skills that can be learned and practiced so that your ability to utilize relationship, knowledge, money, power, time, and personality to negotiate improves with each negotiation. In a successful negotiation, all parties win. Important thing to note is that not every negotiation involves money. Anytime you want something from someone else and anytime someone wants something from you, you are negotiating. Everything is negotiable and every day you negotiate with customers, suppliers, colleagues, your wife, and even your children. Negotiation is a game, and like any game it has its rules and tactics. Clinical Research professionals deal with various parties for different purposes at the same time; hence, they require excellent negotiation skills. Project Mangers and Clinical Research Associates are the two most important roles in clinical research industry who require negotiation skills as they deal with various internal and external customers and vendors.

  8. Negotiation skills for clinical research professionals

    Science.gov (United States)

    Hake, Sanjay; Shah, Tapankumar

    2011-01-01

    Negotiation as a skill is a key requirement for each and every job profile where dealing with multiple parties is involved. The important focus while negotiating should be on the interest then position. Key to every successful negotiation is advance planning, preparation, and patience as the objective is to create value and establish the terms on which parties with differing and often conflicting aims will co-operate. While preparing one should collect facts, know priorities, principles, identify common ground, decide on walk-away position, and try and identify the next best alternative. Negotiation is a set of skills that can be learned and practiced so that your ability to utilize relationship, knowledge, money, power, time, and personality to negotiate improves with each negotiation. In a successful negotiation, all parties win. Important thing to note is that not every negotiation involves money. Anytime you want something from someone else and anytime someone wants something from you, you are negotiating. Everything is negotiable and every day you negotiate with customers, suppliers, colleagues, your wife, and even your children. Negotiation is a game, and like any game it has its rules and tactics. Clinical Research professionals deal with various parties for different purposes at the same time; hence, they require excellent negotiation skills. Project Mangers and Clinical Research Associates are the two most important roles in clinical research industry who require negotiation skills as they deal with various internal and external customers and vendors. PMID:21897886

  9. Clinical Research Informatics: Supporting the Research Study Lifecycle.

    Science.gov (United States)

    Johnson, S B

    2017-08-01

    Objectives: The primary goal of this review is to summarize significant developments in the field of Clinical Research Informatics (CRI) over the years 2015-2016. The secondary goal is to contribute to a deeper understanding of CRI as a field, through the development of a strategy for searching and classifying CRI publications. Methods: A search strategy was developed to query the PubMed database, using medical subject headings to both select and exclude articles, and filtering publications by date and other characteristics. A manual review classified publications using stages in the "research study lifecycle", with key stages that include study definition, participant enrollment, data management, data analysis, and results dissemination. Results: The search strategy generated 510 publications. The manual classification identified 125 publications as relevant to CRI, which were classified into seven different stages of the research lifecycle, and one additional class that pertained to multiple stages, referring to general infrastructure or standards. Important cross-cutting themes included new applications of electronic media (Internet, social media, mobile devices), standardization of data and procedures, and increased automation through the use of data mining and big data methods. Conclusions: The review revealed increased interest and support for CRI in large-scale projects across institutions, regionally, nationally, and internationally. A search strategy based on medical subject headings can find many relevant papers, but a large number of non-relevant papers need to be detected using text words which pertain to closely related fields such as computational statistics and clinical informatics. The research lifecycle was useful as a classification scheme by highlighting the relevance to the users of clinical research informatics solutions. Georg Thieme Verlag KG Stuttgart.

  10. Nursing research. Components of a clinical research study.

    Science.gov (United States)

    Bargagliotti, L A

    1988-09-01

    Nursing research is the systematic collection and analysis of data about clinically important phenomena. While there are norms for conducting research and rules for using certain research procedures, the reader must always filter the research report against his or her nursing knowledge. The most common questions a reader should ask are "Does it make sense? Can I think of any other reasonable explanation for the findings? Do the findings fit what I have observed?" If the answers are reasonable, research findings from carefully conducted studies can provide a basis for making nursing decisions. One of the earliest accounts of nursing research, which indicates the power of making systematic observations, was Florence Nightingale's study. It compared deaths among soldiers in the Crimean War with deaths of soldiers in the barracks of London. Her research demonstrated that soldiers in the barracks had a much higher death rate than did the soldiers at war. On the basis of the study, sanitary conditions in the barracks were changed substantially.

  11. Using connected objects in clinical research.

    Science.gov (United States)

    Dhainaut, Jean-François; Huot, Laure; Pomar, Valérie Bouchara; Dubray, Claude

    2018-02-01

    Connected objects (CO), whether medical devices or not, are used in clinical research for data collection, a specific activity (communication, diagnosis, effector, etc.), or several functions combined. Their validation should be based on three approaches: technical and clinical reliability, data protection and cybersecurity. Consequently, the round table recommends that the typology of COs, their uses and limitations, be known and shared by all, particularly for implementing precise specifications. COs are used in clinical research during observational studies (assessment of the device itself or data collection), randomized studies, where only one group has a CO (assessment of its impact on patient follow-up or management), or randomized studies where both groups have a CO, which is then used as a tool to help with assessment. The benefits of using COs in clinical research includes: improved collection and quality of data, compliance of patients and pharmacovigilance, easier implementation of e-cohorts and a better representative balance of patients. The societal limits and risks identified relate to the sometimes intrusive nature of certain collected parameters and the possible misuse of data. The round table recommends the following on this last point: anticipation, by securing transmission methods, the qualification of data hosts, and assessment of the object's vulnerability. For this, a risk analysis appears necessary for each project. It is also necessary to accurately document the data flow, in order to inform both patients and healthcare professionals and to ensure adequate security. Anticipating regulatory changes and involving users starting from the study design stage are also recommended. Copyright © 2018 Société française de pharmacologie et de thérapeutique. Published by Elsevier Masson SAS. All rights reserved.

  12. Social phobia: research and clinical practice.

    Science.gov (United States)

    Alnaes, R

    2001-01-01

    Social phobia is a pervasive pattern of social inhibition, feelings of inadequacy, and hypersensitivity, occurring in about 18% of the clinical population. Despite good results with cognitive-behavioural treatment, social phobia seems to be a chronic disorder with several complications. The author describes an analysis of a divorced woman who was exposed to an early premature sexual seduction by her father, abruptly terminated because of an accident. The loss of the father was repaired by a delusional system as defence against the re-emergence of a catastrophic situation. Her compulsion to repeat the traumatic situation was seen in symbolic attempts to reproduce the lost experience of forbidden pleasure with other men, ending in hopeless affairs. According to DSM-IV the patient had-besides social phobia-several personality disturbances, clinically manifested by weak ego boundaries, an unclear identity, and low self-esteem. Cognitive-behavioural therapy and psychopharmaca were without any effect. The childhood experiences were repeated in the context of the analysis and worked through, especially the pre-oedipal and oedipal conflicts. Important repeating themes were "crime", guilt, and punishment. After 3 years of analysis it was possible for the patient to expose herself to anxiety-producing situations with less symptoms. It was possible for her to withdraw the projections and take more responsibility for the unconscious sexual and aggressive impulses. At the 5-year follow-up her satisfactions had become more realistic and she became involved in a positive relationship.

  13. [Alfredo Lanari, a clinical research style].

    Science.gov (United States)

    Romero, Lucía

    2012-01-01

    The institutionalization of clinical research in Argentina reached its point of greatest maturity with the creation, in 1957, of the Institute of Medical Investigations (Instituto de Investigaciones Médicas) of the Faculty of Medicine of the Universidad de Buenos Aires, and the drive of the man who was its director for almost 20 years, Alfredo Lanari. In this paper I analyze the ways in which he generated a style of clinical research and a referential position in local medical field that allowed him to carry out said institutional realization. This achievement was the result of a personal enterprise and at the same time part of a larger context of transformations within the medical discipline world-wide and at the Universidad de Buenos Aires. This study was carried out combining oral and documentary sources, such as interviews with physicians at the Institute of Medical Investigations, members of the journal Medicina and of the Argentine Society of Clinical Investigation (Sociedad Argentina de Investigación Clínica), as well as academic files and scientific articles.

  14. RETHINKING THE ROLE OF CLINICAL TRIAL DATA IN INTERNATIONAL INTELLECTUAL PROPERTY LAW: THE CASE FOR A PUBLIC GOODS APPROACH

    OpenAIRE

    REICHMAN, JEROME H.

    2009-01-01

    This article describes the growth and consequences of new intellectual property rights given to pharmaceutical developers, and it advocates treating clinical trials as a public good. Although the soaring cost of clinical trials is well known and discussed, too little attention is given to the underlying rationale for allowing drug developers to recoup their costs through the new intellectual property rights provided in multilateral, regional, and bilateral agreements. Known in the US as “mark...

  15. Consumer Right to Information before Purchase: Research on the Romanian Online Stores for Technical Consumer Goods

    Directory of Open Access Journals (Sweden)

    Carmen Balan

    2014-05-01

    Full Text Available The goal of the present paper is to evaluate the status of the protection of consumer right to information before the purchase from Romanian online stores. The perspective focuses on technical consumer goods. The research pursued two major objectives. The former consisted in analysing the compliance of the online stores with the provisions of article 6 paragraph 1 of the Directive 2011/83/EU on consumer rights, relative to the information provided to potential buyers before the purchase. The latter was to identify the consumer awareness of the rights stipulated by article 6 of the directive, as well as to study the opinions of consumers relative to the information that online stores are compelled to supply before purchase. The first objective was accomplished by applying the content analysis method to the information available on the Web for a sample of 100 online stores. The second objective was achieved through the survey method on a sample of 351 persons from the 25 to 34 age group, residing in Bucharest. Compared to other studies, the major contributions of the present research approach are the following: the investigation of an extensive sample of online stores; the wider range of products; the focus on both online stores and consumers. The results show that improvements are needed in the level of compliance and in the consumer awareness of own rights.

  16. Clinical Research Strategies for Fructose Metabolism12

    Science.gov (United States)

    Laughlin, Maren R.; Bantle, John P.; Havel, Peter J.; Parks, Elizabeth; Klurfeld, David M.; Teff, Karen; Maruvada, Padma

    2014-01-01

    Fructose and simple sugars are a substantial part of the western diet, and their influence on human health remains controversial. Clinical studies in fructose nutrition have proven very difficult to conduct and interpret. NIH and USDA sponsored a workshop on 13–14 November 2012, “Research Strategies for Fructose Metabolism,” to identify important scientific questions and parameters to be considered while designing clinical studies. Research is needed to ascertain whether there is an obesogenic role for fructose-containing sugars via effects on eating behavior and energy balance and whether there is a dose threshold beyond which these sugars promote progression toward diabetes and liver and cardiovascular disease, especially in susceptible populations. Studies tend to fall into 2 categories, and design criteria for each are described. Mechanistic studies are meant to validate observations made in animals or to elucidate the pathways of fructose metabolism in humans. These highly controlled studies often compare the pure monosaccharides glucose and fructose. Other studies are focused on clinically significant disease outcomes or health behaviors attributable to amounts of fructose-containing sugars typically found in the American diet. These are designed to test hypotheses generated from short-term mechanistic or epidemiologic studies and provide data for health policy. Discussion brought out the opinion that, although many mechanistic questions concerning the metabolism of monosaccharide sugars in humans remain to be addressed experimentally in small highly controlled studies, health outcomes research meant to inform health policy should use large, long-term studies using combinations of sugars found in the typical American diet rather than pure fructose or glucose. PMID:24829471

  17. Good leadership for good quality

    OpenAIRE

    Franzon, Vilma Maria

    2016-01-01

    Good leadership is important if you like to have high quality in the results. My experience in the production of the television industry is that conditions for good leadership is insufficient. Therefore, I have tried to get answers for those two questions in my exam report: What are the characteristics of good leadership? What are the prerequisites for good leadership out of production? The method I used is a literature study and observation. I have read a number of books and research studies...

  18. Frequent methodological errors in clinical research.

    Science.gov (United States)

    Silva Aycaguer, L C

    2018-03-07

    Several errors that are frequently present in clinical research are listed, discussed and illustrated. A distinction is made between what can be considered an "error" arising from ignorance or neglect, from what stems from a lack of integrity of researchers, although it is recognized and documented that it is not easy to establish when we are in a case and when in another. The work does not intend to make an exhaustive inventory of such problems, but focuses on those that, while frequent, are usually less evident or less marked in the various lists that have been published with this type of problems. It has been a decision to develop in detail the examples that illustrate the problems identified, instead of making a list of errors accompanied by an epidermal description of their characteristics. Copyright © 2018 Elsevier España, S.L.U. y SEMICYUC. All rights reserved.

  19. Science and the common good: indefinite, non-reviewable mandatory detention of asylum seekers and the research imperative.

    Science.gov (United States)

    Steel, Zachary; Silove, Derrick

    2004-10-01

    Despite a strong historical record of resettling and providing care for refugee populations, the Australian Federal Government has increasingly implemented harsh and restrictive policies regarding the treatment and management of asylum seekers. Most controversial of these has been the mandatory detention of asylum seekers, a policy applied indiscriminately and without discretion where individual cases have not been subject to judicial review or time constraints. From the outset health professionals have raised concerns about the possible adverse mental health impacts of prolonged detention. In contrast, government representatives have characterized conditions in detention as benign and comfortable, and have consistently contested criticism of detention, often citing a lack of scientific evidence as tacit support for the continuation of the policy. Nevertheless, requests for access to the detention centres to undertake rigorous scientific investigations have gone unheeded. In this context we argue that the Australian Government has failed to uphold its commitment to good governance by allowing transparency, openness and a willingness to have the impact of its policies scrutinized by scientists. The manifest conflict of interest in the government position leads to a breach in the normal social contract between mental health researchers and those responsible for the policy of detention. There is, we argue, a legitimate moral imperative in such situations for clinical researchers to breach the walls of enforced silence and give a voice to those who are afflicted. This imperative, however, must be carefully balanced against the risks that may face detainees agreeing to participate in such research.

  20. Variation of topical application to skin under good clinical practice (GCP)

    DEFF Research Database (Denmark)

    Vind-Kezunovic, Dina; Serup, Jørgen Vedelskov

    2016-01-01

    INTRODUCTION: Application of topical products by individuals is inherently variable and accurate dosing can be difficult to control. Variation of the dose used under optimal conditions in drug trials is unknown. METHODS: This trial was part of a double-blind, randomized, placebo-controlled good...

  1. Information technology for clinical, translational and comparative effectiveness research. Findings from the section clinical research informatics.

    Science.gov (United States)

    Daniel, C; Choquet, R

    2013-01-01

    To summarize advances of excellent current research in the new emerging field of Clinical Research Informatics. Synopsis of four key articles selected for the IMIA Yearbook 2013. The selection was performed by querying PubMed and Web of Science with predefined keywords. From the original set of 590 papers, a first subset of 461 articles which was in the scope of Clinical Research Informatics was refined into a second subset of 79 relevant articles from which 15 articles were retained for peer-review. The four selected articles exemplify current research efforts conducted in the areas of data representation and management in clinical trials, secondary use of EHR data for clinical research, information technology platforms for translational and comparative effectiveness research and implementation of privacy control. The selected articles not only illustrate how innovative information technology supports classically organized randomized controlled trials but also demonstrate that the long promised benefits of electronic health care data for research are becoming a reality through concrete platforms and projects.

  2. 'Good ethics and moral standing': a qualitative study of aesthetic leadership in clinical nursing practice.

    Science.gov (United States)

    Mannix, Judy; Wilkes, Lesley; Daly, John

    2015-06-01

    To explore how aesthetic leadership is embodied by clinical leaders in the nursing workplace. A number of different leadership styles have been developed, theorised and applied to the nursing workforce over the years. Many of these styles lack an explicit moral dimension in their identified leader attributes, due to a shift in theorising of leadership to focus on the impact of leader traits on followers. It is timely to look at aesthetic leadership, with its explicit moral dimension, as a way of improving outcomes for nurses, patients and health care organisations. Qualitative design, using conversation-style interviews with experienced registered nurses in designated clinical leadership roles. Twelve experienced registered nurses who worked in designated clinical leadership roles participated in an individual, digitally recorded, semi-structured conversation-style interview. Narrative data were transcribed and subject to thematic analysis. Three main themes emerged: 'True to their beliefs': embodying principled practice; 'Not all policies fit every patient': ethical leadership in ambiguous situations; and 'Being open to people's concerns': providing fair and just solutions. A strong moral compass shaped and guided participants' day-to-day clinical leadership activities. Participants provided a rich narrative on how aesthetic leadership is embodied in the clinical nursing setting. It was evident that their clinical leadership is shaped and guided by a strong moral compass. By incorporating into their practice an aesthetic world-view with its strong moral purpose, participants in this study have shown how aesthetic leadership can enhance the clinical nursing workplace. Nurses in the clinical setting value clinical leaders who embrace and operate with a strong moral compass. Aesthetic leadership, with its explicit strong moral purpose, offers a way of incorporating morality into clinical leadership in the nursing workplace. © 2015 John Wiley & Sons Ltd.

  3. Menstrual questionnaires for clinical and research use.

    Science.gov (United States)

    Matteson, Kristen A

    2017-04-01

    Patient-reported outcome measures (PROMs) have the potential to be extremely valuable in the clinical care delivery for women who report heavy menstrual bleeding (HMB). Increasingly, studies on HMB have incorporated PROMs to evaluate the impact of bleeding on quality of life. These measures have included semiquantitative charts and pictograms, questionnaires to assess symptoms and impact on quality of life, and health-related quality of life questionnaires. Recent systematic reviews have highlighted inconsistency of outcome measurement across studies on HMB as a challenge limiting the interpretability of the body of literature and the ability to generate consensus on the relative effectiveness of treatment options. Consequently, research initiatives and international collaborations are working to harmonize outcome measurement. Harmonizing the use of questionnaires in research and clinical care has the potential to improve patient-centered care delivery for women with HMB and improve the generation of patient-focused evidence-based guidelines for the evaluation and treatment of HMB. Copyright © 2016. Published by Elsevier Ltd.

  4. Good Practice Policy Framework for Energy Technology Research Development and Demonstration (RD and D)

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2011-07-01

    The transition to a low carbon economy clearly requires accelerating energy innovation and technology adoption. Governments have an important role in this context. They can help by establishing the enabling environment in which innovation can thrive, and within which effective and efficient policies can be identified, with the specific goal of advancing research, development, demonstration and, ultimately, deployment (RDD&D) of clean energy technologies. At the front end of the innovation process, significant increases in, and restructuring of, global RD&D efforts will be required, combined with well-targeted government RD&D policies. The development of a clear policy framework for energy technology RD&D, based on good practices, should include six elements: Coherent energy RD&D strategy and priorities; Adequate government RD&D funding and policy support; Co-ordinated energy RD&D governance; Strong collaborative approach, engaging industry through public private partnerships (PPPs); Effective RD&D monitoring and evaluation; and Strategic international collaboration. While countries have been favouring certain technologies over others, based on decisions on which areas are to receive funding, clear priorities are not always determined through structured analysis and documented processes. A review of stated energy RD&D priorities, based on announced technology programmes and strategies, and recent spending trends reveals some important deviations from stated priorities and actual RD&D funding.

  5. Good practice in the management of amyotrophic lateral sclerosis: clinical guidelines. An evidence-based review with good practice points. EALSC Working Group.

    Science.gov (United States)

    Andersen, Peter Munch; Borasio, Gian Domenico; Dengler, Reinhard; Hardiman, Orla; Kollewe, Katja; Leigh, Peter Nigel; Pradat, Pierre-Francois; Silani, Vincenzo; Tomik, Barbara

    2007-08-01

    The evidence base for diagnosis and management of ALS is still weak, and curative therapy is lacking. Nonetheless, early diagnosis and symptomatic therapy can profoundly influence care and quality of life of the patient and relatives, and may increase survival time. This review addresses the current optimal clinical approach to ALS. The literature search is complete to December 2006. Where there was lack of evidence but consensus was clear we have stated our opinion as good practice points. We conclude that a diagnosis of ALS can be achieved by early examination by an experienced neurologist. The patient should be informed of the diagnosis by the consultant. Following diagnosis, a multi-diciplinary care team should support the patient and relatives. Medication with riluzole should be initiated as early as possible. PEG is associated with improved nutrition and should be inserted early. The operation is hazardous in patients with VC <50%: RIG may be a better alternative. Non-invasive positive pressure ventilation improves survival and quality of life but is underused in Europe. Maintaining the patient's ability to communicate is essential. During the course of the disease, every effort should be made to maintain patient autonomy. Advance directives for palliative end of life care are important and should be discussed early with the patient and relatives if they so wish.

  6. 75 FR 51824 - Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good...

    Science.gov (United States)

    2010-08-23

    ... discussion include the following: (1) What FDA expects in a pharmaceutical clinical trial; (2) adverse event reporting--science, regulation, error, and safety; (3) Part 11 Compliance--Electronic signatures; (4...

  7. Coffee consumption, metabolic syndrome and clinical severity of psoriasis: good or bad stuff?

    Science.gov (United States)

    Barrea, Luigi; Muscogiuri, Giovanna; Di Somma, Carolina; Annunziata, Giuseppe; Megna, Matteo; Falco, Andrea; Balato, Anna; Colao, Annamaria; Savastano, Silvia

    2018-05-01

    Despite the wide consumption of coffee, its anti-inflammatory effect on clinical severity of psoriasis is still debatable. The aim of this study was to evaluate the association between the coffee consumption and clinical severity of psoriasis in a sample of patients stratified according to the presence of the metabolic syndrome (MetS) and smoking. This cross-sectional case-control observational study was conducted on 221 treatment-naïve psoriatic patients. Lifestyle habits, anthropometric measures, clinical and biochemical evaluations were obtained. Clinical severity of psoriasis was assessed by Psoriasis Area and Severity Index (PASI) score. Data on energy caloric intake and coffee consumption were collected using a 7-day food diary record. The coffee consumption was analyzed as coffee intake (consumers and non-consumers) and daily servings (range 0-4 servings/day). Coffee consumers have a lower PASI score vs non-consumers (p < 0.001). The lowest PASI score and MetS prevalence were found in patients consuming 3 cups of coffee/day (p < 0.001), which was also the most common daily serving (34.8%), whereas the highest PASI score was found among those drinking ≥ 4 cups/day. Grouping the case patients according to smoking and MetS, the best odds of PASI score was observed in those drinking 3 cups of coffee per day and no smokers, after adjusting for total energy intake (OR 74.8; p < 0.001). As a novel finding, we reported a negative association between coffee intake, MetS prevalence and clinical severity of psoriasis. The evaluation of the anti-inflammatory effect of coffee on clinical severity of psoriasis, whose metabolic risk increases along with its clinical severity, could be of great importance from a public health perspective.

  8. Chromosome 17 alterations identify good-risk and poor-risk tumors independently of clinical factors in medulloblastoma

    Science.gov (United States)

    McCabe, Martin G.; Bäcklund, L. Magnus; Leong, Hui Sun; Ichimura, Koichi; Collins, V. Peter

    2011-01-01

    Current risk stratification schemas for medulloblastoma, based on combinations of clinical variables and histotype, fail to accurately identify particularly good- and poor-risk tumors. Attempts have been made to improve discriminatory power by combining clinical variables with cytogenetic data. We report here a pooled analysis of all previous reports of chromosomal copy number related to survival data in medulloblastoma. We collated data from previous reports that explicitly quoted survival data and chromosomal copy number in medulloblastoma. We analyzed the relative prognostic significance of currently used clinical risk stratifiers and the chromosomal aberrations previously reported to correlate with survival. In the pooled dataset metastatic disease, incomplete tumor resection and severe anaplasia were associated with poor outcome, while young age at presentation was not prognostically significant. Of the chromosomal variables studied, isolated 17p loss and gain of 1q correlated with poor survival. Gain of 17q without associated loss of 17p showed a trend to improved outcome. The most commonly reported alteration, isodicentric chromosome 17, was not prognostically significant. Sequential multivariate models identified isolated 17p loss, isolated 17q gain, and 1q gain as independent prognostic factors. In a historical dataset, we have identified isolated 17p loss as a marker of poor outcome and 17q gain as a novel putative marker of good prognosis. Biological markers of poor-risk and good-risk tumors will be critical in stratifying treatment in future trials. Our findings should be prospectively validated independently in future clinical studies. PMID:21292688

  9. Glutamate in schizophrenia: clinical and research implications.

    Science.gov (United States)

    Goff, D C; Wine, L

    1997-10-30

    The excitatory amino acids, glutamate and aspartate, are of interest to schizophrenia research because of their roles in neurodevelopment, neurotoxicity and neurotransmission. Recent evidence suggests that densities of glutamatergic receptors and the ratios of subunits composing these receptors may be altered in schizophrenia, although it is unclear whether these changes are primary or compensatory. Agents acting at the phencyclidine binding site of the NMDA receptor produce symptoms of schizophrenia in normal subjects, and precipitate relapse in patients with schizophrenia. The improvement of negative symptoms with agents acting at the glycine modulatory site of the NMDA receptor, as well as preliminary evidence that clozapine may differ from conventional neuroleptic agents in its effects on glutamatergic systems, suggest that clinical implications may follow from this model. While geriatric patients may be at increased risk for glutamate-mediated neurotoxicity, very little is known about the specific relevance of this model to geriatric patients with schizophrenia.

  10. "It feels good to be measured": clinical role-play, Walker Percy, and the tingles.

    Science.gov (United States)

    Ahuja, Nitin K

    2013-01-01

    A large online community has recently formed around autonomous sensory meridian response (ASMR), a pleasant and poorly understood somatic reaction to specific interpersonal triggers. Its web-based manifestations include a variety of amateur videos designed to elicit the reaction, many of which feature protracted imitations of a clinician's physical exam. This analysis considers through a literary lens the proximity of this phenomenon to clinical diagnostics, focusing in particular on characterizations of spiritual isolation elaborated in Love in the Ruins (1971), the third novel by physician-writer Walker Percy (1916-1990). Within this speculative framework, the tendency to derive pleasure from clinical milieus, real or constructed, may be interpreted as a quality particular to the postmodern psyche. Viewing web-based clinical role-play in light of Percy's writing also underscores the possibility that routine diagnostic assessments may have independent therapeutic implications.

  11. Good clinical outcomes from a 7-year holistic programme of fistula repair in Guinea

    Science.gov (United States)

    Delamou, Alexandre; Diallo, Moustapha; Beavogui, Abdoul Habib; Delvaux, Thérèse; Millimono, Sita; Kourouma, Mamady; Beattie, Karen; Barone, Mark; Barry, Thierno Hamidou; Khogali, Mohamed; Edginton, Mary; Hinderaker, Sven Gudmund; Ruminjo, Joseph; Zhang, Wei-Hong; De Brouwere, Vincent

    2015-01-01

    Objectives Female genital fistula remains a public health concern in developing countries. From January 2007 to September 2013, the Fistula Care project, managed by EngenderHealth in partnership with the Ministry of Health and supported by USAID, integrated fistula repair services in the maternity wards of general hospitals in Guinea. The objective of this article was to present and discuss the clinical outcomes of 7 years of work involving 2116 women repaired in three hospitals across the country. Methods This was a retrospective cohort study using data abstracted from medical records for fistula repairs conducted from 2007 to 2013. The study data were reviewed during the period April to August 2014. Results The majority of the 2116 women who underwent surgical repair had vesicovaginal fistula (n = 2045, 97%) and 3% had rectovaginal fistula or a combination of both. Overall 1748 (83%) had a closed fistula and were continent of urine immediately after surgery. At discharge, 1795 women (85%) had a closed fistula and 1680 (79%) were dry, meaning they no longer leaked urine and/or faeces. One hundred and fifteen (5%) remained with residual incontinence despite fistula closure. Follow-up at 3 months was completed by 1663 (79%) women of whom 1405 (84.5%) had their fistula closed and 80% were continent. Twenty-one per cent were lost to follow-up. Conclusion Routine programmatic repair for obstetric fistula in low resources settings can yield good outcomes. However, more efforts are needed to address loss to follow-up, sustain the results and prevent the occurrence and/or recurrence of fistula. Objectifs La fistule génitale féminine reste un problème de santé publique dans les pays en développement. De janvier 2007 à septembre 2013, le projet Fistula Care, géré par Engender Health en partenariat avec le Ministère de la Santé et soutenu par l’USAID, a intégré les services de réparation de fistules dans les maternités des hôpitaux généraux en Guin

  12. Research nurse manager perceptions about research activities performed by non-nurse clinical research coordinators.

    Science.gov (United States)

    Jones, Carolynn Thomas; Hastings, Clare; Wilson, Lynda Law

    2015-01-01

    There has been limited research to document differences in roles between nurses and non-nurses who assume clinical research coordination and management roles. Several authors have suggested that there is no acknowledged guidance for the licensure requirements for research study coordinators and that some non-nurse research coordinators may be assuming roles that are outside of their legal scopes of practice. There is a need for further research on issues related to the delegation of clinical research activities to non-nurses. This study used nominal group process focus groups to identify perceptions of experienced research nurse managers at an academic health science center in the Southern United States about the clinical research activities that are being performed by non-nurse clinical research coordinators without supervision that they believed should only be performed by a nurse or under the supervision of a nurse. A total of 13 research nurse managers volunteered to be contacted about the study. Of those, 8 participated in two separate nominal group process focus group sessions. The group members initially identified 22 activities that they felt should only be performed by a nurse or under the direct supervision of a nurse. After discussion and clarification of results, activities were combined into 12 categories of clinical research activities that participants believed should only be performed by a nurse or under the direct supervision of a nurse. Copyright © 2015 Elsevier Inc. All rights reserved.

  13. Nurse leaders' perceptions of the ethical recruitment of study subjects in clinical research.

    Science.gov (United States)

    Nurmi, Sanna-Maria; Pietilä, Anna-Maija; Kangasniemi, Mari; Halkoaho, Arja

    2015-11-01

    The aim of this study was to describe nurse leaders' perceptions of ethical recruitment in clinical research. Nurse leaders are expected to get involved in clinical research, but there are few studies that focus on their role, particularly the ethical issues. Qualitative data were collected from ten nurse leaders using thematic one-to-one interviews and analysed with content analysis. Nurse leaders considered clinical research at their workplace in relation to the key issues that enabled ethical recruitment of study subjects in clinical research. These were: early information and collaboration for incorporating clinical research in everyday work, an opportune and peaceful recruitment moment and positive research culture. Getting involved in clinical research is part of the nurse leader's professional responsibility in current health care. They have an essential role to play in ensuring that recruitment is ethical and that the dignity of study subjects is maintained. The duty of nurse leaders is to maintain good contact with other collaborators and to ensure good conditions for implementing clinical research at their site. This requires a comprehensive understanding of the overall situation on their wards. Implementing clinical research requires careful planning, together with educating, supporting and motivating nursing staff. © 2014 John Wiley & Sons Ltd.

  14. 78 FR 28292 - Joint Biomedical Laboratory Research and Development and Clinical Science Research and...

    Science.gov (United States)

    2013-05-14

    ... DEPARTMENT OF VETERANS AFFAIRS Joint Biomedical Laboratory Research and Development and Clinical Science Research and Development Services Scientific Merit Review Board; Notice of Meetings; Amendment The... Joint Biomedical Laboratory Research and Development and Clinical Science Research and Development...

  15. Metapsychological and clinical issues in psychosomatics research.

    Science.gov (United States)

    Press, Jacques

    2016-02-01

    The author starts by treating the general epistemological problems inherent to research and emphasizes that all investigation takes place between two poles: a creative pole and one that is defensive in relation to the unknown and formlessness. In the psychosomatic field, an additional difficulty resides in the western dualistic vision of the relationship between psyche and soma which influences our way of thinking about the body as well as about otherness. The author continues by exploring Pierre Marty's psychosomatic model. Its psychosomatic monism is revolutionary but incomplete and creates a distance with the other, the somatizing patient, resulting in a medically oriented nosology symptomatic of the impossibility to think about some of the most important aspects of counter-transference. With the help of clinical material, the author considers these unthought aspects and some of their theoretical implications, particularly the way of understanding the negative often so prevalent with these patients. Based on these reflections as well as Freud's on beyond the pleasure principle and Winnicott's theorization on the fear of breakdown, the author suggests some directions for research. Somatic illness might occur when the attempts at filling the cracks created by a breakdown are unsuccessful. Copyright © 2015 Institute of Psychoanalysis.

  16. The Interpretative Phenomenological Analysis (IPA): A Guide to a Good Qualitative Research Approach

    Science.gov (United States)

    Alase, Abayomi

    2017-01-01

    As a research methodology, qualitative research method infuses an added advantage to the exploratory capability that researchers need to explore and investigate their research studies. Qualitative methodology allows researchers to advance and apply their interpersonal and subjectivity skills to their research exploratory processes. However, in a…

  17. Clinical audit of leg ulceration prevalence in a community area: a case study of good practice.

    Science.gov (United States)

    Hindley, Jenny

    2014-09-01

    This article presents the findings of an audit on venous leg ulceration prevalence in a community area as a framework for discussing the concept and importance of audit as a tool to inform practice and as a means to benchmark care against national or international standards. It is hoped that the discussed audit will practically demonstrate how such procedures can be implemented in practice for those who have not yet undertaken it, as well as highlighting the unexpected extra benefits of this type of qualitative data collection that can often unexpectedly inform practice and influence change. Audit can be used to measure, monitor and disseminate evidence-based practice across community localities, facilitating the identification of learning needs and the instigation of clinical change, thereby prioritising patient needs by ensuring safety through the benchmarking of clinical practice.

  18. Research and action: toward good quality of life and equity in health.

    Science.gov (United States)

    Schwartzmann, Laura

    2009-04-01

    A brief summary of key presentations at the 15th Annual International Society for Quality of Life conference is presented. Special highlights of this conference were its location (South America) and its aim to present current and potential contributions of the health-related quality of life (QoL) field to equity in healthcare at a clinical and population level, providing crucial inputs for decision-making in a person-centered health conception. Present and future utilization of health-related QoL measures, norms and bank items were introduced by David Cella, who also called for researchers' cooperation, stating that efforts towards a commonly shared language and metric are better than a relentless pursuit of perfection. Other central topics in the search of equity were stigma and poverty. The importance of negative attributes by others in stigma severity perception and low self-reported QoL was demonstrated by Donald Patrick, who suggested interventions for reducing stigma. Poverty impact on children's QoL and the importance of social determinants were demonstrated through a unique, longitudinal Brazilian study. Complementarily, the importance of a biological basis of oncologic symptoms, particularly cytokines, and the impact of their control on health-related QoL were addressed by Charles Cleeland. The meeting stressed the combined importance of social, psychological and biological factors in determining patient-reported outcomes.

  19. How novice, skilled and advanced clinical researchers include variables in a case report form for clinical research: a qualitative study.

    Science.gov (United States)

    Chu, Hongling; Zeng, Lin; Fetters, Micheal D; Li, Nan; Tao, Liyuan; Shi, Yanyan; Zhang, Hua; Wang, Xiaoxiao; Li, Fengwei; Zhao, Yiming

    2017-09-18

    Despite varying degrees in research training, most academic clinicians are expected to conduct clinical research. The objective of this research was to understand how clinical researchers of different skill levels include variables in a case report form for their clinical research. The setting for this research was a major academic institution in Beijing, China. The target population was clinical researchers with three levels of experience, namely, limited clinical research experience, clinicians with rich clinical research experience and clinical research experts. Using a qualitative approach, we conducted 13 individual interviews (face to face) and one group interview (n=4) with clinical researchers from June to September 2016. Based on maximum variation sampling to identify researchers with three levels of research experience: eight clinicians with limited clinical research experience, five clinicians with rich clinical research experience and four clinical research experts. These 17 researchers had diverse hospital-based medical specialties and or specialisation in clinical research. Our analysis yields a typology of three processes developing a case report form that varies according to research experience level. Novice clinician researchers often have an incomplete protocol or none at all, and conduct data collection and publication based on a general framework. Experienced clinician researchers include variables in the case report form based on previous experience with attention to including domains or items at risk for omission and by eliminating unnecessary variables. Expert researchers consider comprehensively in advance data collection and implementation needs and plan accordingly. These results illustrate increasing levels of sophistication in research planning that increase sophistication in selection for variables in the case report form. These findings suggest that novice and intermediate-level researchers could benefit by emulating the comprehensive

  20. Nurse awareness of clinical research: a survey in a Japanese University Hospital

    Science.gov (United States)

    2014-01-01

    Background Clinical research plays an important role in establishing new treatments and improving the quality of medical practice. Since the introduction of the concept of clinical research coordinators (CRC) in Japan, investigators and CRC work as a clinical research team that coordinates with other professionals in clinical trials leading to drug approval (registration trials). Although clinical nurses collaborate with clinical research teams, extended clinical research teams that include clinical nurses may contribute to the ethical and scientific pursuit of clinical research. Methods As knowledge of clinical research is essential for establishing an extended clinical research team, we used questionnaires to survey the knowledge of clinical nurses at Tokushima University Hospital. Five-point and two-point scales were used. Questions as for various experiences were also included and the relationship between awareness and experiences were analyzed. Results Among the 597 nurses at Tokushima University Hospital, 453 (75.9%) responded to the questionnaires. In Japan, registration trials are regulated by pharmaceutical affairs laws, whereas other types of investigator-initiated research (clinical research) are conducted based on ethical guidelines outlined by the ministries of Japan. Approximately 90% of respondents were aware of registration trials and clinical research, but less than 40% of the nurses were aware of their difference. In clinical research terminology, most respondents were aware of informed consent and related issues, but ≤50% were aware of other things, such as the Declaration of Helsinki, ethical guidelines, Good Clinical Practice, institutional review boards, and ethics committees. We found no specific tendency in the relationship between awareness and past experiences, such as nursing patients who were participating in registration trials and/or clinical research or taking a part in research involving patients as a nursing student or a nurse

  1. Clinical Trials: A Crucial Key to Human Health Research

    Science.gov (United States)

    ... Past Issues Clinical Trials: A Crucial Key to Human Health Research Past Issues / Summer 2006 Table of Contents ... Javascript on. Photo: PhotoDisc At the forefront of human health research today are clinical trials—studies that use ...

  2. Children's self reported discomforts as participants in clinical research.

    NARCIS (Netherlands)

    Staphorst, M.S.; Hunfeld, J.A.M.; van de Vathorst, S.; Passchier, J.; van Goudoever, J.B.

    2015-01-01

    Introduction: There is little empirical evidence on children's subjective experiences of discomfort during clinical research procedures. Therefore, Institutional Review Boards have limited empirical information to guide their decision-making on discomforts for children in clinical research. To get

  3. Children's self reported discomforts as participants in clinical research

    NARCIS (Netherlands)

    Staphorst, Mira S.; Hunfeld, Joke A. M.; van de Vathorst, Suzanne; Passchier, Jan; van Goudoever, Johannes B.

    2015-01-01

    There is little empirical evidence on children's subjective experiences of discomfort during clinical research procedures. Therefore, Institutional Review Boards have limited empirical information to guide their decision-making on discomforts for children in clinical research. To get more insight

  4. Clinical Research Nursing: Development of a Residency Program
.

    Science.gov (United States)

    Showalter, Brandi L; Cline, Debbie; Yungclas, Jan; Frentz, Kelly; Stafford, Susan R; Maresh, Kelly J

    2017-10-01

    Clinical research nurses are essential in the coordination of clinical trials and the management of research participants. Without a stable, knowledgeable research nurse workforce, the conduct of research is affected. A research nurse residency is a novel approach to preparing new graduate nurses for the oncology research nurse role. This article will describe the development and content of the research nurse residency and how this approach is being used to address a need for clinical research nurses to support burgeoning clinical trials at a National Cancer Institute-designated comprehensive cancer center.
.

  5. Report of the Task Force on Clinical Research in Dentistry.

    Science.gov (United States)

    Journal of Dental Education, 1994

    1994-01-01

    A report on clinical dental research reviews current conditions and makes recommendations for increased funding, improved peer review for research proposals, establishment of a well-defined training track for clinical researchers, and better institutional integration of and support for research and teaching. Projected need for researchers is also…

  6. Ethical Issues in Designing Internet-Based Research: Recommendations for Good Practice

    Science.gov (United States)

    Gupta, Shikha

    2017-01-01

    This article presents an overview of internet-based research, highlighting the absence of a standard terminology to define and classify such research. The label internet-based research or online research can cover a diverse range of research designs and methods, involving different degrees of ethical concern regarding privacy, transparency,…

  7. [Support Team for Investigator-Initiated Clinical Research].

    Science.gov (United States)

    Fujii, Hisako

    2017-07-01

    Investigator-initiated clinical research is that in which investigators plan and carry out their own clinical research in academia. For large-scale clinical research, a team should be organized and implemented. This team should include investigators and supporting staff, who will promote smooth research performance by fulfilling their respective roles. The supporting staff should include project managers, administrative personnel, billing personnel, data managers, and clinical research coordinators. In this article, I will present the current status of clinical research support and introduce the research organization of the Dominantly Inherited Alzheimer Network (DIAN) study, an investigator-initiated international clinical research study, with particular emphasis on the role of the project management staff and clinical research coordinators.

  8. Nutrition studies with human volunteers, designs and compliance to good clinical practice

    NARCIS (Netherlands)

    Schaafsma, G.

    2002-01-01

    In vitro experiments with cell cultures, studies with the TNO gastrointestinal model, animal experiments, and studies with human volunteers are used in nutrition research on the assessment of efficacy and safety of ingredients that can be used as bio actives in functional foods, functional drinks

  9. Feedback is good or bad? Medical residents’ points of view on feedback in clinical education

    Directory of Open Access Journals (Sweden)

    LEILA BAZRAFKAN

    2013-04-01

    Full Text Available Introduction: Feedback is very important in education and can help quality in the training process and orient the trainees in clinical contexts. This study aimed to assess the residents’ points of view about feedback in clinical education at Shiraz University of Medical Sciences. Methods: The sample of this study included 170 medical residents attending medical workshops in Shiraz University of Medical Sciences. The residents filled a valid and reliable questionnaire containing 21 items on their perceptions of the feedback they got throughout the workshops. The data were analyzed using SPSS version 14. Results: The study revealed that residents, generally, have a positive perception of feedback in their training. The highest score belonged to the items such as “feedback was applicable to future work”, “feedback corrected my behavior”, “feedback worked as a motivation for education” and “feedback was specific in one subject”. Residents who had a negative feedback experience also increased their efforts to learn. The Surgery residents acquired the highest scores while radiology residents got the lowest. The difference between these groups was statistically significant (P = 0.000. Conclusion: The highest mean score belonged to internal medicine residents. This shows that residents believe that obstetrics & gynecology ward is a ward in which the formative assessment is much more powerful in comparison to the other three major wards. The surgery ward received the lowest score for formative assessment and this shows that the feedback in surgery ward is very low.

  10. [Source data management in clinical researches].

    Science.gov (United States)

    Ho, Effie; Yao, Chen; Zhang, Zi-bao; Liu, Yu-xiu

    2015-11-01

    Source data and its source documents are the foundation of clinical research. Proper source data management plays an essential role for compliance with regulatory and GCP requirements. Both paper and electronic source data co-exist in China. Due to the increasing use of electronic technology in pharmaceutical and health care industry, electronic data source becomes an upcoming trend with clear advantages. To face new opportunities and to ensure data integrity, quality and traceability from source data to regulatory submission, this document demonstrates important concepts, principles and best practices during managing source data. It includes but not limited to: (1) important concepts of source data (e.g., source data originator, source data elements, source data identifier for audit trail, etc.); (2) various modalities of source data collection in paper and electronic methods (e.g., paper CRF, EDC, Patient Report Outcomes/eCOA, etc.); (3) seven main principles recommended in the aspect of data collection, traceability, quality standards, access control, quality control, certified copy and security during source data management; (4) a life cycle from source data creation to obsolete is used as an example to illustrate consideration and implementation of source data management.

  11. Strengthening maintenance and reconstruction of scientific experiment building and creating a good working environment for scientific research and production

    International Nuclear Information System (INIS)

    Fu Jianping

    2005-01-01

    The quality of scientific experiment building directly influences the scientific research work and production. To create a good working environment for scientific research and production, it is necessary to strengthen the maintenance and reconstruction for old scientific experiment building. The paper briefly introduces the site supervisory work of maintaining and reconstructing old scientific experiment building in Beijing Research Institute of Uranium Geology, as well as some measures taken to ensure the project quality, and the reconstructed building. (authors)

  12. Infant intersubjectivity: research, theory, and clinical applications.

    Science.gov (United States)

    Trevarthen, C; Aitken, K J

    2001-01-01

    We review research evidence on the emergence and development of active "self-and-other" awareness in infancy, and examine the importance of its motives and emotions to mental health practice with children. This relates to how communication begins and develops in infancy, how it influences the individual subject's movement, perception, and learning, and how the infant's biologically grounded self-regulation of internal state and self-conscious purposefulness is sustained through active engagement with sympathetic others. Mutual self-other-consciousness is found to play the lead role in developing a child's cooperative intelligence for cultural learning and language. A variety of preconceptions have animated rival research traditions investigating infant communication and cognition. We distinguish the concept of "intersubjectivity", and outline the history of its use in developmental research. The transforming body and brain of a human individual grows in active engagement with an environment of human factors--organic at first, then psychological or inter-mental. Adaptive, human-responsive processes are generated first by interneuronal activity within the developing brain as formation of the human embryo is regulated in a support-system of maternal tissues. Neural structures are further elaborated with the benefit of intra-uterine stimuli in the foetus, then supported in the rapidly growing forebrain and cerebellum of the young child by experience of the intuitive responses of parents and other human companions. We focus particularly on intrinsic patterns and processes in pre-natal and post-natal brain maturation that anticipate psychosocial support in infancy. The operation of an intrinsic motive formation (IMF) that developed in the core of the brain before birth is evident in the tightly integrated intermodal sensory-motor coordination of a newborn infant's orienting to stimuli and preferential learning of human signals, by the temporal coherence and intrinsic

  13. Guidelines and good clinical practice recommendations for Contrast Enhanced Ultrasound (CEUS) in the liver - update 2012

    DEFF Research Database (Denmark)

    Claudon, Michel; Dietrich, Christoph F; Choi, Byung Ihn

    2013-01-01

    Initially, a set of guidelines for the use of ultrasound contrast agents was published in 2004 dealing only with liver applications. A second edition of the guidelines in 2008 reflected changes in the available contrast agents and updated the guidelines for the liver, as well as implementing some...... Medizin/European Journal of Ultrasound for EFSUMB). These guidelines and recommendations provide general advice on the use of all currently clinically available ultrasound contrast agents (UCA). They are intended to create standard protocols for the use and administration of UCA in liver applications...... non-liver applications. Time has moved on, and the need for international guidelines on the use of CEUS in the liver has become apparent. The present document describes the third iteration of recommendations for the hepatic use of contrast enhanced ultrasound (CEUS) using contrast specific imaging...

  14. Research Universities: Producers of Economic Development or Luxury Goods? ASHE 1985 Annual Meeting Paper.

    Science.gov (United States)

    McClure, Maureen W.

    Research that occurs in universities under conditions of patronage is distinguished from research that occurs under less distorted market conditions. It is claimed that academic research is shifting from an area of patronage consumption to one of economic development investment. In addition to considering the markets for academic research and…

  15. Stewarding the Human Good: Understanding the Nature of Research and Its Ethical Horizons

    Science.gov (United States)

    Gabriele, Edward

    2012-01-01

    Research administration and leadership, above all, directly serve the needs of researchers, scientists, research programs, institutions and their leaders, and the public trust itself. Research administration is therefore an expansive and all encompassing profession. It integrates all of the diverse arts and sciences that are foundational to…

  16. The Interpretative Phenomenological Analysis (IPA: A Guide to a Good Qualitative Research Approach

    Directory of Open Access Journals (Sweden)

    Abayomi Alase

    2017-04-01

    Full Text Available As a research methodology, qualitative research method infuses an added advantage to the exploratory capability that researchers need to explore and investigate their research studies. Qualitative methodology allows researchers to advance and apply their interpersonal and subjectivity skills to their research exploratory processes. However, in a study with an interpretative phenomenological analysis (IPA approach, the advantageous elements of the study quadruple because of the bonding relationship that the approach allows for the researchers to develop with their research participants. Furthermore, as a qualitative research approach, IPA gives researchers the best opportunity to understand the innermost deliberation of the ‘lived experiences’ of research participants. As an approach that is ‘participant-oriented’, interpretative phenomenological analysis approach allows the interviewees (research participants to express themselves and their ‘lived experience’ stories the way they see fit without any distortion and/or prosecution. Therefore, utilizing the IPA approach in a qualitative research study reiterates the fact that its main objective and essence are to explore the ‘lived experiences’ of the research participants and allow them to narrate the research findings through their ‘lived experiences’. As such, this paper discusses the historical background of phenomenology as both a theory and a qualitative research approach, an approach that has transitioned into an interpretative analytical tradition. Furthermore, as a resource tool to novice qualitative researchers, this paper provides a step-by-step comprehensive guide to help prepare and equip researchers with ways to utilize and apply the IPA approach in their qualitative research studies.  More importantly, this paper also provides an advanced in-depth analysis and usability application for the IPA approach in a qualitatively conducted research study. As such, this

  17. Values Education as Good Practice Pedagogy: Evidence from Australian Empirical Research

    Science.gov (United States)

    Lovat, Terence

    2017-01-01

    This article focuses on the Australian Government's Values Education Program and, within its context, the "Values Education Good Practice Schools Project" (VEGPSP) Reports and the "Project to Test and Measure the Impact of Values Education on Student Effects and School Ambience," funded federally from 2003 to 2010. Findings…

  18. Years of research yield nothing, and that's good news for physicists

    CERN Multimedia

    Johnson, G

    2002-01-01

    Analysis of data from the Tevatron has so far not revealed the existence of supersymmetric particles. The results are good though because they establish a new lower limit for the mass of one of the hypothetical particles, a gluino (2 pages).

  19. Report on proton therapy according to good clinical practice at Hyogo Ion Beam Medical Center

    International Nuclear Information System (INIS)

    Murakami, Masao; Kagawa, Kazufumi; Hishikawa, Yoshio; Abe, Mitsuyuki

    2002-01-01

    The Hyogo Ion Beam Medical Center (HIBMC) is a hospital-based charged particle treatment facility. Having two treatment ion beams (proton and carbon) and five treatment rooms, it is a pioneer among particle institutes worldwide. In May 2001, proton therapy was started as a clinical study for patients with localized cancer originating in the head and neck, lung, liver, and prostate. The aim of this study was to investigate the safety, effectiveness, and stability of the treatment units and systems based on the evaluation of acute toxicity, tumor response, and working ratio of the machine, respectively. Six patients, including liver cancer in three, prostate cancer in two, and lung cancer in one, were treated. There was no cessation of therapy owing to machine malfunction. Full courses of proton therapy consisting of 154 portals in all six patients were given exactly as scheduled. None of the patients experienced severe acute reactions of more than grade 3 according to NCI-CTC criteria. Tumor response one month post-treatment was evaluable in five of the six patients, and was CR in 1 (prostate cancer), PR in 2 (lung cancer: 1, liver cancer: 1), and NC in 2 (liver cancer: 2). These results indicate that our treatment units and systems are safe and reliable enough for proton irradiation to be used for several malignant tumors localized in the body. (author)

  20. 77 FR 26069 - Joint Biomedical Laboratory Research and Development and Clinical Science Research and...

    Science.gov (United States)

    2012-05-02

    ... DEPARTMENT OF VETERANS AFFAIRS Joint Biomedical Laboratory Research and Development and Clinical Science Research and Development Services Scientific Merit Review Board, Notice of Meeting Amendment The... Development and Clinical Science Research and Development Services Scientific Merit Review Board have changed...

  1. Is operational research delivering the goods? The journey to success in low-income countries.

    Science.gov (United States)

    Zachariah, Rony; Ford, Nathan; Maher, Dermot; Bissell, Karen; Van den Bergh, Rafael; van den Boogaard, Wilma; Reid, Tony; Castro, Kenneth G; Draguez, Bertrand; von Schreeb, Johan; Chakaya, Jeremiah; Atun, Rifat; Lienhardt, Christian; Enarson, Don A; Harries, Anthony D

    2012-05-01

    Operational research in low-income countries has a key role in filling the gap between what we know from research and what we do with that knowledge-the so-called know-do gap, or implementation gap. Planned research that does not tangibly affect policies and practices is ineffective and wasteful, especially in settings where resources are scarce and disease burden is high. Clear parameters are urgently needed to measure and judge the success of operational research. We define operational research and its relation with policy and practice, identify why operational research might fail to affect policy and practice, and offer possible solutions to address these shortcomings. We also propose measures of success for operational research. Adoption and use of these measures could help to ensure that operational research better changes policy and practice and improves health-care delivery and disease programmes. Copyright © 2012 Elsevier Ltd. All rights reserved.

  2. Critical realism in supply chain research: Understanding the dynamics of a seasonal goods supply chain

    OpenAIRE

    Adamides, E. D.; Papachristos, G.; Pomonis, N.

    2012-01-01

    Purpose – The purpose of this paper is to show how a critical realist paradigmatic stance and its associated research methodology can contribute to supply‐chain research by providing explanations for specific supply‐chain‐ and logistics‐related dynamic phenomena. / Design/methodology/approach – Initially, the case for a critical realist research paradigm is made, and then a retroductive pluralistic research methodology is used for demonstrating its application. Starting from an observation in...

  3. Public Goods and Public Interests: Scholarly Communication and Government Documents in Research Libraries

    Science.gov (United States)

    Potvin, Sarah; Sare, Laura

    2016-01-01

    Federal mandates requiring that publicly funded research be made openly accessible recast scholarly information as public information and provide an impetus to join the efforts of scholarly communication and government information programs in United States research libraries. Most major research libraries are long-standing participants in the…

  4. Implementation of Good Laboratory Practices (GLP) in basic scientific research: Translating the concept beyond regulatory compliance.

    Science.gov (United States)

    Jena, G B; Chavan, Sapana

    2017-10-01

    The principles of Good Laboratory Practices (GLPs) are mainly intended for the laboratories performing studies for regulatory compliances. However, today GLP can be applied to broad disciplines of science to cater to the needs of the experimental objectives, generation of quality data and assay reproducibility. Considering its significance, it can now be applied in academics; industries as well as government set ups throughout the world. GLP is the best way to promote the reliability, reproducibility of the test data and hence facilitates the international acceptability. Now it is high time to translate and implement the concept of GLP beyond regulatory studies. Thus, it can pave the way for better understanding of scientific problems and help to maintain a good human and environmental health. Through this review, we have made an attempt to explore the uses of GLP principles in different fields of science and its acceptability as well as looking for its future perspectives. Copyright © 2017 Elsevier Inc. All rights reserved.

  5. Research Issues on Customer-Oriented and Eco-friendly Networks for Healthy Fashionable Goods

    OpenAIRE

    Fornasiero , Rosanna; Chiodi , Andrea; Carpanzano , Emanuele; Carneiro , Luis

    2010-01-01

    International audience; Needs and expectations of specific target groups - such as elderly, obese, disabled, or diabetic persons- are arising as challenging opportunities for European companies which are asked to supply small series of functional and fashionable goods of high quality, affordable price and eco-compatible. In order to design, develop, produce and distribute such products, a new framework and related components of collaborative networking need to be developed, enabling the produ...

  6. Your name is not good enough: introducing the ORCID researcher identifier at Imperial College London

    Directory of Open Access Journals (Sweden)

    Torsten Reimer

    2015-11-01

    Full Text Available The ORCID researcher identifier ensures that research outputs can always reliably be traced back to their authors. ORCID also makes it possible to automate the sharing of research information, thereby increasing data quality, reducing duplication of effort for academics and saving institutions money. In 2014, Imperial College London created ORCID identifiers (iDs for academic and research staff. This article discusses the implementation project in the context of the role of ORCID in the global scholarly communications system. It shows how ORCID can be used to automate reporting, help with research data publication and support open access (OA.

  7. Site Characteristics Influencing the Translation of Clinical Research Into Clinical Practice

    DEFF Research Database (Denmark)

    Smed, Marie; Getz, Kenneth A.

    2014-01-01

    Investigative sites participating in clinical trials play an instrumental role in aiding market adoption. Site experiences in clinical research help physician investigators and research professionals gain familiarity with and exposure to investigational treatments. This knowledge may be passed...

  8. For the Public Good: Research Impact and the Promise of Open Access

    OpenAIRE

    DePauw, Karen P.; Seyam, Mohammed; Roy, Siddhartha; Abbas, Montasir; Hole, Brian; Potter, Peter

    2016-01-01

    As a land-grant institution, Virginia Tech is committed to research that meaningfully engages with the vital concerns of our day such as feeding, building, and empowering a healthy world. How does Virginia Tech’s commitment to engagement fit with the Open Access vision for unrestricted online access to scholarly research? Have OA journals, public repositories, and federal mandates simply made a researcher’s life more complicated or could OA be the key to unlocking research impact on a global ...

  9. Promoting Positive Behavior Using the Good Behavior Game: A Meta-Analysis of Single-Case Research

    Science.gov (United States)

    Bowman-Perrott, Lisa; Burke, Mack D.; Zaini, Samar; Zhang, Nan; Vannest, Kimberly

    2016-01-01

    The Good Behavior Game (GBG) is a classroom management strategy that uses an interdependent group-oriented contingency to promote prosocial behavior and decrease problem behavior. This meta-analysis synthesized single-case research (SCR) on the GBG across 21 studies, representing 1,580 students in pre-kindergarten through Grade 12. The TauU effect…

  10. Applying the Seven Principles of Good Practice: Technology as a Lever--In an Online Research Course

    Science.gov (United States)

    Johnson, Sherryl

    2014-01-01

    This article provides an overview of the seven principles of good practice with emphasis on the implementation of technology in an online healthcare research class in a southwest Georgia (United States) university. The seven principles are outlined using various elements of the online course. Historical and philosophical reasoning are applied to…

  11. Is operational research delivering the goods? The journey to success in low-income countries

    OpenAIRE

    Zachariah, R; Ford, N; Maher, D; Bissell, K; Van den Bergh, R; van den Boogaard, W; Reid, T; Castro, K G; Draguez, B; von Schreeb, J; Chakaya, J; Atun, R; Lienhardt, C; Enarson, D A; Harries, A D

    2012-01-01

    Operational research in low-income countries has a key role in filling the gap between what we know from research and what we do with that knowledge-the so-called know-do gap, or implementation gap. Planned research that does not tangibly affect policies and practices is ineffective and wasteful, especially in settings where resources are scarce and disease burden is high. Clear parameters are urgently needed to measure and judge the success of operational research. We define operational rese...

  12. Functional MRI in children: clinical and research applications

    International Nuclear Information System (INIS)

    Leach, James L.; Holland, Scott K.

    2010-01-01

    Functional MRI has become a critical research tool for evaluating brain function and developmental trajectories in children. Its clinical use in children is becoming more common. This presentation will review the basic underlying physiologic and technical aspects of fMRI, review research applications that have direct clinical relevance, and outline the current clinical uses of this technology. (orig.)

  13. Non-clinical studies in the process of new drug development - Part II: Good laboratory practice, metabolism, pharmacokinetics, safety and dose translation to clinical studies.

    Science.gov (United States)

    Andrade, E L; Bento, A F; Cavalli, J; Oliveira, S K; Schwanke, R C; Siqueira, J M; Freitas, C S; Marcon, R; Calixto, J B

    2016-12-12

    The process of drug development involves non-clinical and clinical studies. Non-clinical studies are conducted using different protocols including animal studies, which mostly follow the Good Laboratory Practice (GLP) regulations. During the early pre-clinical development process, also known as Go/No-Go decision, a drug candidate needs to pass through several steps, such as determination of drug availability (studies on pharmacokinetics), absorption, distribution, metabolism and elimination (ADME) and preliminary studies that aim to investigate the candidate safety including genotoxicity, mutagenicity, safety pharmacology and general toxicology. These preliminary studies generally do not need to comply with GLP regulations. These studies aim at investigating the drug safety to obtain the first information about its tolerability in different systems that are relevant for further decisions. There are, however, other studies that should be performed according to GLP standards and are mandatory for the safe exposure to humans, such as repeated dose toxicity, genotoxicity and safety pharmacology. These studies must be conducted before the Investigational New Drug (IND) application. The package of non-clinical studies should cover all information needed for the safe transposition of drugs from animals to humans, generally based on the non-observed adverse effect level (NOAEL) obtained from general toxicity studies. After IND approval, other GLP experiments for the evaluation of chronic toxicity, reproductive and developmental toxicity, carcinogenicity and genotoxicity, are carried out during the clinical phase of development. However, the necessity of performing such studies depends on the new drug clinical application purpose.

  14. Good Pharma? How Business Communication Research Can Help Bridge the Gap between Students and Practitioners

    Science.gov (United States)

    Bruyer, Tom; Jacobs, Geert; Vandendaele, Astrid

    2016-01-01

    This article presents a case-based exploration of the complex interactions between learning, research, and practice in the field of business and professional communication. It focuses on a student research project in the area of corporate social responsibility in the biopharmaceutical industry. Adopting an autoethnographic approach, we aim to…

  15. The Social Dynamics of Art Research: Contemporary Photography in Belfast Post the Good Friday Agreement

    Science.gov (United States)

    Tuck, Sarah

    2014-01-01

    This article reflects critically on "The Social Dynamics of Art Research: Contemporary Photography in Belfast", an engaged research project conducted with photographers, community activists, academics and visual artists in Belfast. Through a critical examination of the project's theoretical architecture and methodological framework this…

  16. International market research at the Mayo Clinic.

    Science.gov (United States)

    Hathaway, M; Seltman, K

    2001-01-01

    Mayo Clinic has a long international history and has been providing care to international patients since its inception. Despite its history and reputation, however, the marketing staff continues to monitor the international market to gauge the level of awareness, reputation, and attractiveness of Mayo Clinic around the world. Here's a look at how one institution has used word-of-mouth marketing to maintain its global reputation.

  17. 76 FR 19188 - Joint Biomedical Laboratory Research and Development and Clinical Science Research and...

    Science.gov (United States)

    2011-04-06

    ... DEPARTMENT OF VETERANS AFFAIRS Joint Biomedical Laboratory Research and Development and Clinical... the panels of the Joint Biomedical Laboratory Research and Development and Clinical Science Research.... Neurobiology-D June 10, 2011 Crowne Plaza DC/Silver Spring. Clinical Research Program June 13, 2011 VA Central...

  18. 78 FR 66992 - Joint Biomedical Laboratory Research and Development and Clinical Science Research and...

    Science.gov (United States)

    2013-11-07

    ... DEPARTMENT OF VETERANS AFFAIRS Joint Biomedical Laboratory Research and Development and Clinical... the panels of the Joint Biomedical Laboratory Research and Development and Clinical Science Research..., behavioral, and clinical science research. The panel meetings will be open to the public for approximately...

  19. 75 FR 57833 - Joint Biomedical Laboratory Research and Development and Clinical Science Research and...

    Science.gov (United States)

    2010-09-22

    ... DEPARTMENT OF VETERANS AFFAIRS Joint Biomedical Laboratory Research and Development and Clinical... the panels of the Joint Biomedical Laboratory Research and Development and Clinical Science Research... Crowne Plaza Clinical Research Program December 3, 2010 *VA Central Office Mental Hlth & Behav Sci-A...

  20. 78 FR 22622 - Joint Biomedical Laboratory Research and Development and Clinical Science Research and...

    Science.gov (United States)

    2013-04-16

    ... DEPARTMENT OF VETERANS AFFAIRS Joint Biomedical Laboratory Research and Development and Clinical... the panels of the Joint Biomedical Laboratory Research and Development and Clinical Science Research... biomedical, behavioral and clinical science research. The panel meetings will be open to the public for...

  1. 75 FR 23847 - Joint Biomedical Laboratory Research and Development and Clinical Science Research and...

    Science.gov (United States)

    2010-05-04

    ... DEPARTMENT OF VETERANS AFFAIRS Joint Biomedical Laboratory Research and Development and Clinical... panels of the Joint Biomedical Laboratory Research and Development and Clinical Science Research and... & Behav Sci-A June 7, 2010 L'Enfant Plaza Hotel. Clinical Research Program June 9, 2010 *VA Central Office...

  2. How will we know "good" qualitative research when we see it? Beginning the dialogue in health services research.

    OpenAIRE

    Devers, K J

    1999-01-01

    OBJECTIVE: To lay the foundation for an explicit review and dialogue concerning the criteria that should be used to evaluate qualitative health services research. Clear criteria are critical for the discipline because they provide a benchmark against which research can be assessed. DATA SOURCES: Existing literature in the social sciences and health services research, particularly in primary care and medicine. PRINCIPAL FINDING: Traditional criteria for evaluating qualitative research are root...

  3. Are We Wasting a Good Crisis? The Availability of Psychological Research Data after the Storm

    Directory of Open Access Journals (Sweden)

    Wolf Vanpaemel

    2015-10-01

    Full Text Available To study the availability of psychological research data, we requested data from 394 papers, published in all issues of four APA journals in 2012. We found that 38% of the researchers sent their data immediately or after reminders. These findings are in line with estimates of the willingness to share data in psychology from the recent or remote past. Although the recent crisis of confidence that shook psychology has highlighted the importance of open research practices, and technical developments have greatly facilitated data sharing, our findings make clear that psychology is nowhere close to being an open science.

  4. The validity of the schizophrenia diagnosis in the Danish Psychiatric Central Research Register is good

    DEFF Research Database (Denmark)

    Uggerby, Peter; Østergaard, Søren Dinesen; Røge, Rasmus

    2013-01-01

    INTRODUCTION: The Danish Psychiatric Central Research Register (DPCRR) has been used extensively for research purposes during the past decades. The aim of this study was to investigate the validity of the International Classification of Diseases (ICD)-10 schizophrenia diagnosis in the DPCRR...... all 300 case records, the validity of the schizophrenia diagnosis was 89.7%. CONCLUSION: According to this assessment of patient case records, the diagnosis of schizophrenia in the DPCRR has a high validity and is well-suited for research. FUNDING: Aalborg Psychiatric Hospital funded the study...

  5. Highly effective cystic fibrosis clinical research teams: critical success factors.

    Science.gov (United States)

    Retsch-Bogart, George Z; Van Dalfsen, Jill M; Marshall, Bruce C; George, Cynthia; Pilewski, Joseph M; Nelson, Eugene C; Goss, Christopher H; Ramsey, Bonnie W

    2014-08-01

    Bringing new therapies to patients with rare diseases depends in part on optimizing clinical trial conduct through efficient study start-up processes and rapid enrollment. Suboptimal execution of clinical trials in academic medical centers not only results in high cost to institutions and sponsors, but also delays the availability of new therapies. Addressing the factors that contribute to poor outcomes requires novel, systematic approaches tailored to the institution and disease under study. To use clinical trial performance metrics data analysis to select high-performing cystic fibrosis (CF) clinical research teams and then identify factors contributing to their success. Mixed-methods research, including semi-structured qualitative interviews of high-performing research teams. CF research teams at nine clinical centers from the CF Foundation Therapeutics Development Network. Survey of site characteristics, direct observation of team meetings and facilities, and semi-structured interviews with clinical research team members and institutional program managers and leaders in clinical research. Critical success factors noted at all nine high-performing centers were: 1) strong leadership, 2) established and effective communication within the research team and with the clinical care team, and 3) adequate staff. Other frequent characteristics included a mature culture of research, customer service orientation in interactions with study participants, shared efficient processes, continuous process improvement activities, and a businesslike approach to clinical research. Clinical research metrics allowed identification of high-performing clinical research teams. Site visits identified several critical factors leading to highly successful teams that may help other clinical research teams improve clinical trial performance.

  6. Cultural humility: essential foundation for clinical researchers.

    Science.gov (United States)

    Yeager, Katherine A; Bauer-Wu, Susan

    2013-11-01

    Cultural humility is a process of self-reflection and discovery in order to build honest and trustworthy relationships. It offers promise for researchers to understand and eliminate health disparities, a continual and disturbing problem necessitating attention and action on many levels. This paper presents a discussion of the process of cultural humility and its important role in research to better understand the perspectives and context of the researcher and the research participant. We discern cultural humility from similar concepts, specifically cultural competence and reflexivity. We will also explore ways to cultivate cultural humility in the context of human subjects research. Mindfulness is one approach that can be helpful in enhancing awareness of self and others in this process. With a foundation in cultural humility, nurse researchers and other investigators can implement meaningful and ethical projects to better address health disparities. © 2013.

  7. Conducting research in clinical psychology practice: Barriers, facilitators, and recommendations.

    Science.gov (United States)

    Smith, Kirsten V; Thew, Graham R

    2017-09-01

    The combination of clinical psychologists' therapeutic expertise and research training means that they are in an ideal position to be conducting high-quality research projects. However, despite these skills and the documented benefits of research to services and service users, research activity in practice remains low. This article aims to give an overview of the advantages of, and difficulties in conducting research in clinical practice. We reviewed the relevant literature on barriers to research and reflected on our clinical and research experiences in a range of contexts to offer practical recommendations. We considered factors involved in the planning, sourcing support, implementation, and dissemination phases of research, and outline suggestions to improve the feasibility of research projects in post-qualification roles. We suggest that research leadership is particularly important within clinical psychology to ensure the profession's continued visibility and influence within health settings. Clinical implications Emerging evidence suggests that clinical settings that foster research are associated with better patient outcomes. Suggestions to increase the feasibility of research projects in clinical settings are detailed. Limitations The present recommendations are drawn from the authors' practical experience and may need adaptation to individual practitioners' settings. This study does not attempt to assess the efficacy of the strategies suggested. © 2017 The Authors. British Journal of Clinical Psychology published by John Wiley & Sons Ltd on behalf of British Psychological Society.

  8. How to design and write a clinical research protocol in Cosmetic Dermatology*

    Science.gov (United States)

    Bagatin, Ediléia; Miot, Helio A.

    2013-01-01

    Cosmetic Dermatology is a growing subspecialty. High-quality basic science studies have been published; however, few double-blind, randomized controlled clinical trials, which are the major instrument for evidence-based medicine, have been conducted in this area. Clinical research is essential for the discovery of new knowledge, improvement of scientific basis, resolution of challenges, and good clinical practice. Some basic principles for a successful researcher include interest, availability, persistence, and honesty. It is essential to learn how to write a protocol research and to know the international and national regulatory rules. A complete clinical trial protocol should include question, background, objectives, methodology (design, variable description, sample size, randomization, inclusion and exclusion criteria, intervention, efficacy and safety measures, and statistical analysis), consent form, clinical research form, and references. Institutional ethical review board approval and financial support disclosure are necessary. Publication of positive or negative results should be an authors' commitment. PMID:23539006

  9. Recent research and development in titanium alloys for biomedical applications and healthcare goods

    Directory of Open Access Journals (Sweden)

    Mitsuo Niinomi

    2003-01-01

    Full Text Available Nb, Ta and Zr are the favorable non-toxic alloying elements for titanium alloys for biomedical applications. Low rigidity titanium alloys composed of non-toxic elements are getting much attention. The advantage of low rigidity titanium alloy for the healing of bone fracture and the remodeling of bone is successfully proved by fracture model made in tibia of rabbit. Ni-free super elastic and shape memory titanium alloys for biomedical applications are energetically developed. Titanium alloys for not only implants, but also dental products like crowns, dentures, etc. are also getting much attention in dentistry. Development of investment materials suitable for titanium alloys with high melting point is desired in dental precision castings. Bioactive surface modifications of titanium alloys for biomedical applications are very important for achieving further developed biocompatibility. Low cost titanium alloys for healthcare goods, like general wheel chairs, etc. has been recently proposed.

  10. Barriers to Clinical Research in Latin America

    OpenAIRE

    Chomsky-Higgins, Kathryn; Miclau, Theodore A.; Mackechnie, Madeline C.; Aguilar, Dino; Avila, Jorge Rubio; dos Reis, Fernando Baldy; Balmaseda, Roberto; Barquet, Antonio; Ceballos, Alfredo; Contreras, Fernando; Escalante, Igor; Elias, Nelson; Vincenti, Sergio Iriarte; Lozano, Christian; Medina, Fryda

    2017-01-01

    Enhancing health research capacity in developing countries is a global health priority. Understanding the orthopedic burden of disease in Latin America will require close partnership between more-developed and less-developed countries. To this end, the Osteosynthesis and Trauma Care Foundation assembled a research consortium of Latin-American orthopedic leaders. Prior to the meeting, we surveyed attendees on perceived barriers to conducting research at their institutions. During the event, wo...

  11. Ensuring rigour and trustworthiness of qualitative research in clinical pharmacy.

    Science.gov (United States)

    Hadi, Muhammad Abdul; José Closs, S

    2016-06-01

    The use of qualitative research methodology is well established for data generation within healthcare research generally and clinical pharmacy research specifically. In the past, qualitative research methodology has been criticized for lacking rigour, transparency, justification of data collection and analysis methods being used, and hence the integrity of findings. Demonstrating rigour in qualitative studies is essential so that the research findings have the "integrity" to make an impact on practice, policy or both. Unlike other healthcare disciplines, the issue of "quality" of qualitative research has not been discussed much in the clinical pharmacy discipline. The aim of this paper is to highlight the importance of rigour in qualitative research, present different philosophical standpoints on the issue of quality in qualitative research and to discuss briefly strategies to ensure rigour in qualitative research. Finally, a mini review of recent research is presented to illustrate the strategies reported by clinical pharmacy researchers to ensure rigour in their qualitative research studies.

  12. Hypofractionated stereotactic irradiation. Basic and clinical researches

    International Nuclear Information System (INIS)

    Shibamoto, Yuta; Miyakawa, Akifumi; Iwata, Hiromitsu; Otsuka, Shinya; Ogino, Hiroyuki; Ayakawa, Shiho

    2011-01-01

    Hypofractionated stereotactic radiotherapy (SRT) has a number of biological advantages over single-session radiosurgery. An apparent trend is seen in the clinic towards shift from the latter to the former; however, there is no adequate model to convert single doses to hypofractionated doses. The linear-quadratic model overestimates the effect of single-fraction radiation. This should be kept in mind in evaluating the doses of stereotactic irradiation. ''Biological effective dose'' should not be used in radiosurgery and hypofractionated SRT. Clinically, we have used 3- to 10-fraction SRT for acoustic neuroma and benign skull base tumors using cyberknife and tomotherapy. Preliminary results are encouraging. (author)

  13. International Partnerships for Clinical Cancer Research

    Science.gov (United States)

    CGH co-sponsors the 2015 International Symposium on Cancer Clinical Trials and related meetings held in partnership with the Japanese National Cancer Center (JNCC) and Embassies of France, Korea, United Kingdom (UK), and United States (US) in Tokyo on May 14 - 15, 2015.

  14. The clinical applicability of music therapy research

    DEFF Research Database (Denmark)

    Wigram, Anthony Lewis

    in lengthy and complex theses is seldom accessible to the practitioner working ‘at the coal-face’; and sometimes lacks clear direction on how the results are applicable in everyday therapy. For results to be implemented in clinical practice and disseminated to colleagues in related fields as well as senior...

  15. [Clinical research XXIV. From clinical judgment to ethics in research on humans].

    Science.gov (United States)

    Pérez-Rodríguez, Marcela; Palacios-Cruz, Lino; Rivas-Ruiz, Rodolfo; Talavera, Juan O

    2014-01-01

    Bioethics in research is an essential part of the structured review process of an article and it is based on three fundamental principles: respect for persons, beneficence and justice. In addition to not providing valid knowledge, a research with inadequate design, execution and statistical analysis is not ethical either, since these methodological deficiencies will produce information that will not be useful and, therefore, the risks that the participants were exposed to will have been in vain. Beyond scientific validity, there are other aspects that outline if an investigation is ethical, such as the clinical and social value of a study, a fair selection of participants, favorable risk-benefit balance, an independent review, the informed consent and respect for participants and potential participants. Throughout the article here presented, the documents that profile the behavior of investigators to protect the participants, such as the Declaration of Helsinki, the national regulations that rule us and the differences between research without risk, with minimal risk and with greater than minimal risk are discussed. That like in daily life, behavior in research involving human participants must be self-regulated, ie, people with knowledge of the existence of the law discover that the man is outside the realm of nature where work is done under the necessity of natural causality, and falls within the scope of the will; only if the man is free to decide their actions may be a law regulating their action.

  16. Altruism in clinical research: coordinators' orientation to their professional roles.

    Science.gov (United States)

    Fisher, Jill A; Kalbaugh, Corey A

    2012-01-01

    Research coordinators have significant responsibilities in clinical trials that often require them to find unique ways to manage their jobs, thus reshaping their professional identities. The purpose of this study was to identify how research coordinators manage role and ethical conflicts within clinical research trials. A qualitative study combining observation and 63 semistructured interviews at 25 research organizations was used. Altruism is a recurring theme in how research coordinators define and view their work. Altruism is adopted by research coordinators to: (1) Teach patient-subjects the appropriate reasons to participate in clinical research, (2) minimize the conflict between research and care, and (3) contest the undervaluation of coordinating. Altruism is a strategy used to handle the various conflicts they experience in a difficult job, and it has become part of the professional identity of clinical research coordinators. Copyright © 2012 Elsevier Inc. All rights reserved.

  17. [An Investigation of the Role Responsibilities of Clinical Research Nurses in Conducting Clinical Trials].

    Science.gov (United States)

    Kao, Chi-Yin; Huang, Guey-Shiun; Dai, Yu-Tzu; Pai, Ya-Ying; Hu, Wen-Yu

    2015-06-01

    Clinical research nurses (CRNs) play an important role in improving the quality of clinical trials. In Taiwan, the increasing number of clinical trials has increased the number of practicing CRNs. Understanding the role responsibilities of CRNs is necessary to promote professionalism in this nursing category. This study investigates the role responsibilities of CRNs in conducting clinical trials / research. A questionnaire survey was conducted in a medical center in Taipei City, Taiwan. Eighty CRNs that were registered to facilitate and conduct clinical trials at this research site completed the survey. "Subject protection" was the CRN role responsibility most recognized by participants, followed by "research coordination and management", "subject clinical care", and "advanced professional nursing". Higher recognition scores were associated with higher importance scores and lower difficulty scores. Participants with trial training had significantly higher difficulty scores for "subject clinical care" and "research coordination and management" than their peers without this training (p research coordination and management" (p clinical practice.

  18. Safety Profile of Good Manufacturing Practice Manufactured Interferon γ-Primed Mesenchymal Stem/Stromal Cells for Clinical Trials.

    Science.gov (United States)

    Guess, Adam J; Daneault, Beth; Wang, Rongzhang; Bradbury, Hillary; La Perle, Krista M D; Fitch, James; Hedrick, Sheri L; Hamelberg, Elizabeth; Astbury, Caroline; White, Peter; Overolt, Kathleen; Rangarajan, Hemalatha; Abu-Arja, Rolla; Devine, Steven M; Otsuru, Satoru; Dominici, Massimo; O'Donnell, Lynn; Horwitz, Edwin M

    2017-10-01

    Mesenchymal stem/stromal cells (MSCs) are widely studied by both academia and industry for a broad array of clinical indications. The collective body of data provides compelling evidence of the clinical safety of MSC therapy. However, generally accepted proof of therapeutic efficacy has not yet been reported. In an effort to generate a more effective therapeutic cell product, investigators are focused on modifying MSC processing protocols to enhance the intrinsic biologic activity. Here, we report a Good Manufacturing Practice-compliant two-step MSC manufacturing protocol to generate MSCs or interferon γ (IFNγ) primed MSCs which allows freshly expanded cells to be infused in patients on a predetermined schedule. This protocol eliminates the need to infuse cryopreserved, just thawed cells which may reduce the immune modulatory activity. Moreover, using (IFNγ) as a prototypic cytokine, we demonstrate the feasibility of priming the cells with any biologic agent. We then characterized MSCs and IFNγ primed MSCs prepared with our protocol, by karyotype, in vitro potential for malignant transformation, biodistribution, effect on engraftment of transplanted hematopoietic cells, and in vivo toxicity in immune deficient mice including a complete post-mortem examination. We found no evidence of toxicity attributable to the MSC or IFNγ primed MSCs. Our data suggest that the clinical risk of infusing MSCs or IFNγ primed MSCs produced by our two-step protocol is not greater than MSCs currently in practice. While actual proof of safety requires phase I clinical trials, our data support the use of either cell product in new clinical studies. Stem Cells Translational Medicine 2017;6:1868-1879. © 2017 The Authors Stem Cells Translational Medicine published by Wiley Periodicals, Inc. on behalf of AlphaMed Press.

  19. Research Training in the Biomedical, Behavioral, and Clinical Research Sciences

    Science.gov (United States)

    National Academies Press, 2011

    2011-01-01

    Comprehensive research and a highly-trained workforce are essential for the improvement of health and health care both nationally and internationally. During the past 40 years the National Research Services Award (NRSA) Program has played a large role in training the workforce responsible for dramatic advances in the understanding of various…

  20. On Open Access to Research: The Green, the Gold, and the Public Good

    Science.gov (United States)

    Roach, Audra K.; Gainer, Jesse

    2013-01-01

    In this column the authors discuss barriers to worldwide open access to peer-reviewed journal articles online and how they might be addressed by literacy scholars. They highlight economic and ethical problems associated with the current subscription-based system for distributing articles (which sometimes works against the ideals of research and…

  1. More Research on Veteran Employment Would Show What’s Good for Business and for Veterans

    Science.gov (United States)

    2016-01-01

    approaches to addressing sexual harassment , sexual assault, hazing, and other problematic behaviors in the armed forces. ...indicate that certain cohorts of veterans are excelling in the workplace . For example, post-9/11 veterans’ median earnings are 11 percent higher than those...and programs, the October workshop focused on studies and research needs regarding leveraging skills that veterans bring to the workplace , effective

  2. Research-active clinical nurses: against all odds.

    Science.gov (United States)

    Siedlecki, Sandra L; Albert, Nancy M

    2017-03-01

    To develop a theoretical understanding of factors that impact decisions of clinical nurses to conduct a research study. Only a small percentage of all nurses are research-active and even fewer clinical nurses are research-active. Several researchers have explored barriers to research activity by clinical nurses, but few have examined why, in spite of all odds, some clinical nurses are research-active. As the purpose of this study was to develop a theoretical understanding of the research-active nurse, a grounded theory approach was used. The sample interviewed for this study consisted of registered nurses (n = 26) who worked in a hospital or ambulatory setting, had daily direct patient contact and had participated as principal investigator on at least one completed clinical nursing research study that was not in fulfilment of an educational requirement. The interviews were digitally recorded and analysed by two researchers using the constant comparative method. The findings from this study suggest that the conduct of research by clinical nurses was the direct result of a clinical trigger, characteristics and beliefs of the nurse about research and their role in generating knowledge, and the presence of support conditions, such as a research mentor. Clinical nurses can and do conduct research, in spite of constraints due to a lack of time, money and/or knowledge, if they have access to research mentors and are practising in a research-supportive environment. Nurses at the bedside are in a unique position to identify problems most in need of solutions. Findings from this study provide a foundation upon which to develop and test various programmes that seek to increase the number of clinical nurses who are research-active. © 2016 John Wiley & Sons Ltd.

  3. 59th Medical Wing Clinical Research Division Clinical Investigations Program Pathology Poster

    Science.gov (United States)

    2017-04-28

    59 MDW/SGVU SUBJECT: Professional Presentation Approval 1. Your paper, entitled 59th Medical Wing Clinical Research Division Clinical Investigations...Program Pathology Poster presented at/published to For hanging in a hallway of the 591h Medical Wing Clinical Research Division, Bldg 4430 in...Graduate Health Sciences Education student and your department has told you they cannot fund your publication, the 59th Clinical Research Division may

  4. Frequently Asked Questions about Clinical Research

    Science.gov (United States)

    ... Care Genomic Medicine Working Group New Horizons and Research Patient Management Policy and Ethics Issues Quick Links for Patient Care Education All About the Human Genome Project Fact Sheets Genetic Education Resources for ...

  5. Human embryonic stem cells and good manufacturing practice: Report of a 1- day workshop held at Stem Cell Biology Research Center, Yazd, 27th April 2017

    Directory of Open Access Journals (Sweden)

    Fatemeh Akyash

    2017-09-01

    Full Text Available This report explains briefly the minutes of a 1-day workshop entitled; “human embryonic stem cells (hESCs and good manufacturing practice (GMP” held by Stem Cell Biology Research Center based in Yazd Reproductive Sciences Institute at Shahid Sadoughi University of Medical Sciences, Yazd, Iran on 27th April 2017. In this workshop, in addition to the practical sessions, Prof. Harry D. Moore from Centre for Stem Cell Biology, University of Sheffield, UK presented the challenges and the importance of the biotechnology of clinical-grade human embryonic stem cells from first derivation to robust defined culture for therapeutic applications.

  6. Human embryonic stem cells and good manufacturing practice: Report of a 1- day workshop held at Stem Cell Biology Research Center, Yazd, 27th April 2017.

    Science.gov (United States)

    Akyash, Fatemeh; Sadeghian-Nodoushan, Fatemeh; Tahajjodi, Somayyeh Sadat; Nikukar, Habib; Farashahi Yazd, Ehsan; Azimzadeh, Mostafa; D Moore, Harry; Aflatoonian, Behrouz

    2017-05-01

    This report explains briefly the minutes of a 1-day workshop entitled; "human embryonic stem cells (hESCs) and good manufacturing practice (GMP)" held by Stem Cell Biology Research Center based in Yazd Reproductive Sciences Institute at Shahid Sadoughi University of Medical Sciences, Yazd, Iran on 27 th April 2017. In this workshop, in addition to the practical sessions, Prof. Harry D. Moore from Centre for Stem Cell Biology, University of Sheffield, UK presented the challenges and the importance of the biotechnology of clinical-grade human embryonic stem cells from first derivation to robust defined culture for therapeutic applications.

  7. [Clinical research XXIII. From clinical judgment to meta-analyses].

    Science.gov (United States)

    Rivas-Ruiz, Rodolfo; Castelán-Martínez, Osvaldo D; Pérez-Rodríguez, Marcela; Palacios-Cruz, Lino; Noyola-Castillo, Maura E; Talavera, Juan O

    2014-01-01

    Systematic reviews (SR) are studies made in order to ask clinical questions based on original articles. Meta-analysis (MTA) is the mathematical analysis of SR. These analyses are divided in two groups, those which evaluate the measured results of quantitative variables (for example, the body mass index -BMI-) and those which evaluate qualitative variables (for example, if a patient is alive or dead, or if he is healing or not). Quantitative variables generally use the mean difference analysis and qualitative variables can be performed using several calculations: odds ratio (OR), relative risk (RR), absolute risk reduction (ARR) and hazard ratio (HR). These analyses are represented through forest plots which allow the evaluation of each individual study, as well as the heterogeneity between studies and the overall effect of the intervention. These analyses are mainly based on Student's t test and chi-squared. To take appropriate decisions based on the MTA, it is important to understand the characteristics of statistical methods in order to avoid misinterpretations.

  8. Experiments in interdisciplinarity: Responsible research and innovation and the public good

    Science.gov (United States)

    Åm, Heidrun

    2018-01-01

    In Europe, responsible research and innovation (RRI) has emerged as a science policy measure that demands the early integration of a broad range of social actors and perspectives into research and development (R&D). More collaboration of the social sciences and humanities (SSH) with science and engineering appears within this policy framework as a crucial element that will enable better technological development. However, RRI is new to both natural scientists and SSH scholars, and interdisciplinary collaborations are challenging for many reasons. In this paper, we discuss these challenges while suggesting that what RRI can be in a particular project is not a given but remains an empirical question. Natural scientists and SSH scholars need to coresearch RRI in an experimental mode. PMID:29579043

  9. Experiments in interdisciplinarity: Responsible research and innovation and the public good.

    Science.gov (United States)

    Delgado, Ana; Åm, Heidrun

    2018-03-01

    In Europe, responsible research and innovation (RRI) has emerged as a science policy measure that demands the early integration of a broad range of social actors and perspectives into research and development (R&D). More collaboration of the social sciences and humanities (SSH) with science and engineering appears within this policy framework as a crucial element that will enable better technological development. However, RRI is new to both natural scientists and SSH scholars, and interdisciplinary collaborations are challenging for many reasons. In this paper, we discuss these challenges while suggesting that what RRI can be in a particular project is not a given but remains an empirical question. Natural scientists and SSH scholars need to coresearch RRI in an experimental mode.

  10. How to emerge from the conservatism in clinical research methodology?

    Science.gov (United States)

    Kotecki, Nuria; Penel, Nicolas; Awada, Ahmad

    2017-09-01

    Despite recent changes in clinical research methodology, many challenges remain in drug development methodology. Advances in molecular biology and cancer treatments have changed the clinical research landscape. Thus, we moved from empirical clinical oncology to molecular and immunological therapeutic approaches. Along with this move, adapted dose-limiting toxicities definitions, endpoints, and dose escalation methods have been proposed. Moreover, the classical frontier between phase I, phase II, and phase III has become unclear in particular for immunological approaches. So, investigators are facing major challenges in drug development methodology. We propose to individualize clinical research using innovative approaches to significantly improve patient outcomes and targeting what is considered unmet need. Integrating high level of translational research and performing well designed biomarker studies with great potential for clinical practice are of utmost importance. This could be performed within new models of clinical research networks and by building a strong collaboration between academic, cooperative groups, on-site investigators, and pharma.

  11. 77 FR 64598 - Joint Biomedical Laboratory Research and Development and Clinical Science Research and...

    Science.gov (United States)

    2012-10-22

    ... DEPARTMENT OF VETERANS AFFAIRS Joint Biomedical Laboratory Research and Development and Clinical...) that the panels of the Joint Biomedical Laboratory Research and Development and Clinical Science... areas of biomedical, behavioral and clinical science research. The panel meetings will be open to the...

  12. How do we know if a clinical practice guideline is good? A response to Djulbegovic and colleagues' use of fast-and-frugal decision trees to improve clinical care strategies.

    Science.gov (United States)

    Mercuri, Mathew

    2018-04-17

    Clinical practice guidelines (CPGs) and clinical pathways have become important tools for improving the uptake of evidence-based care. Where CPGs are good, adherence to the recommendations within is thought to result in improved patient outcomes. However, the usefulness of such tools for improving patient important outcomes depends both on adherence to the guideline and whether or not the CPG in question is good. This begs the question of what it is that makes a CPG good? In this issue of the Journal, Djulbegovic and colleagues offer a theory to help guide the development of CPGs. The "fast-and-frugal tree" (FFT) heuristic theory is purported to provide the theoretical structure needed to quantitatively assess clinical guidelines in practice, something that the lack of theory to guide CPG development has precluded. In this paper, I examine the role of FFTs in providing an adequate theoretical framework for developing CPGs. In my view, positioning guideline development within the FFT framework may help with problems related to adherence. However, I believe that FTTs fall short in providing panel members with the theoretical basis needed to justify which factors should be considered when developing a CPG, how information on those factors derived from research studies should be interpreted, and how those factors should be integrated into the recommendation. © 2018 John Wiley & Sons, Ltd.

  13. 'A good fit?' Bringing the sociology of footwear to the clinical encounter in podiatry services: a narrative review.

    Science.gov (United States)

    Nicholls, Emily; Robinson, Victoria; Farndon, Lisa; Vernon, Wesley

    2018-01-01

    This narrative review explores the ways in which drawing on theories and methods used in sociological work on footwear and identity can contribute to healthcare research with podiatrists and their patients, highlighting recent research in this field, implications for practice and potential areas for future development.Traditionally, research within Podiatry Services has tended to adopt a quantitative, positivist focus, developing separately from a growing body of sociological work exploring the importance of shoes in constructing identity and self-image. Bringing qualitative research drawing on sociological theory and methods to the clinical encounter has real potential to increase our understanding of patient values, motivations and - crucially - any barriers to adopting 'healthier' footwear that they may encounter. Such work can help practitioners to understand why patients may resist making changes to their footwear practices, and help us to devise new ways for practitioners to explore and ultimately break down individual barriers to change (including their own preconceptions as practitioners). This, in turn, may lead to long-term, sustainable changes to footwear practices and improvements in foot health for those with complex health conditions and the wider population. A recognition of the complex links between shoes and identity is opening up space for discussion of patient resistance to footwear changes, and paving the way for future research in this field beyond the temporary 'moment' of the clinical encounter.

  14. [Analysis of good practices for inhabitant participation in the clinical management units of the Andalusian Health Service (Spain)].

    Science.gov (United States)

    Gómez Martínez, M Eugenia; Pastor Moreno, Guadalupe; Pérez Corral, Olivia; Iriarte de Los Santos, M Teresa; Mena Jiménez, Ángel Luis; Escudero Espinosa, M Cecilia; García Romera, Inmaculada; Blanco García, Martín Germán; Martín Barato, Amelia

    To discover good practices for inhabitant participation in the clinical management units (CMUs) of the Andalusian Health Service (AHS) (Spain) and to explore the reasons perceived by CMU and AHS professionals that may influence the presence and distribution of those good practices among the CMU. Study with mixed methodology carried out in Andalusia (Spain) in two phases (2013-2015). Firstly, an online survey was delivered to the Directors of the CMUs which had set up an inhabitant participation commission. In a second phase, a qualitative study was carried out through semi-structured interviews with professionals from the Andalusian Health Service with previous experience in inhabitant participation. A descriptive analysis of the quantitative information and a semantic content analysis of the qualitative information were carried out. 530 CMUs took part in the survey. The inhabitant participation practices more often implemented in the CMUs are those related to the informing and consultation levels. Twelve professionals were interviewed in the second phase. Other practices with higher inhabitant involvement and delegation are secondary. The barriers which were identified by professionals are related to the beliefs and attitudes of the inhabitants, the professionals, the health system and the environment. The main practices for inhabitant participation in the CMUs are related to the most basic levels of participation. The method and dynamics which facilitate inhabitant empowerment within the health system are not clearly recognised. Copyright © 2016 SESPAS. Publicado por Elsevier España, S.L.U. All rights reserved.

  15. "A good personal scientific relationship": Philip Morris scientists and the Chulabhorn Research Institute, Bangkok.

    Science.gov (United States)

    Mackenzie, Ross; Collin, Jeff

    2008-12-23

    This paper examines the efforts of consultants affiliated with Philip Morris (PM), the world's leading transnational tobacco corporation, to influence scientific research and training in Thailand via the Chulabhorn Research Institute (CRI). A leading Southeast Asian institute for environmental health science, the CRI is headed by Professor Dr. Her Royal Highness Princess Chulabhorn, the daughter of the King of Thailand, and it has assumed international significance via its designation as a World Health Organization (WHO) Collaborating Centre in December 2005. This paper analyses previously confidential tobacco industry documents that were made publicly available following litigation in the United States. PM documents reveal that ostensibly independent overseas scientists, now identified as industry consultants, were able to gain access to the Thai scientific community. Most significantly, PM scientist Roger Walk has established close connections with the CRI. Documents indicate that Walk was able to use such links to influence the study and teaching of environmental toxicology in the institute and to develop relations with key officials and local scientists so as to advance the interests of PM within Thailand and across Asia. While sensitivities surrounding royal patronage of the CRI make public criticism extremely difficult, indications of ongoing involvement by tobacco industry consultants suggest the need for detailed scrutiny of such relationships. The establishment of close links with the CRI advances industry strategies to influence scientific research and debate around tobacco and health, particularly regarding secondhand smoke, to link with academic institutions, and to build relationships with national elites. Such strategies assume particular significance in the national and regional contexts presented here amid the globalisation of the tobacco pandemic. From an international perspective, particular concern is raised by the CRI's recently awarded status

  16. The master builders : LAIRAH research on good practice in the construction of digital humanities projects.

    OpenAIRE

    Warwick, C.; Terras, M.; Huntington, P.; Pappa, N.; Galina, I.

    2007-01-01

    This paper describes the results of research carried out during the LAIRAH (Log analysis of Internet Resources in the Arts and Humanities) project (http://www.ucl.ac.uk/slais/circah/lairah/) which is based at UCL’s School of Library Archive and Information Studies. It was a fifteen month study (reporting in October 2006) to discover what influences the long-term sustainability and use of digital resources in the humanities through the analysis and evaluation of real-time use. At Digital Human...

  17. Good clinical practice guide for opioids in pain management: the three Ts - titration (trial, tweaking (tailoring, transition (tapering

    Directory of Open Access Journals (Sweden)

    Flaminia Coluzzi

    2016-06-01

    Full Text Available ABSTRACT BACKGROUND AND OBJECTIVES: Achieving good clinical practice in the use of opioids as part of a comprehensive pain management regimen can face significant challenges. Despite guidelines from governmental and pain society/organization sources, there are still significant hurdles. A review of some basic tenets of opioid analgesia based on current published knowledge and experiences about this important healthcare imperative is warranted. CONTENT: Consistent with guidelines, the literature supports using the lowest total opioid dose that provides adequate pain control with the fewest adverse effects. Titration (or trial during opioid initiation is a way of starting low and going slow (and assessing the appropriateness of a specific opioid and formulation. Recognizing that multiple factors contribute to an individual's personal experience of pain, the physical, psychological, social, cultural, spiritual, pharmacogenomic, and behavioral factors of the individual patient should be taken into account (tweaking, or tailoring. Finally, for those patients for whom transition (tapering from opioid is desired, doing so too rapidly can have negative consequences and minimization of problems during this step can be achieved by proper tapering. CONCLUSION: We conclude that a simultaneously aggressive, yet conservative, approach is advocated in the literature in which opioid therapy is divided into three key steps (the 3 T's: titration (or trial, tweaking (or tailoring, and transition (or tapering. Establishment of the 3 T's along with the application of other appropriate good medical practice and clinical experience/judgment, including non-pharmacologic approaches, can assist healthcare providers in the effort to achieve optimal management of pain.

  18. Ophthalmology and vision science research: Part 3: avoiding writer's block--understanding the ABCs of a good research paper.

    Science.gov (United States)

    McGhee, Charles N J; Gilhotra, Amardeep K

    2005-12-01

    Completion of a scientific manuscript for submission to a peer-reviewed journal is a daunting task for clinicians and scientists early in their careers. In an ongoing series, this third article is the first of 2 related articles that deal with the basics of producing a high-quality research manuscript. Although ophthalmology and vision science are the principal focus of this series, the general concepts essential to producing a quality manuscript are applicable to diverse fields of research. This article highlights the exponential growth in the scientific literature over the past 40 years, considers why it is important to publish completed research, and discusses the necessity of identifying the key messages of the research, and their context, in relation to the published literature. The ethics of publishing biomedical research and scientific misconduct, such as duplicate publication or plagiarism, are outlined. To avoid later conflict, there is a critical need for coworkers to carefully address authorship order and inclusion early in the manuscript process. Internationally agreed guidelines are identified to guide this process. The importance of choosing the correct journal for a specific article and the nature of basic citation indices are discussed. The article concludes by elaborating and contrasting different scientific writing styles and emphasizing the considerable importance of developing a representative title and applying clarity and appropriate structure to the abstract.

  19. Transforming Research Management Systems at Mayo Clinic

    Science.gov (United States)

    Smith, Steven C.; Gronseth, Darren L.

    2011-01-01

    In order for research programs at academic medical centers and universities to survive and thrive in the increasingly challenging economic, political and regulatory environment, successful transformation is extremely important. Transformation and quality management techniques are increasingly well established in medical practice organizations. In…

  20. Enrolling Minority and Underserved Populations in Cancer Clinical Research.

    Science.gov (United States)

    Wallington, Sherrie F; Dash, Chiranjeev; Sheppard, Vanessa B; Goode, Tawara D; Oppong, Bridget A; Dodson, Everett E; Hamilton, Rhonda N; Adams-Campbell, Lucile L

    2016-01-01

    Research suggests that community involvement is integral to solving public health problems, including involvement in clinical trials-a gold standard. Significant racial/ethnic disparities exist in the accrual of participants for clinical trials. Location and cultural aspects of clinical trials influence recruitment and accrual to clinical trials. It is increasingly necessary to be aware of defining characteristics, such as location and culture of the populations from which research participants are enrolled. Little research has examined the effect of location and cultural competency in adapting clinical trial research for minority and underserved communities on accrual for clinical trials. Utilizing embedded community academic sites, the authors applied cultural competency frameworks to adapt clinical trial research in order to increase minority participation in nontherapeutic cancer clinical trials. This strategy resulted in successful accrual of participants to new clinical research trials, specifically targeting participation from minority and underserved communities in metropolitan Washington, DC. From 2012 to 2014, a total of 559 participants enrolled across six nontherapeutic clinical trials, representing a 62% increase in the enrollment of blacks in clinical research. Embedding cancer prevention programs and research in the community was shown to be yet another important strategy in the arsenal of approaches that can potentially enhance clinical research enrollment and capacity. The analyses showed that the capacity to acquire cultural knowledge about patients-their physical locales, cultural values, and environments in which they live-is essential to recruiting culturally and ethnically diverse population samples. Copyright © 2016 American Journal of Preventive Medicine. Published by Elsevier Inc. All rights reserved.

  1. "A good personal scientific relationship": Philip Morris scientists and the Chulabhorn Research Institute, Bangkok.

    Directory of Open Access Journals (Sweden)

    Ross Mackenzie

    2008-12-01

    Full Text Available This paper examines the efforts of consultants affiliated with Philip Morris (PM, the world's leading transnational tobacco corporation, to influence scientific research and training in Thailand via the Chulabhorn Research Institute (CRI. A leading Southeast Asian institute for environmental health science, the CRI is headed by Professor Dr. Her Royal Highness Princess Chulabhorn, the daughter of the King of Thailand, and it has assumed international significance via its designation as a World Health Organization (WHO Collaborating Centre in December 2005.This paper analyses previously confidential tobacco industry documents that were made publicly available following litigation in the United States. PM documents reveal that ostensibly independent overseas scientists, now identified as industry consultants, were able to gain access to the Thai scientific community. Most significantly, PM scientist Roger Walk has established close connections with the CRI. Documents indicate that Walk was able to use such links to influence the study and teaching of environmental toxicology in the institute and to develop relations with key officials and local scientists so as to advance the interests of PM within Thailand and across Asia. While sensitivities surrounding royal patronage of the CRI make public criticism extremely difficult, indications of ongoing involvement by tobacco industry consultants suggest the need for detailed scrutiny of such relationships.The establishment of close links with the CRI advances industry strategies to influence scientific research and debate around tobacco and health, particularly regarding secondhand smoke, to link with academic institutions, and to build relationships with national elites. Such strategies assume particular significance in the national and regional contexts presented here amid the globalisation of the tobacco pandemic. From an international perspective, particular concern is raised by the CRI's recently

  2. A good operator-process relation research in Creys-Malville project

    International Nuclear Information System (INIS)

    Decuyper, J.; Reynaud, S.; Hoepner, A.; Rolland

    1980-01-01

    This paper deals with the approaches undertaken by NERSA in order to get an optimal man-machine interface design, both in normal and in abnormal operation conditions at the Super-Phenix Reactor. The main features followed are: 1) adopting of a control system allowing the easiest process control and operating (this aspect has been presented recently in a paper at a previous meeting, see ref. 1, and will therefore not be exposed); 2) design of the control room according to the operational simulation data and the control and instrumentation devices which are to be installed; 3) research of optimal operating procedures, mainly during load variations and during abnormal operating conditions; 4) operator's training. (orig./HP)

  3. AIDS--Challenges to Basic and Clinical Biomedical Research.

    Science.gov (United States)

    Fauci, Anthony S.

    1989-01-01

    Clinical trials and access to therapeutic drugs pose dilemmas for researchers, physicians, and AIDS patients. The National Institute of Allergy and Infectious Diseases, recognizing the need for greater access to drugs by a broader spectrum of the infected population, is establishing the Community Programs for Clinical Research on AIDS. (Author/MLW)

  4. Legitimating Clinical Research in the Study of Organizational Culture.

    Science.gov (United States)

    Schein, Edgar H.

    1993-01-01

    Argues that traditional research model used in industrial-organizational psychology is not useful in understanding deeper dynamics of organizations, especially those phenomena labeled as "cultural." Contends that use of data obtained during clinical and consulting work should be legitimated as valid research data. Spells out clinical model and…

  5. Reporting of clinical trials: a review of research funders' guidelines

    Directory of Open Access Journals (Sweden)

    Williamson Paula R

    2008-11-01

    Full Text Available Abstract Background Randomised controlled trials (RCTs represent the gold standard methodological design to evaluate the effectiveness of an intervention in humans but they are subject to bias, including study publication bias and outcome reporting bias. National and international organisations and charities give recommendations for good research practice in relation to RCTs but to date no review of these guidelines has been undertaken with respect to reporting bias. Methods National and international organisations and UK based charities listed on the Association for Medical Research Charities website were contacted in 2007; they were considered eligible for this review if they funded RCTs. Guidelines were obtained and assessed in relation to what was written about trial registration, protocol adherence and trial publication. It was also noted whether any monitoring against these guidelines was undertaken. This information was necessary to discover how much guidance researchers are given on the publication of results, in order to prevent study publication bias and outcome reporting bias. Results Seventeen organisations and 56 charities were eligible of 140 surveyed for this review, although there was no response from 12. Trial registration, protocol adherence, trial publication and monitoring against the guidelines were often explicitly discussed or implicitly referred too. However, only eleven of these organisations or charities mentioned the publication of negative as well as positive outcomes and just three of the organisations specifically stated that the statistical analysis plan should be strictly adhered to and all changes should be reported. Conclusion Our review indicates that there is a need to provide more detailed guidance for those conducting and reporting clinical trials to help prevent the selective reporting of results. Statements found in the guidelines generally refer to publication bias rather than outcome reporting bias

  6. [From brain imaging to good teaching? implicating from neuroscience for research on learning and instruction].

    Science.gov (United States)

    Stubenrauch, Christa; Krinzinger, Helga; Konrad, Kerstin

    2014-07-01

    Psychiatric disorders in childhood and adolescence, in particular attention deficit disorder or specific learning disorders like developmental dyslexia and developmental dyscalculia, affect academic performance and learning at school. Recent advances in neuroscientific research have incited an intensive debate both in the general public and in the field of educational and instructional science as well as to whether and to what extent these new findings in the field of neuroscience might be of importance for school-related learning and instruction. In this review, we first summarize neuroscientific findings related to the development of attention, working memory and executive functions in typically developing children and then evaluate their relevance for school-related learning. We present an overview of neuroimaging studies of specific learning disabilities such as developmental dyslexia and developmental dyscalculia, and critically discuss their practical implications for educational and teaching practice, teacher training, early diagnosis as well as prevention and disorder-specific therapy. We conclude that the new interdisciplinary field of neuroeducation cannot be expected to provide direct innovative educational applications (e.g., teaching methods). Rather, the future potential of neuroscience lies in creating a deeper understanding of the underlying cognitive mechanisms and pathomechanisms of learning processes and learning disorders.

  7. Gender mainstreaming european transport research and policies. Building the knowledge base and mapping good practices

    Energy Technology Data Exchange (ETDEWEB)

    Roemer Christensen, H; Poulsen, H; Hjorth Oldrup, H; Malthesen, T; Hvidt Breengaard, M; Holmen, M

    2007-07-01

    This report documents that there are clear and persistent gender differences in travel patterns. Men consistently travel further than women, men are more likely to travel by car and women by public transport, and women's trips tend to be more local. Explanations to these differences are linked to unequal gendered relations in the household and labour market and urban structures as well as gender socialisation. This means that men and women make different uses of a shared system of transport. Transport is an overwhelmingly male-dominated sector. At the EU level, political committees in the transport sector as well as transport research and advisory boards have a marked gender imbalance with less than 15% female membership in most boards and none with equal representation. This also goes for transport-related committees at national levels. Yet with one notable exception: Sweden has a 50-50 balance in the National Transport Committee. Current gender mainstreaming initiatives in the transport sector relate to a wide range of issues: They relate to planning and policy, safety issues, gendering of technology as well as employment. The report substantiates that the implementation of equality programmes, and not their formulation makes up the biggest challenge. One programme does not solve all problems, but opens up new avenues for initiatives and intervention. Gender is a central stratifying factor in transport use at all levels. In order to provide a more complete picture of gender differences, and in order to qualify EU goals of combating multi-level inequalities, there is a need to link gender with the broader axes of inequalities, namely ethnicity, sexuality, age and handicap in future studies of transport and mobility. (au)

  8. Gender mainstreaming european transport research and policies. Building the knowledge base and mapping good practices

    Energy Technology Data Exchange (ETDEWEB)

    Roemer Christensen, H.; Poulsen, H.; Hjorth Oldrup, H.; Malthesen, T.; Hvidt Breengaard, M.; Holmen, M.

    2007-07-01

    This report documents that there are clear and persistent gender differences in travel patterns. Men consistently travel further than women, men are more likely to travel by car and women by public transport, and women's trips tend to be more local. Explanations to these differences are linked to unequal gendered relations in the household and labour market and urban structures as well as gender socialisation. This means that men and women make different uses of a shared system of transport. Transport is an overwhelmingly male-dominated sector. At the EU level, political committees in the transport sector as well as transport research and advisory boards have a marked gender imbalance with less than 15% female membership in most boards and none with equal representation. This also goes for transport-related committees at national levels. Yet with one notable exception: Sweden has a 50-50 balance in the National Transport Committee. Current gender mainstreaming initiatives in the transport sector relate to a wide range of issues: They relate to planning and policy, safety issues, gendering of technology as well as employment. The report substantiates that the implementation of equality programmes, and not their formulation makes up the biggest challenge. One programme does not solve all problems, but opens up new avenues for initiatives and intervention. Gender is a central stratifying factor in transport use at all levels. In order to provide a more complete picture of gender differences, and in order to qualify EU goals of combating multi-level inequalities, there is a need to link gender with the broader axes of inequalities, namely ethnicity, sexuality, age and handicap in future studies of transport and mobility. (au)

  9. Progress in clinical research of asteroid hyalosis

    Directory of Open Access Journals (Sweden)

    Xiao-Xue Liu

    2017-08-01

    Full Text Available Asteroid Hyalosis(AHis a common clinical disease, which has been considered a benign disorder as it rarely impairs visual acuity. It was often discovered when the patient was treated for other eye diseases. The mechanism was unclear. Its characteristic B-ultrasound property makes the B-ultrasound a very helpful diagnostic technique. In the case of the patients with other fundus diseases associated with AH, optical coherence tomography(OCTand fluorescein angiography(FAmay be used to reduce the interference from asteroid bodies, therefore improve the fundus visibility. Recent studies have shown that AH can incorporate with many other eye diseases. For example, in patients with cataracts, asteroid hyalosis can cause surface calcification of silicone plate intraocular lenses, which in most cases may lead to the need for explantation of the calcified intraocular lenses. The efficacy of pars plana vitrectomy(PPV, the removal of some, or all, of the eye's vitreous humor for AH remains controversial. In this paper, we provide a review of the recent literature on AH disease: the etiology, diagnosis and treatment. We hope to thus improve the awareness and outcomes of AH disease.

  10. The Microcomputer in the Clinical Nursing Research Unit

    Science.gov (United States)

    Schwirian, Patricia M.; Byers, Sandra R.

    1982-01-01

    This paper discusses the microcomputer in clinical nursing research. There are six general areas in which computers have been useful to nurses: nursing notes and charting; patient care plans; automated monitoring of high-tech nursing units; HIS and MIS systems; personnel distribution systems; and education. Three alternative models for the conduct of clinical nursing research in a hospital are described. The first is a centralized model relying on the bureaucratic structure of the hospital. Second is a decentralized network of professional nurses and research support personnel woven together by a Clinical Nurse Researcher, and third is a dedicated clinical nursing research unit. Microcomputers have five characteristics which make them vital tools for nurse researchers: user-friendliness; environment friendliness; low cost; ease of interface with other information systems; and range and quality of software.

  11. Data management by using R: big data clinical research series.

    Science.gov (United States)

    Zhang, Zhongheng

    2015-11-01

    Electronic medical record (EMR) system has been widely used in clinical practice. Instead of traditional record system by hand writing and recording, the EMR makes big data clinical research feasible. The most important feature of big data research is its real-world setting. Furthermore, big data research can provide all aspects of information related to healthcare. However, big data research requires some skills on data management, which however, is always lacking in the curriculum of medical education. This greatly hinders doctors from testing their clinical hypothesis by using EMR. To make ends meet, a series of articles introducing data management techniques are put forward to guide clinicians to big data clinical research. The present educational article firstly introduces some basic knowledge on R language, followed by some data management skills on creating new variables, recoding variables and renaming variables. These are very basic skills and may be used in every project of big data research.

  12. Science, Technology and Innovation as Social Goods for Development: Rethinking Research Capacity Building from Sen's Capabilities Approach.

    Science.gov (United States)

    Mormina, Maru

    2018-03-01

    Science and technology are key to economic and social development, yet the capacity for scientific innovation remains globally unequally distributed. Although a priority for development cooperation, building or developing research capacity is often reduced in practice to promoting knowledge transfers, for example through North-South partnerships. Research capacity building/development tends to focus on developing scientists' technical competencies through training, without parallel investments to develop and sustain the socioeconomic and political structures that facilitate knowledge creation. This, the paper argues, significantly contributes to the scientific divide between developed and developing countries more than any skills shortage. Using Charles Taylor's concept of irreducibly social goods, the paper extends Sen's Capabilities Approach beyond its traditional focus on individual entitlements to present a view of scientific knowledge as a social good and the capability to produce it as a social capability. Expanding this capability requires going beyond current fragmented approaches to research capacity building to holistically strengthen the different social, political and economic structures that make up a nation's innovation system. This has implications for the interpretation of human rights instruments beyond their current focus on access to knowledge and for focusing science policy and global research partnerships to design approaches to capacity building/development beyond individual training/skills building.

  13. Integration of clinical research documentation in electronic health records.

    Science.gov (United States)

    Broach, Debra

    2015-04-01

    Clinical trials of investigational drugs and devices are often conducted within healthcare facilities concurrently with clinical care. With implementation of electronic health records, new communication methods are required to notify nonresearch clinicians of research participation. This article reviews clinical research source documentation, the electronic health record and the medical record, areas in which the research record and electronic health record overlap, and implications for the research nurse coordinator in documentation of the care of the patient/subject. Incorporation of clinical research documentation in the electronic health record will lead to a more complete patient/subject medical record in compliance with both research and medical records regulations. A literature search provided little information about the inclusion of clinical research documentation within the electronic health record. Although regulations and guidelines define both source documentation and the medical record, integration of research documentation in the electronic health record is not clearly defined. At minimum, the signed informed consent(s), investigational drug or device usage, and research team contact information should be documented within the electronic health record. Institutional policies should define a standardized process for this integration in the absence federal guidance. Nurses coordinating clinical trials are in an ideal position to define this integration.

  14. Strategies to successfully recruit and engage clinical nurses as participants in qualitative clinical research.

    Science.gov (United States)

    Coyne, Elisabeth; Grafton, Eileen; Reid, Alayne

    2016-12-01

    Research conducted in the clinical area promotes the delivery of evidence-based patient care. Involving nurses as participants in research is considered essential to link patient care with evidence-based interventions. However recruitment is influenced by nurses' competing demands and understanding engagement strategies may assist future research. This reflective analysis aimed to understand influencing factors and strategies that support successful recruitment nurses in clinical research. A reflective analysis of research notes and focus group data from research with oncology nurses was completed. This research identified that gaining support from key staff, understanding work constraints and developing a rapport with nurses is important. Establishing clear relevance and benefits of the research and being flexible with research requirements enabled nurses to participate in the research. Clear information and a willingness to accommodate the demands and dynamic nature of the environment, ensures ongoing support and engagement of nurses in the clinical setting as participants in research.

  15. A metadata schema for data objects in clinical research.

    Science.gov (United States)

    Canham, Steve; Ohmann, Christian

    2016-11-24

    A large number of stakeholders have accepted the need for greater transparency in clinical research and, in the context of various initiatives and systems, have developed a diverse and expanding number of repositories for storing the data and documents created by clinical studies (collectively known as data objects). To make the best use of such resources, we assert that it is also necessary for stakeholders to agree and deploy a simple, consistent metadata scheme. The relevant data objects and their likely storage are described, and the requirements for metadata to support data sharing in clinical research are identified. Issues concerning persistent identifiers, for both studies and data objects, are explored. A scheme is proposed that is based on the DataCite standard, with extensions to cover the needs of clinical researchers, specifically to provide (a) study identification data, including links to clinical trial registries; (b) data object characteristics and identifiers; and (c) data covering location, ownership and access to the data object. The components of the metadata scheme are described. The metadata schema is proposed as a natural extension of a widely agreed standard to fill a gap not tackled by other standards related to clinical research (e.g., Clinical Data Interchange Standards Consortium, Biomedical Research Integrated Domain Group). The proposal could be integrated with, but is not dependent on, other moves to better structure data in clinical research.

  16. Knowledge Creation in Clinical Product Development Management Research

    DEFF Research Database (Denmark)

    Karlsson, Christer; Sköld, Martin

    2012-01-01

    This paper explores the clinical approach to management research and positions it in relation to other similar approaches. It achieves this by pointing out the most important historical milestones in the development of such approaches. The literature on the approach is mapped, including that on t......This paper explores the clinical approach to management research and positions it in relation to other similar approaches. It achieves this by pointing out the most important historical milestones in the development of such approaches. The literature on the approach is mapped, including...... of the approaches, the paper discusses the research issues to which clinical research is relevant and how the research framework should be designed, then practical issues relating to how to approach the study objects, the design of the research instruments, and the conducting of the field research. Finally...

  17. Clinical Research Nursing: A Critical Resource in the National Research Enterprise

    Science.gov (United States)

    Hastings, Clare E.; Fisher, Cheryl A.; McCabe, Margaret A.

    2012-01-01

    Translational clinical research has emerged as an important priority for the national research enterprise, with a clearly stated mandate to deliver prevention strategies, treatments and cures based on scientific innovations faster to the public. Within this national effort, a lack of consensus persists concerning the need for clinical nurses with expertise and specialized training in study implementation and the delivery of care to research participants. This paper reviews efforts to define and document the role of practicing nurses in implementing studies and coordinating clinical research in a variety of clinical settings and differentiates this clinical role from the role of nurses as scientists and principal investigators. We propose an agenda for building evidence that having nurses provide and coordinate study treatments and procedures can potentially improve research efficiency, participant safety, and the quality of research data. We also provide recommendations for the development of the emerging specialty of clinical research nursing. PMID:22172370

  18. It is time to revise the international Good Clinical Practices guidelines: recommendations from non-commercial North-South collaborative trials.

    Science.gov (United States)

    Ravinetto, Raffaella; Tinto, Halidou; Diro, Ermias; Okebe, Joseph; Mahendradhata, Yodi; Rijal, Suman; Gotuzzo, Eduardo; Lutumba, Pascal; Nahum, Alain; De Nys, Katelijne; Casteels, Minne; Boelaert, Marleen

    2016-01-01

    The Good Clinical Practices (GCP) codes of the WHO and the International Conference of Harmonization set international standards for clinical research. But critics argue that they were written without consideration for the challenges faced in low and middle income countries (LMICs). Based on our field experience in LMICs, we developed a non-exhaustive set of recommendations for the improvement of GCP. These cover 3 domains: ethical, legal and operational, and 8 specific issues: the double ethical review of 'externally sponsored' trials; the informed consent procedure in minors and in illiterate people; post-trial access to newly-developed products for the trial communities; the role of communities as key research actors; the definition of sponsor; and the guidance for contractual agreements, laboratory quality management systems, and quality assurance of investigational medicinal products. Issues not covered in our analysis include among others biobanking, standard of care, and study designs. The international GCP codes de facto guide national legislators and funding agencies, so the current shortcomings may weaken the regulatory oversight of international research. In addition, activities neglected by GCP are less likely to be implemented or funded. If GCP are meant to serve the interests of global society, a comprehensive revision is needed. The revised guidelines should be strongly rooted in ethics, sensitive to different sociocultural perspectives, and allow consideration for trial-specific and context-specific challenges. This can be only achieved if all stakeholders, including researchers, sponsors, regulators, ethical reviewers and patients' representatives from LMICs, as well as non-commercial researchers and sponsors from affluent countries, are transparently involved in the revision process. We hope that our limited analysis would foster advocacy for a broad and inclusive revision of the international GCP codes, to make them at the same time 'global

  19. Participation in HIV research: the importance of clinic contact factors.

    Science.gov (United States)

    Worthington, Catherine A; Gill, M John

    2008-08-01

    Recruiting minority populations living with HIV to many types of clinic-based HIV research is a concern. This study examined an expanded range of predictors of HIV research participation (clinic contact, clinical, and personal characteristics) to investigate observed ethnocultural differences in HIV research participation. Research participation was defined as participation in any of diagnostic, pathogenesis, drug trial or survey research. Logistic regression modeling was used to predict research participation of 657 eligible patients (93% of the patient population) who began care between January 1997 and the end of September 2003 at a regional outpatient HIV care program in Calgary, Canada. Approximately one third (32%) were non-white, including 18% Aboriginal, 9% black, 4% Asian, and 1% Hispanic individuals. Twenty-nine percent (187/657) of the patients participated in at least one study of any kind. Multivariate analysis indicated that the strongest predictors of any research participation (including diagnostic, pathogenesis, drug trial, or survey studies) are clinical (including nadir CD4 count [odds ratio {OR} = 0.132, p percentage of appointments kept [OR = 1.022, p service use shown by these groups that may influence research participation. To attract under researched populations, attention should shift from the "who" of research participation to the "how" of clinical interactions.

  20. Clinical research of juvenile hyperthyroidism treatment with radioiodine

    International Nuclear Information System (INIS)

    Qiu Ling; Zhang Chunying; Chen Yue

    2001-01-01

    Objective: To evaluate the effects and side effects in the radioiodine management of juvenile hyperthyroidism. Methods: 80 patients with poor effects using anti-thyroid drug were assigned to receive 131 I therapy. The follows of therapy outcome were assessed 1, 3, 6 and 12 months after the start of treatment. One follows up per 1-3 years. Results: Among 80 patients followed by 6 months, clinical response was excellent in 65 patients (81%), good in 15 (19%). There were 12 patients with hypothyroidism followed 4 years, and with no other side effects. Conclusion: The good therapeutic effect was obtained in radioiodine treatment for juvenile hyperthyroidism. Radioiodine was effective to juvenile hyperthyroidism

  1. [Application of Delphi method in traditional Chinese medicine clinical research].

    Science.gov (United States)

    Bi, Ying-fei; Mao, Jing-yuan

    2012-03-01

    In recent years, Delphi method has been widely applied in traditional Chinese medicine (TCM) clinical research. This article analyzed the present application situation of Delphi method in TCM clinical research, and discussed some problems presented in the choice of evaluation method, classification of observation indexes and selection of survey items. On the basis of present application of Delphi method, the author analyzed the method on questionnaire making, selection of experts, evaluation of observation indexes and selection of survey items. Furthermore, the author summarized the steps of application of Delphi method in TCM clinical research.

  2. Integrating Bioethics into Clinical and Translational Science Research: A Roadmap

    Science.gov (United States)

    Shapiro, Robyn S.; Layde, Peter M.

    2008-01-01

    Abstract Recent initiatives to improve human health emphasize the need to effectively and appropriately translate new knowledge gleaned from basic biomedical and behavioral research to clinical and community application. To maximize the beneficial impact of scientific advances in clinical practice and community health, and to guard against potential deleterious medical and societal consequences of such advances, incorporation of bioethics at each stage of clinical and translational science research is essential. At the earliest stage, bioethics input is critical to address issues such as whether to limit certain areas of scientific inquiry. Subsequently, bioethics input is important to assure not only that human subjects trials are conducted and reported responsibly, but also that results are incorporated into clinical and community practices in a way that promotes and protects bioethical principles. At the final stage of clinical and translational science research, bioethics helps to identify the need and approach for refining clinical practices when safety or other concerns arise. The framework we present depicts how bioethics interfaces with each stage of clinical and translational science research, and suggests an important research agenda for systematically and comprehensively assuring bioethics input into clinical and translational science initiatives. PMID:20443821

  3. 76 FR 24974 - Joint Biomedical Laboratory Research and Development and Clinical Science Research and...

    Science.gov (United States)

    2011-05-03

    ... Science Research and Development Services Scientific Merit Review Board; Notice of Meeting Amendment The... and Clinical Science Research and Development Services Scientific Merit Review Board have been..., behavioral and clinical science research. The panel meetings will be open to the public for approximately one...

  4. 76 FR 79273 - Joint Biomedical Laboratory Research and Development and Clinical Science Research and...

    Science.gov (United States)

    2011-12-21

    ... Science Research and Development Services Scientific Merit Review Board Panel for Eligibility, Notice of... and Clinical Science Research and Development Services Scientific Merit Review Board will meet on... medical specialties within the general areas of biomedical, behavioral, and clinical science research. The...

  5. Clinical Research Informatics for Big Data and Precision Medicine.

    Science.gov (United States)

    Weng, C; Kahn, M G

    2016-11-10

    To reflect on the notable events and significant developments in Clinical Research Informatics (CRI) in the year of 2015 and discuss near-term trends impacting CRI. We selected key publications that highlight not only important recent advances in CRI but also notable events likely to have significant impact on CRI activities over the next few years or longer, and consulted the discussions in relevant scientific communities and an online living textbook for modern clinical trials. We also related the new concepts with old problems to improve the continuity of CRI research. The highlights in CRI in 2015 include the growing adoption of electronic health records (EHR), the rapid development of regional, national, and global clinical data research networks for using EHR data to integrate scalable clinical research with clinical care and generate robust medical evidence. Data quality, integration, and fusion, data access by researchers, study transparency, results reproducibility, and infrastructure sustainability are persistent challenges. The advances in Big Data Analytics and Internet technologies together with the engagement of citizens in sciences are shaping the global clinical research enterprise, which is getting more open and increasingly stakeholder-centered, where stakeholders include patients, clinicians, researchers, and sponsors.

  6. Cellular Therapies Clinical Research Roadmap: lessons learned on how to move a cellular therapy into a clinical trial.

    Science.gov (United States)

    Ouseph, Stacy; Tappitake, Darah; Armant, Myriam; Wesselschmidt, Robin; Derecho, Ivy; Draxler, Rebecca; Wood, Deborah; Centanni, John M

    2015-04-01

    A clinical research roadmap has been developed as a resource for researchers to identify critical areas and potential pitfalls when transitioning a cellular therapy product from the research laboratory, by means of an Investigational New Drug (IND) application, into early-phase clinical trials. The roadmap describes four key areas: basic and preclinical research, resource development, translational research and Good Manufacturing Practice (GMP) and IND assembly and submission. Basic and preclinical research identifies a new therapeutic concept and demonstrates its potential value with the use of a model of the relevant disease. During resource development, the appropriate specialists and the required expertise to bring this product into the clinic are identified (eg, researchers, regulatory specialists, GMP manufacturing staff, clinicians and clinical trials staff, etc). Additionally, the funds required to achieve this goal (or a plan to procure them) are identified. In the next phase, the plan to translate the research product into a clinical-grade therapeutic is developed. Finally regulatory approval to start the trial must be obtained. In the United States, this is done by filing an IND application with the Food and Drug Administration. The National Heart, Lung and Blood Institute-funded Production Assistance for Cellular Therapies program has facilitated the transition of a variety of cellular therapy products from the laboratory into Phase1/2 trials. The five Production Assistance for Cellular Therapies facilities have assisted investigators by performing translational studies and GMP manufacturing to ensure that cellular products met release specifications and were manufactured safely, reproducibly and at the appropriate scale. The roadmap resulting from this experience is the focus of this article. Copyright © 2015 International Society for Cellular Therapy. Published by Elsevier Inc. All rights reserved.

  7. Challenges in Measuring Benefit of Clinical Research Training Programs--the ASH Clinical Research Training Institute Example.

    Science.gov (United States)

    Sung, Lillian; Crowther, Mark; Byrd, John; Gitlin, Scott D; Basso, Joe; Burns, Linda

    2015-12-01

    The American Society of Hematology developed the Clinical Research Training Institute (CRTI) to address the lack of training in patient-oriented research among hematologists. As the program continues, we need to consider metrics for measuring the benefits of such a training program. This article addresses the benefits of clinical research training programs. The fundamental and key components are education and mentorship. However, there are several other benefits including promotion of collaboration, job and advancement opportunities, and promotion of work-life balance. The benefits of clinical research training programs need to be measured so that funders and society can judge if they are worth the investment in time and resources. Identification of elements that are important to program benefit is essential to measuring the benefit of the program as well as program planning. Future work should focus on the constructs which contribute to benefits of clinical research training programs such as CRTI.

  8. Comparative audit of clinical research in pediatric neurology.

    Science.gov (United States)

    Al-Futaisi, Amna; Shevell, Michael

    2004-11-01

    Clinical research involves direct observation or data collection on human subjects. This study was conducted to evaluate the profile of pediatric neurology clinical research over a decade. Trends in pediatric neurology clinical research were documented through a systematic comparative review of articles published in selected journals. Eleven journals (five pediatric neurology, three general neurology, three general pediatrics) were systematically reviewed for articles involving a majority of human subjects less than 18 years of age for the years 1990 and 2000. Three hundred thirty-five clinical research articles in pediatric neurology were identified in the 11 journals for 1990 and 398 for 2000, a 19% increase. A statistically significant increase in analytic design (21.8% vs 39.5%; P = .01), statistical support (6% vs 16.6%; P neurology over a decade. Trends apparently suggest a more rigorous approach to study design and investigation in this field.

  9. Cyclotrons for clinical and biomedical research with PET

    International Nuclear Information System (INIS)

    Wolf, A.P.

    1987-01-01

    The purpose of this commentary is to present some background material on cyclotrons and other particle accelerators particularly with a view toward the considerations behind acquiring and installing such a machine for purely clinical and/or biomedical research use

  10. A proposed clinical research support career pathway for noninvestigators.

    Science.gov (United States)

    Smith, Sheree; Gullick, Janice; Ballard, Jacqueline; Perry, Lin

    2018-03-08

    To discuss the international experience of clinical research support for noninvestigator roles and to propose a new pathway for Australia, to promote a sustainable research support workforce capable of delivering high-quality clinical research. Noninvestigator research support roles are currently characterized by an ad hoc approach to training, with limited role delineation and perceived professional isolation with implications for study completion rates and participant safety. A focused approach to developing and implementing research support pathways has improved patient recruitment, study completion, job satisfaction, and research governance. The Queensland and New South Wales state-based Nurses' Awards, the Australian Qualifications Framework, and a University Professional (Research) Staff Award. Research nurses in the clinical environment improve study coordination, adherence to study protocol, patient safety, and clinical care. A career pathway that guides education and outlines position descriptions and skill sets would enhance development of the research support workforce. This pathway could contribute to changing the patient outcomes through coordination and study completion of high-quality research. A wide consultative approach is required to determine a cost-effective and feasible approach to implementation and evaluation of the proposed pathway. © 2018 John Wiley & Sons Australia, Ltd.

  11. Sex differences in health research and clinical guideline development

    NARCIS (Netherlands)

    Keuken, D.G.

    2008-01-01

    In current medical practice, research based evidence is an important foundation for clinical decision making. Clinical practice guidelines are a major instrument for keeping physicians up-to-date about this evidence. In order to provide optimal care to both men and women, it is important that sex

  12. Radioactive isotopes in clinical medicine and research. Abstracts

    International Nuclear Information System (INIS)

    2007-01-01

    The review on the International Symposium on radioactive isotopes in clinical medicine and research in Bad Hofgastein, Austria, 9-12 January 2008, contains 42 papers and 29 poster contributions on the following topics: radiopharmaceutical sciences; radiopharmaceutical sciences in oncology and cardiology; therapy; endocrinology; molecular imaging; clinical PET; physics: image processing; instrumentation, neurology, psychiatry

  13. The clinical research office of the endourological society audit committee

    NARCIS (Netherlands)

    Preminger, G.M.; Alken, P.; Habuchi, T.; Wijkstra, H.; Skolarikos, A.; Yin, C.-J.

    2011-01-01

    The Clinical Research Office of the Endourological Society (CROES) conducts large-scale, international, multicenter clinical trials in the field of endourology. One of the major challenges that these trials pose is to ensure that data collected remotely and online within a very short time frame are

  14. Key factors in children's competence to consent to clinical research

    NARCIS (Netherlands)

    Hein, Irma M.; Troost, Pieter W.; Lindeboom, Robert; Benninga, Marc A.; Zwaan, C. Michel; van Goudoever, Johannes B.; Lindauer, Ramón J. L.

    2015-01-01

    Although law is established on a strong presumption that persons younger than a certain age are not competent to consent, statutory age limits for asking children's consent to clinical research differ widely internationally. From a clinical perspective, competence is assumed to involve many factors

  15. The National Institute of Dental Research Clinical Dental Staff Fellowship.

    Science.gov (United States)

    Baum, Bruce J.; And Others

    1988-01-01

    A program in one of the National Institutes of Health offers clinical training fellowships as a means of training potential dental school faculty by providing both unique clinical skills and high-quality research experience. The program was developed in response to a perceived need for change in academic dentistry. (MSE)

  16. Radioactive isotopes in clinical medicine and research. Abstracts

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2007-07-01

    The review on the International Symposium on radioactive isotopes in clinical medicine and research in Bad Hofgastein, Austria, 9-12 January 2008, contains 42 papers and 29 poster contributions on the following topics: radiopharmaceutical sciences; radiopharmaceutical sciences in oncology and cardiology; therapy; endocrinology; molecular imaging; clinical PET; physics: image processing; instrumentation, neurology, psychiatry.

  17. Infrastructure resources for clinical research in amyotrophic lateral sclerosis.

    Science.gov (United States)

    Sherman, Alexander V; Gubitz, Amelie K; Al-Chalabi, Ammar; Bedlack, Richard; Berry, James; Conwit, Robin; Harris, Brent T; Horton, D Kevin; Kaufmann, Petra; Leitner, Melanie L; Miller, Robert; Shefner, Jeremy; Vonsattel, Jean Paul; Mitsumoto, Hiroshi

    2013-05-01

    Clinical trial networks, shared clinical databases, and human biospecimen repositories are examples of infrastructure resources aimed at enhancing and expediting clinical and/or patient oriented research to uncover the etiology and pathogenesis of amyotrophic lateral sclerosis (ALS), a rapidly progressive neurodegenerative disease that leads to the paralysis of voluntary muscles. The current status of such infrastructure resources, as well as opportunities and impediments, were discussed at the second Tarrytown ALS meeting held in September 2011. The discussion focused on resources developed and maintained by ALS clinics and centers in North America and Europe, various clinical trial networks, U.S. government federal agencies including the National Institutes of Health (NIH), the Agency for Toxic Substances and Disease Registry (ATSDR) and the Centers for Disease Control and Prevention (CDC), and several voluntary disease organizations that support ALS research activities. Key recommendations included 1) the establishment of shared databases among individual ALS clinics to enhance the coordination of resources and data analyses; 2) the expansion of quality-controlled human biospecimen banks; and 3) the adoption of uniform data standards, such as the recently developed Common Data Elements (CDEs) for ALS clinical research. The value of clinical trial networks such as the Northeast ALS (NEALS) Consortium and the Western ALS (WALS) Consortium was recognized, and strategies to further enhance and complement these networks and their research resources were discussed.

  18. Features of TMR for a Successful Clinical and Research Database

    OpenAIRE

    Pryor, David B.; Stead, William W.; Hammond, W. Edward; Califf, Robert M.; Rosati, Robert A.

    1982-01-01

    A database can be used for clinical practice and for research. The design of the database is important if both uses are to succeed. A clinical database must be efficient and flexible. A research database requires consistent observations recorded in a format which permits complete recall of the experience. In addition, the database should be designed to distinguish between missing data and negative responses, and to minimize transcription errors during the recording process.

  19. The summer institute in clinical dental research methods: still going and growing after twenty years.

    Science.gov (United States)

    Derouen, Timothy A; Wiesenbach, Carol

    2012-11-01

    The first Summer Institute in Clinical Dental Research Methods, a faculty development program at the University of Washington, was offered in the summer of 1992 for sixteen participants. The primary objective of the program was to give clinical faculty members in dentistry an introduction to and an understanding of the fundamental principles and methods used in good clinical research. In the twentieth offering of the institute in 2011, there were thirty-five participants, and over the twenty institutes, there has been a cumulative total of 463 participants who have come from thirty U.S. states as well as forty-three countries outside the United States. The curriculum has expanded from the initial offering of biostatistics, clinical epidemiology, behavioral research methods, and ethics in clinical research to now include clinical trials, grantsmanship, data analysis, an elective in molecular biology, and a team project that provides participants with hands-on experience in research proposal development as members of an interdisciplinary team. Enrollment has doubled since the first year, yet exit evaluations of the program content have remained consistently high (rated as very good to excellent). One of the indicators of program quality is that at least 50 percent of recent participants indicated that they attended because the program was recommended by colleagues who had attended. There seems to be an ever-increasing pool of dental faculty members who are eager to learn more about clinical research methodology through the institute despite the intensive demands of full-time participation in a six-week program.

  20. Clinical diabetes research using data mining: a Canadian perspective.

    Science.gov (United States)

    Shah, Baiju R; Lipscombe, Lorraine L

    2015-06-01

    With the advent of the digitization of large amounts of information and the computer power capable of analyzing this volume of information, data mining is increasingly being applied to medical research. Datasets created for administration of the healthcare system provide a wealth of information from different healthcare sectors, and Canadian provinces' single-payer universal healthcare systems mean that data are more comprehensive and complete in this country than in many other jurisdictions. The increasing ability to also link clinical information, such as electronic medical records, laboratory test results and disease registries, has broadened the types of data available for analysis. Data-mining methods have been used in many different areas of diabetes clinical research, including classic epidemiology, effectiveness research, population health and health services research. Although methodologic challenges and privacy concerns remain important barriers to using these techniques, data mining remains a powerful tool for clinical research. Copyright © 2015 Canadian Diabetes Association. Published by Elsevier Inc. All rights reserved.

  1. Pharmaceutical advertisements in medical journals received in a medical clinic: are we having "too much of a good thing"?

    Science.gov (United States)

    Lohiya, Sapna

    2005-05-01

    A convenience sample of all medical journals found in a medical clinic was reviewed for pharmaceutical advertisements. Ads were present in 25 (96%) of the 26 journals. Ad space varied from 0-34% (mean 12) in research, and 9-48% (mean: 36) in nonresearch journals. In 23 (88%) journals, individual ads consisted of more than one page. Colorful glossy insert-ads, of up to nine pages, were seen in 18 (69%) journals. Six (23%) journals contained more advertising than editorial pages. Many ads were longer than the longest article in that journal. Medical journals devote considerable space to pharmaceutical ads. Excessive pharmaceutical advertising may bias the journals' owners and readers and may be distracting and annoying.

  2. The UK clinical research network - has it been a success for dermatology clinical trials?

    OpenAIRE

    Charlesworth Lisa; Perdue Jo; Foster Katharine; Koller Karin; Thomas Kim S; Chalmers Joanne R

    2011-01-01

    Abstract Background Following the successful introduction of five topic-specific research networks in the UK, the Comprehensive Local Research Network (CLRN) was established in 2008 in order to provide a blanket level of support across the whole country regardless of the clinical discipline. The role of the CLRN was to facilitate recruitment into clinical trials, and to encourage greater engagement in research throughout the National Health Service (NHS). Methods This report evaluates the imp...

  3. Effects of Disclosing Financial Interests on Attitudes Toward Clinical Research

    Science.gov (United States)

    Hall, Mark A.; Dinan, Michaela A.; DePuy, Venita; Friedman, Joëlle Y.; Allsbrook, Jennifer S.; Sugarman, Jeremy

    2008-01-01

    Background The effects of disclosing financial interests to potential research participants are not well understood. Objective To examine the effects of financial interest disclosures on potential research participants’ attitudes toward clinical research. Design and Participants Computerized experiment conducted with 3,623 adults in the United States with either diabetes mellitus or asthma, grouped by lesser and greater severity. Respondents read a description of a hypothetical clinical trial relevant to their diagnosis that included a financial disclosure statement. Respondents received 1 of 5 disclosure statements. Measurements Willingness to participate in the hypothetical clinical trial, relative importance of information about the financial interest, change in trust after reading the disclosure statement, surprise regarding the financial interest, and perceived effect of the financial interest on the quality of the clinical trial. Results Willingness to participate in the hypothetical clinical trial did not differ substantially among the types of financial disclosures. Respondents viewed the disclosed information as less important than other factors in deciding to participate. Disclosures were associated with some respondents trusting the researchers less, although trust among some respondents increased. Most respondents were not surprised to learn of financial interests. Researchers owning equity were viewed as more troubling than researchers who were compensated for the costs of research through per capita payments. Conclusions Aside from a researcher holding an equity interest, the disclosure to potential research participants of financial interests in research, as recommended in recent policies, is unlikely to affect willingness to participate in research. Electronic supplementary material The online version of this article (doi:10.1007/s11606-008-0590-4) contains supplementary material, which is available to authorized users. PMID:18386101

  4. Influences upon pediatricians’ willingness to refer patients to clinical research

    Directory of Open Access Journals (Sweden)

    Jeanne Dalen

    2010-03-01

    Full Text Available Jeanne Dalen1, Robert D Annett2, Janet L Brody1, Mandy L Perryman31Center for Family and Adolescent Research, Oregon Research Institute, Portland, OR, USA; 2University of New Mexico Health Sciences Center, Albuquerque, NM, USA; 3School of Education and Human Development, Lynchburg College, Lynchburg, UA, USAPurpose: The purpose of this brief report is to determine factors that influence the willingness of pediatricians to refer their patients to clinical research and to explore the relationship between pediatrician characteristics and self-reported number of patients referred to clinical research.Method: Forty-three pediatricians from an academic pediatrics department of a university children’s hospital in Albuquerque, New Mexico rated how influential 10 reasons would be in their decision to refer a patient to pediatric clinical research.Results: Differences among the influences for pediatrician referral to research were observed. The most influential consideration for referral was the scientific merit of the study, followed by patient benefit. Contextual factors and physician compensation were identified as the least important reasons pediatricians refer patients to research. Analyses also revealed significant relationships between referrals made and percentage of time spent in research activities.Conclusions: Pediatricians may be more likely to refer their patients to clinical research studies when they believe the purpose of the study is meaningful to patients as well as to future patient populations. In addition, characteristics of the individual pediatricians may play an important role in actual referral behavior.Keywords: recruitment, clinical research, adolescent research, pediatrician attitudes

  5. US-LA CRN Clinical Cancer Research in Latin America

    Science.gov (United States)

    The United States – Latin America Cancer Research Network (US-LA CRN) convened its Annual Meeting, in coordination with the Ministry of Health of Chile to discuss the Network’s first multilateral clinical research study: Molecular Profiling of Breast Cancer (MPBC).

  6. Feasibility of Conducting Autism Biomarker Research in the Clinical Setting.

    Science.gov (United States)

    Sices, Laura; Pawlowski, Katherine; Farfel, Laura; Phillips, Deirdre; Howe, Yamini; Cochran, David M; Choueiri, Roula; Forbes, Peter W; Brewster, Stephanie J; Frazier, Jean A; Neumeyer, Ann; Bridgemohan, Carolyn

    2017-09-01

    Recruitment and completion of research activities during regular clinical care has the potential to increase research participation in complex neurodevelopmental disorders. We evaluated the feasibility, and effect on clinical care, of conducting biomarker research within a subspecialty clinical visit for autism spectrum disorder (ASD). Children, aged 5 to 10 years, were recruited by providers in ASD clinics at 5 institutions. Biomarkers collected were growth measurements, head circumference, neurologic and dysmorphology examinations, digit ratio (2D:4D) measurement, and platelet serotonin and urinary melatonin sulfate excretion levels. Parents completed the Aberrant Behavior Checklist-Community and a medical/demographic questionnaire. Cognitive level was abstracted from the medical record. Parents and clinicians completed surveys on the effect of the study on the clinical visit. Eighty-three children and their caregivers participated. Factors limiting participation included difficulty reaching families by phone and parent concern about the study blood draw requirement. All children completed at least 4 of 7 planned research activities. Demographic factors, educational placement, and child behavior were not associated with completion of study activities. Lower nonverbal cognitive function was weakly associated with fewer activities completed. Forty-four percent of clinicians reported an effect of the research study on the clinical visit. However, neither parent-reported nor clinician-reported effect was associated with the degree of study activity completion. Recruiting study participants in the context of scheduled ASD clinical visits required significant effort. However, once recruited, participants completed most study activities, regardless of behavioral symptom severity. Research activities did not adversely affect the clinical visit.

  7. Clinical Research Environment in India: Challenges and Proposed Solutions.

    Science.gov (United States)

    Burt, Tal; Sharma, Pooja; Dhillon, Savita; Manchanda, Mukul; Mittal, Sanjay; Trehan, Naresh

    2014-11-01

    India has compelling need and keen aspirations for indigenous clinical research. Notwithstanding this need and previously reported growth the expected expansion of Indian clinical research has not materialized. We reviewed the scientific literature, lay press reports, and ClinicalTrials.gov data for information and commentary on projections, progress, and impediments associated with clinical trials in India. We also propose targeted solutions to identified challenges. The Indian clinical trial sector grew by (+) 20.3% CAGR (compound annual growth rate) between 2005 and 2010 and contracted by (-) 14.6% CAGR between 2010 and 2013. Phase-1 trials grew by (+) 43.5% CAGR from 2005-2013, phase-2 trials grew by (+) 19.8% CAGR from 2005-2009 and contracted by (-) 12.6% CAGR from 2009-2013, and phase-3 trials grew by (+) 13.0% CAGR from 2005-2010 and contracted by (-) 28.8% CAGR from 2010-2013. This was associated with a slowing of the regulatory approval process, increased media coverage and activist engagement, and accelerated development of regulatory guidelines and recuperative initiatives. We propose the following as potential targets for restorative interventions: Regulatory overhaul (leadership and enforcement of regulations, resolution of ambiguity in regulations, staffing, training, guidelines, and ethical principles [e.g., compensation]).Education and training of research professionals, clinicians, and regulators.Public awareness and empowerment. After a peak in 2009-2010, the clinical research sector in India appears to be experiencing a contraction. There are indications of challenges in regulatory enforcement of guidelines; training of clinical research professionals; and awareness, participation, partnership, and the general image amongst the non-professional media and public. Preventative and corrective principles and interventions are outlined with the goal of realizing the clinical research potential in India.

  8. Making good theory practical: five lessons for an Applied Social Identity Approach to challenges of organizational, health, and clinical psychology.

    Science.gov (United States)

    Haslam, S Alexander

    2014-03-01

    Social identity research was pioneered as a distinctive theoretical approach to the analysis of intergroup relations but over the last two decades it has increasingly been used to shed light on applied issues. One early application of insights from social identity and self-categorization theories was to the organizational domain (with a particular focus on leadership), but more recently there has been a surge of interest in applications to the realm of health and clinical topics. This article charts the development of this Applied Social Identity Approach, and abstracts five core lessons from the research that has taken this forward. (1) Groups and social identities matter because they have a critical role to play in organizational and health outcomes. (2) Self-categorizations matter because it is people's self-understandings in a given context that shape their psychology and behaviour. (3) The power of groups is unlocked by working with social identities not across or against them. (4) Social identities need to be made to matter in deed not just in word. (5) Psychological intervention is always political because it always involves some form of social identity management. Programmes that seek to incorporate these principles are reviewed and important challenges and opportunities for the future are identified. © 2014 The British Psychological Society.

  9. In Defense of a Social Value Requirement for Clinical Research.

    Science.gov (United States)

    Wendler, David; Rid, Annette

    2017-02-01

    Many guidelines and commentators endorse the view that clinical research is ethically acceptable only when it has social value, in the sense of collecting data which might be used to improve health. A version of this social value requirement is included in the Declaration of Helsinki and the Nuremberg Code, and is codified in many national research regulations. At the same time, there have been no systematic analyses of why social value is an ethical requirement for clinical research. Recognizing this gap in the literature, recent articles by Alan Wertheimer and David Resnik argue that the extant justifications for the social value requirement are unpersuasive. Both authors conclude, contrary to almost all current guidelines and regulations, that it can be acceptable across a broad range of cases to conduct clinical research which is known prospectively to have no social value. The present article assesses this conclusion by critically evaluating the ethical and policy considerations relevant to the claim that clinical research must have social value. This analysis supports the standard view that social value is an ethical requirement for the vast majority of clinical research studies and should be mandated by applicable guidelines and policies. © 2017 John Wiley & Sons Ltd.

  10. MedAustron – Non-Clinical Research Opportunities

    International Nuclear Information System (INIS)

    Schreiner, T.

    2013-01-01

    MedAustron is a synchrotron based light-ion beam therapy centre for cancer treatment as well as for clinical and non-clinical research, currently in the construction phase in Wiener Neustadt. Whilst the choice of basic machine parameters was driven by medical requirements, the accelerator complex design was also optimised to offer flexibility for research operation. The potential of the synchrotron is being exploited to increase the maximum proton energy far beyond the medical needs to up to 800 MeV, for experimental physics applications, mainly in the areas of proton scattering and detector research. The accelerator layout allows for the installation of up to four ion source-spectrometer units, to provide various ion types besides the clinical used protons and carbon ions. To decouple research and medical operation, a dedicated irradiation room for non-clinical research was included providing two isocentres for the installation of different experiments. This presentation provides a status overview over the whole project and highlights the non-clinical research opportunities at MedAustron. (author)

  11. The relevance of qualitative research for clinical programs in psychiatry.

    Science.gov (United States)

    Goering, Paula; Boydell, Katherine M; Pignatiello, Antonio

    2008-03-01

    It is time to move beyond education about qualitative research theory and methods to using them to understand and improve psychiatric practice. There is a good fit between this agenda and current thinking about research use that broadens definitions of evidence beyond the results of experiments. This paper describes a qualitative program evaluation to illustrate what kind of useful knowledge is generated and how it can be created through a clinician-researcher partnership. The linkage and exchange model of effective knowledge translation described involves interaction between clinicians and researchers throughout the research process and results in mutual learning through the planning, disseminating, and application of existing or new qualitative research in decision making.

  12. 'Nursing research culture' in the context of clinical nursing practice

    DEFF Research Database (Denmark)

    Bøttcher Berthelsen, Connie; Hølge-Hazelton, Bibi

    2017-01-01

    for efficiency, nurses’ barriers to research use and the lack of definition of the concept of nursing research culture make it difficult to establish. Design Concept analysis. Data sources Data were collected through a literature review in PubMed, CINAHL and PsycINFO during March 2016. Methods Walker and Avant......Aim To report an analysis of the concept of nursing research culture in the context of clinical nursing practice. Background Nursing research culture should be valued for its contribution to improving patient care and should be considered as a routine hospital activity. However, the demand......'s eight-step framework for concept analysis. Results Five defining attributes of nursing research culture in the context of clinical nursing practice were identified: strong monodisciplinary nursing professionalism, academic thinking and socialization, research use as a part of daily nursing practice...

  13. Small animal MRI: clinical MRI as an interface to basic biomedical research

    International Nuclear Information System (INIS)

    Pinkernelle, J.G.; Stelter, L.; Hamm, B.; Teichgraeber, U.

    2008-01-01

    The demand for highly resolved small animal MRI for the purpose of biomedical research has increased constantly. Dedicated small animal MRI scanners working at ultra high field strengths from 4.7 to 7.0 T and even above are MRI at its best. However, using high resolution RF coils in clinical scanners up to 3.0 T, small animal MRI can achieve highly resolved images showing excellent tissue contrast. In fact, in abundant experimental studies, clinical MRI is used for small animal imaging. Mostly clinical RF coils in the single-loop design are applied. In addition, custom-built RF coils and even gradient inserts are used in a clinical scanner. For the reduction of moving artifacts, special MRI-compatible animal ECG und respiration devices are available. In conclusion, clinical devices offer broad availability, are less expense in combination with good imaging performance and provide a translational nature of imaging results. (orig.)

  14. Guidance for Researchers Developing and Conducting Clinical Trials in Practice-based Research Networks (PBRNs)

    Science.gov (United States)

    Dolor, Rowena J.; Schmit, Kristine M.; Graham, Deborah G.; Fox, Chester H.; Baldwin, Laura Mae

    2015-01-01

    Background There is increased interest nationally in multicenter clinical trials to answer questions about clinical effectiveness, comparative effectiveness, and safety in real-world community settings. Primary care practice-based research networks (PBRNs), comprising community- and/or academically affiliated practices committed to improving medical care for a range of health problems, offer ideal settings for these trials, especially pragmatic clinical trials. However, many researchers are not familiar with working with PBRNs. Methods Experts in practice-based research identified solutions to challenges that researchers and PBRN personnel experience when collaborating on clinical trials in PBRNs. These were organized as frequently asked questions in a draft document presented at a 2013 Agency for Health care Research and Quality PBRN conference workshop, revised based on participant feedback, then shared with additional experts from the DARTNet Institute, Clinical Translational Science Award PBRN, and North American Primary Care Research Group PBRN workgroups for further input and modification. Results The “Toolkit for Developing and Conducting Multi-site Clinical Trials in Practice-Based Research Networks” offers guidance in the areas of recruiting and engaging practices, budgeting, project management, and communication, as well as templates and examples of tools important in developing and conducting clinical trials. Conclusion Ensuring the successful development and conduct of clinical trials in PBRNs requires a highly collaborative approach between academic research and PBRN teams. PMID:25381071

  15. [The future of clinical research: why do we need an ecological approach?].

    Science.gov (United States)

    Liberati, Alessandro; Moja, Lorenzo P; Moschetti, Ivan

    2006-11-01

    In this paper we try to define the future goals of the clinical research, with particular reference to methodological and policy issues. There is an increasing tension between the real drivers of clinical research and its scientific and ethical aims. To consumers the goal is to strengthen the relevance and usefulness of clinical research. This is possible only if consumers are empowered and actively involved. For the health care systems it is mandatory to re-engineer the process, enforcing national and international legislation. This should help to fill the research-clinical practice gap and to balance the research agenda, better reflecting health priorities. Finally the scientific community should reflect on its own conflicts of interests and analyse the causes of the ethical divide between the needs and the market. Scientists too often seem to loose sight of the original cumulative nature of research and of the idea of research as a collective good. More non-commercial research is needed, integrated with the health care systems, to support a transparent, more realistic and valid information useful for patient care, scientific information.

  16. The UK clinical research network--has it been a success for dermatology clinical trials?

    Science.gov (United States)

    Thomas, Kim S; Koller, Karin; Foster, Katharine; Perdue, Jo; Charlesworth, Lisa; Chalmers, Joanne R

    2011-06-16

    Following the successful introduction of five topic-specific research networks in the UK, the Comprehensive Local Research Network (CLRN) was established in 2008 in order to provide a blanket level of support across the whole country regardless of the clinical discipline. The role of the CLRN was to facilitate recruitment into clinical trials, and to encourage greater engagement in research throughout the National Health Service (NHS). This report evaluates the impact of clinical research networks in supporting clinical trials in the UK, with particular reference to our experiences from two non-commercial dermatology trials. It covers our experience of engaging with the CLRN (and other research networks) using two non-commercial dermatology trials as case studies. We present the circumstances that led to our approach to the research networks for support, and the impact that this support had on the delivery of these trials. In both cases, recruitment was boosted considerably following the provision of additional support, although other factors such as the availability of experienced personnel, and the role of advertising and media coverage in promoting the trials were also important in translating this additional resource into increased recruitment. Recruitment into clinical trials is a complex task that can be influenced by many factors. A world-class clinical research infrastructure is now in place in England (with similar support available in Scotland and Wales), and it is the responsibility of the research community to ensure that this unique resource is used effectively and responsibly.

  17. Danish research-active clinical nurses overcome barriers in research utilization.

    Science.gov (United States)

    Adamsen, Lis; Larsen, Kristian; Bjerregaard, Lene; Madsen, Jan K

    2003-03-01

    The aim of this study was to examine whether there was a difference between clinical nurses who were research-active, and clinical nurses who were nonresearch-active in utilization of research. A further aim was to identify the most significant barriers faced by a group of Danish clinical nurses in their use of research. Discrepancy between the improved quality of research results and the lack of implementing them was the starting point for a series of studies which showed the types of barriers clinical nurses found especially cumbersome when applying the research results of other researchers. This study investigates whether the clinical nurses' own engagement in research had any impact on their perception of research utilization. The study had an exploratory and descriptive design. Seventy-nine Danish clinical nurses participated and semi-structured interviewing was used as the research method. There was a statistically significant difference between the research-active and nonresearch-active nurses on various variables. The study showed that, to a larger extent, research-active nurses used evidence-based knowledge and were generally more internationally orientated. Furthermore, two important barriers for research utilization were identified by all 79 clinical nurses included in the study, i.e. 90% of the nurses explained that the quantity of research results was overwhelming, and 75% of them found that they were unable to evaluate the quality of the research. Clinical nurses, who were research-active themselves, experienced more success in overcoming some of the barriers, which existed in applying research to practice. The research potential found amongst clinical nurses in Denmark needed to be further supported through training and guidance in research methodology, establishing introductory stipends and part-time research positions. By doing so, some of the barriers affecting research utilization and the so-called theory-practice gap might be reduced. Further

  18. Good questions require good answers. Critics on current climate research contradicted; Goede vragen vereisen goede antwoorden. Kritiek op gangbaar klimaatonderzoek weersproken

    Energy Technology Data Exchange (ETDEWEB)

    Vellinga, P. [Milieuwetenschappen, Vrije Universiteit, Amsterdam (Netherlands); Van Dorland, R. [KNMI, De Bilt (Netherlands); Kabat, P. [Aardsystemen en Klimaatstudies, Wageningen Universiteit, Wageningen (Netherlands)

    2008-07-01

    In some of the previous issues of this magazine (Spil 2007, issue 4 and 5-6, and Spil 2008, issue 1) the authors Labohm, Roersch and Thoenes started a frontal attack of the greenhouse theory and the researchers who report on the state of science in the framework of the IPCC. The author of this article addresses two main questions arising from the above-mentioned authors: (1) Does the use of fossil fuels affect global climate?; and (2) Is the warming of the last 30 years related to the increasing concentrations of greenhouse gases in the atmosphere? [mk]. [Dutch] In enkele vorige afleveringen van dit tijdschrift (Spil 2007, nummers 4 en 5-6, en Spil 2008, nummer 1) hebben de auteurs Labohm, Roersch en Thoenes een frontale aanval ingezet op de broeikastheorie en de onderzoekers die in IPCC-verband verslag doen van de stand van de wetenschap. De auteur van dit artikel gaat in op twee door voornoemde auteurs gestelde hoofdvragen: (1) Heeft het gebruik van fossiele brandstoffen invloed op het wereldklimaat?; en (2) Houdt de opwarming van de laatste dertig jaar verband met de gestegen concentraties van broeikasgassen in de atmosfeer?.

  19. The STAR Data Reporting Guidelines for Clinical High Altitude Research.

    Science.gov (United States)

    Brodmann Maeder, Monika; Brugger, Hermann; Pun, Matiram; Strapazzon, Giacomo; Dal Cappello, Tomas; Maggiorini, Marco; Hackett, Peter; Bärtsch, Peter; Swenson, Erik R; Zafren, Ken

    2018-03-01

    Brodmann Maeder, Monika, Hermann Brugger, Matiram Pun, Giacomo Strapazzon, Tomas Dal Cappello, Marco Maggiorini, Peter Hackett, Peter Baärtsch, Erik R. Swenson, Ken Zafren (STAR Core Group), and the STAR Delphi Expert Group. The STARdata reporting guidelines for clinical high altitude research. High AltMedBiol. 19:7-14, 2018. The goal of the STAR (STrengthening Altitude Research) initiative was to produce a uniform set of key elements for research and reporting in clinical high-altitude (HA) medicine. The STAR initiative was inspired by research on treatment of cardiac arrest, in which the establishment of the Utstein Style, a uniform data reporting protocol, substantially contributed to improving data reporting and subsequently the quality of scientific evidence. The STAR core group used the Delphi method, in which a group of experts reaches a consensus over multiple rounds using a formal method. We selected experts in the field of clinical HA medicine based on their scientific credentials and identified an initial set of parameters for evaluation by the experts. Of 51 experts in HA research who were identified initially, 21 experts completed both rounds. The experts identified 42 key parameters in 5 categories (setting, individual factors, acute mountain sickness and HA cerebral edema, HA pulmonary edema, and treatment) that were considered essential for research and reporting in clinical HA research. An additional 47 supplemental parameters were identified that should be reported depending on the nature of the research. The STAR initiative, using the Delphi method, identified a set of key parameters essential for research and reporting in clinical HA medicine.

  20. Using the Nine Common Themes of Good Practice checklist as a tool for evaluating the research priority setting process of a provincial research and program evaluation program.

    Science.gov (United States)

    Mador, Rebecca L; Kornas, Kathy; Simard, Anne; Haroun, Vinita

    2016-03-23

    Given the context-specific nature of health research prioritization and the obligation to effectively allocate resources to initiatives that will achieve the greatest impact, evaluation of priority setting processes can refine and strengthen such exercises and their outcomes. However, guidance is needed on evaluation tools that can be applied to research priority setting. This paper describes the adaption and application of a conceptual framework to evaluate a research priority setting exercise operating within the public health sector in Ontario, Canada. The Nine Common Themes of Good Practice checklist, described by Viergever et al. (Health Res Policy Syst 8:36, 2010) was used as the conceptual framework to evaluate the research priority setting process developed for the Locally Driven Collaborative Projects (LDCP) program in Ontario, Canada. Multiple data sources were used to inform the evaluation, including a review of selected priority setting approaches, surveys with priority setting participants, document review, and consultation with the program advisory committee. The evaluation assisted in identifying improvements to six elements of the LDCP priority setting process. The modifications were aimed at improving inclusiveness, information gathering practices, planning for project implementation, and evaluation. In addition, the findings identified that the timing of priority setting activities and level of control over the process were key factors that influenced the ability to effectively implement changes. The findings demonstrate the novel adaptation and application of the 'Nine Common Themes of Good Practice checklist' as a tool for evaluating a research priority setting exercise. The tool can guide the development of evaluation questions and enables the assessment of key constructs related to the design and delivery of a research priority setting process.

  1. Patient-Reported Outcome and Observer-Reported Outcome Assessment in Rare Disease Clinical Trials: An ISPOR COA Emerging Good Practices Task Force Report.

    Science.gov (United States)

    Benjamin, Katy; Vernon, Margaret K; Patrick, Donald L; Perfetto, Eleanor; Nestler-Parr, Sandra; Burke, Laurie

    Rare diseases (RDs) affect a small number of people within a population. About 5000 to 8000 distinct RDs have been identified, with an estimated 6% to 8% of people worldwide suffering from an RD. Approximately 75% of RDs affect children. Frequently, these conditions are heterogeneous; many are progressive. Regulatory incentives have increased orphan drug designations and approvals. To develop emerging good practices for RD outcomes research addressing the challenges inherent in identifying, selecting, developing, adapting, and implementing patient-reported outcome (PRO) and observer-reported outcome (ObsRO) assessments for use in RD clinical trials. This report outlines the challenges and potential solutions in determining clinical outcomes for RD trials. It follows the US Food and Drug Administration Roadmap to Patient-Focused Outcome Measurement in Clinical Trials. The Roadmap consists of three columns: 1) Understanding the Disease or Condition, 2) Conceptualizing Treatment Benefit, and 3) Selecting/Developing the Outcome Measure. Challenges in column 1 include factors such as incomplete natural history data and heterogeneity of disease presentation and patient experience. Solutions include using several information sources, for example, clinical experts and patient advocacy groups, to construct the condition's natural history and understand treatment patterns. Challenges in column 2 include understanding and measuring treatment benefit from the patient's perspective, especially given challenges in defining the context of use such as variations in age or disease severity/progression. Solutions include focusing on common symptoms across patient subgroups, identifying short-term outcomes, and using multiple types of COA instruments to measure the same constructs. Challenges in column 3 center around the small patient population and heterogeneity of the condition or study sample. Few disease-specific instruments for RDs exist. Strategies include adapting existing

  2. Physician participation in clinical research and trials: issues and approaches

    Directory of Open Access Journals (Sweden)

    Sami F Shaban

    2011-03-01

    Full Text Available Sayeeda Rahman1, Md Anwarul Azim Majumder1, Sami F Shaban2, Nuzhat Rahman3, Moslehuddin Ahmed4, Khalid Bin Abdulrahman5, Urban JA D’Souza61Department of Clinical Sciences, School of Life Sciences, University of Bradford, West Yorkshire, Bradford, UK; 2Department of Medical Education, Faculty of Medicine and Health Sciences, UAE University, Al-Ain, United Arab Emirates; 3Department of Nutrition Sciences, University of Alabama at Birmingham, Birmingham, AL, USA; 4Department of Community Medicine, Uttara Adhunik Medical College, Dhaka, Bangladesh; 5Department of Family Medicine and Medical Education, College of Medicine, Al-Imam University, Riyadh, Saudi Arabia; 6Department of Post Graduate Studies, School of Medicine, University Malaysia Sabah, Kota Kinabalu, Sabah, MalaysiaAbstract: The rapid development of new drugs, therapies, and devices has created a dramatic increase in the number of clinical research studies that highlights the need for greater participation in research by physicians as well as patients. Furthermore, the potential of clinical research is unlikely to be reached without greater participation of physicians in research. Physicians face a variety of barriers with regard to participation in clinical research. These barriers are system- or organization-related as well as research- and physician-related. To encourage physician participation, appropriate organizational and operational infrastructures are needed in health care institutes to support research planning and management. All physicians should receive education and training in the fundamentals of research design and methodology, which need to be incorporated into undergraduate medical education and postgraduate training curricula and then reinforced through continuing medical education. Medical schools need to analyze current practices of teaching–learning and research, and reflect upon possible changes needed to develop a ‘student-focused teaching–learning and

  3. Auditing of clinical research ethics in a children's and women's academic hospital.

    Science.gov (United States)

    Bortolussi, Robert; Nicholson, Diann

    2002-06-01

    Canadian and international guidelines for research ethics practices have advocated that research ethics boards (REBs) should implement mechanisms to review and monitor human research. Despite this, few Canadian REBs fulfil this expectation. The objective of this report is to summarize the results of 6 audits of clinical research ethics conducted between 1992 and 2000 in a children's and women's academic hospital in Canada in an effort to guide other academic centres planning a similar process. Research audits were conducted by members of a research audit review committee made up of REB volunteers. With use of random and selective processes, approximately 10% of research protocols were audited through interviews with research investigators and research coordinators and by sampling research records. Predetermined criteria were used to assess evidence of good record keeping, data monitoring, adherence to protocol, consents and the recording of adverse events during the research study. An estimate of time required to undertake an audit was made by recall of participants and records. Thirty-five research studies were reviewed including 16 multicentre clinical trials and 19 single-site clinical studies. Review of record keeping and research practice revealed some deficiencies: researchers failed to maintain original authorization (7%) or renewal documentation (9%); there was 1 instance of improper storage of medication; in 5% of 174 participants for whom consent was reviewed, an outdated consent form had been used, and in 4% the signature of the enrolee was not properly shown. Other deficiencies in consent documentation occurred in less than 2% of cases. Nineteen recommendations were made with respect to deficiencies and process issues. A total of 9 to 20 person-hours are required to review each protocol in a typical audit of this type. Information from research audits has been useful to develop educational programs to correct deficiencies identified through the audits

  4. Exploring the value of qualitative research films in clinical education.

    Science.gov (United States)

    Toye, Fran; Jenkins, Sue; Seers, Kate; Barker, Karen

    2015-11-27

    Many healthcare professionals use both quantitative and qualitative research to inform their practice. The usual way to access research findings is through peer-reviewed publications. This study aimed to understand the impact on healthcare professionals of watching and discussing a short research based film. The film, 'Struggling to be me' portrays findings from a qualitative synthesis exploring people's experiences of chronic pain, and was delivered as part of an inter-professional postgraduate e-learning module. The innovation of our study is to be the first to explore the impact of qualitative research portrayed through the medium of film in clinical education. All nineteen healthcare professionals enrolled on the course in December 2013 took part in on-line interviews or focus groups. We recorded and transcribed the interviews verbatim and used the methods of Grounded Theory to analyse the interview transcripts. Watching and discussing the film became a stimulus for learning : (a) A glimpse beneath the surface explored a pro-active way of seeing the person behind the pain (b) Pitfalls of the Medical Model recognised the challenge, for both patient and clinician, of 'sitting with' rather than 'fixing' an ill person; (c) Feeling bombarded by despair acknowledged the intense emotions that the clinicians brings to the clinical encounter; (d) Reconstructing the clinical encounter as a shared journey reconstructed the time-constrained clinical encounter as a single step on a shared journey towards healing, rather than fixing. Films portraying qualitative research findings can stimulate a pro-active and dialectic form of knowing. Research-based qualitative films can make qualitative findings accessible and can be a useful resource in clinical training. Our research presents, for the first time, specific learning themes for clinical education.

  5. Building a Multi-centre Clinical Research Facilitation Network: The ARC Experience

    Directory of Open Access Journals (Sweden)

    Ian Nicholson

    2017-06-01

    Full Text Available Introduction: In order to practice evidence-based veterinary medicine, good quality clinical evidence needs to be produced, in order that it can be apprasied systematically by the EBVM network, and used by vets. There is very little good-quality veterinary evidence for most of the veterinary procedures carried out every day across the world. Very few, if any, individuals have all the necessary qualities (case-load, time, research expertise, financial support to be able to systematically produce good-quality, and relevant, clinical research on their own, in a timely manner. The Association for Veterinary Soft Tissue Surgery (AVSTS www.avsts.org.uk is an affiliate group with the British Small Animal Veterinary Association (BSAVA, and functions as a clinical network of like-minded individuals. In 2013 AVSTS sought to create a role for itself in facilitating the production (by its members of multi-centre clinical research of relevance to its members.Materials and methods: Members of AVSTS were asked to join the AVSTS Research Cooperative (ARC, with a veterinary epidemiologist and an experienced multi-centre veterinary clinical researcher (to help with study design and statistical planning, and the Animal Health Trust clinical research ethics committee. An email list was established, and a page was set up on the AVSTS website, to allow information to be disseminated. The AVSTS spring and autumn meetings were used as a regular forum by ARC, to discuss its direction, to generate interest, to create and promote specific studies (in order to widen participation amongst different centres, and to update members about previous studies.Results: Membership of ARC has grown to 224 people, although the epidemiologist left. One multi-centre study has been published, two have been presented and await publication, one has been accepted for presentation, two other studies are gathering data at present, and further studies are in the pipeline. There has been

  6. Qualitative Research in Palliative Care: Applications to Clinical Trials Work.

    Science.gov (United States)

    Lim, Christopher T; Tadmor, Avia; Fujisawa, Daisuke; MacDonald, James J; Gallagher, Emily R; Eusebio, Justin; Jackson, Vicki A; Temel, Jennifer S; Greer, Joseph A; Hagan, Teresa; Park, Elyse R

    2017-08-01

    While vast opportunities for using qualitative methods exist within palliative care research, few studies provide practical advice for researchers and clinicians as a roadmap to identify and utilize such opportunities. To provide palliative care clinicians and researchers descriptions of qualitative methodology applied to innovative research questions relative to palliative care research and define basic concepts in qualitative research. Body: We describe three qualitative projects as exemplars to describe major concepts in qualitative analysis of early palliative care: (1) a descriptive analysis of clinician documentation in the electronic health record, (2) a thematic content analysis of palliative care clinician focus groups, and (3) a framework analysis of audio-recorded encounters between patients and clinicians as part of a clinical trial. This study provides a foundation for undertaking qualitative research within palliative care and serves as a framework for use by other palliative care researchers interested in qualitative methodologies.

  7. Clinical research ethics in Irish healthcare: diversity, dynamism and medicalization.

    LENUS (Irish Health Repository)

    Condell, Sarah L

    2012-11-01

    Gaining ethical clearance to conduct a study is an important aspect of all research involving humans but can be time-consuming and daunting for novice researchers. This article stems from a larger ethnographic study that examined research capacity building in Irish nursing and midwifery. Data were collected over a 28-month time frame from a purposive sample of 16 nurse or midwife research fellows who were funded to undertake full-time PhDs. Gaining ethical clearance for their studies was reported as an early \\'rite of passage\\' in the category of \\'labouring the doctorate\\'. This article penetrates the complexities in Irish clinical research ethics by describing the practices these nurse and midwife researchers encountered and the experiences they had. The key issue of representation that occurred in the context of \\'medicalized\\' research ethics is further explored including its meaning for nursing or midwifery research.

  8. Clinical nursing and midwifery research: grey literature in African countries.

    Science.gov (United States)

    Sun, C; Dohrn, J; Omoni, G; Malata, A; Klopper, H; Larson, E

    2016-03-01

    This study reviewed grey literature to assess clinical nursing and midwifery research conducted in southern and eastern African countries over the past decade. The shortage of published nursing research from African countries severely limits the ability of practicing nurses and midwives to base clinical decisions on solid evidence. However, little is known regarding unpublished or unindexed clinical research ('grey literature'), a potentially rich source of information. Identifying these sources may reveal resources to assist nurses in providing evidence-based care. This scoping review of grey literature on clinical nursing and midwifery research in southern and eastern African countries helped to identify gaps in research and assess whether these gaps differ from published research. Systematic searches of grey literature were performed. Research was included if it was conducted by nurses in 1 of 25 southern or eastern African countries, between 2004 and 2014 and included patient outcomes. Data were extracted on location, institution, research topic, institutional connections and author information. Chi-square tests were performed to compare differences between indexed and non-indexed literature. We found 262 studies by 287 authors from 17 southern and eastern African countries covering 13 topics. Although all topics were also found in indexed literature and there were statistically significant differences between the number of times, fewer topics were covered in grey literature vs. indexed. Patient satisfaction and experience and traditional health practices were more likely to be published, whereas chronic disease, assault and paediatric-related research were less often published. Generally, there is a paucity of clinical nursing research in this region. This could reflect the shortage of nurses prepared to conduct research in this region. Nurses may find additional resources for evidence in the grey literature. A complete understanding of the state of nursing

  9. Research Capacity at Traditional Chinese Medicine (TCM) Centers in China: A Survey of Clinical Investigators.

    Science.gov (United States)

    Feng, Shuo; Han, Mei; Lai, Lily; Wang, Si-Cheng; Liu, Jian-Ping

    2017-01-01

    Background. The development of an evidence-based approach to traditional Chinese medicine (TCM), which depends on the generation of good quality evidence, requires an adequate workforce. However, the research capacity of TCM investigators is not known. Study Design. This cross-sectional study was conducted to describe the research capacity of TCM clinical investigators in China. Participants. A total of 584 participants from TCM hospitals and research centers were included. They were asked about the academic and research characteristics, needs for research capacity building, and barriers to clinical research. Results. The majority (80.82%) were qualified to at least a Master's degree, whilst a smaller proportion (40.24%) held a senior professional title. We found that academic outputs were low with the majority (62.16%) authoring less than five publications in total. The most pressing needs for building research capacity identified were training in research methodology (97.43%) and identification of research questions (86.81%), whilst the highest ranking barriers to conducting research were limited motivation, funding (40.72%), and time (37.15%). Conclusion. The methodology training, along with investment in the research workforce, needs to be urgently addressed to improve investigators' research capacity and the development of an evidence-based approach of TCM.

  10. Research Capacity at Traditional Chinese Medicine (TCM Centers in China: A Survey of Clinical Investigators

    Directory of Open Access Journals (Sweden)

    Shuo Feng

    2017-01-01

    Full Text Available Background. The development of an evidence-based approach to traditional Chinese medicine (TCM, which depends on the generation of good quality evidence, requires an adequate workforce. However, the research capacity of TCM investigators is not known. Study Design. This cross-sectional study was conducted to describe the research capacity of TCM clinical investigators in China. Participants. A total of 584 participants from TCM hospitals and research centers were included. They were asked about the academic and research characteristics, needs for research capacity building, and barriers to clinical research. Results. The majority (80.82% were qualified to at least a Master’s degree, whilst a smaller proportion (40.24% held a senior professional title. We found that academic outputs were low with the majority (62.16% authoring less than five publications in total. The most pressing needs for building research capacity identified were training in research methodology (97.43% and identification of research questions (86.81%, whilst the highest ranking barriers to conducting research were limited motivation, funding (40.72%, and time (37.15%. Conclusion. The methodology training, along with investment in the research workforce, needs to be urgently addressed to improve investigators’ research capacity and the development of an evidence-based approach of TCM.

  11. Characteristics desired in clinical data warehouse for biomedical research.

    Science.gov (United States)

    Shin, Soo-Yong; Kim, Woo Sung; Lee, Jae-Ho

    2014-04-01

    Due to the unique characteristics of clinical data, clinical data warehouses (CDWs) have not been successful so far. Specifically, the use of CDWs for biomedical research has been relatively unsuccessful thus far. The characteristics necessary for the successful implementation and operation of a CDW for biomedical research have not clearly defined yet. THREE EXAMPLES OF CDWS WERE REVIEWED: a multipurpose CDW in a hospital, a CDW for independent multi-institutional research, and a CDW for research use in an institution. After reviewing the three CDW examples, we propose some key characteristics needed in a CDW for biomedical research. A CDW for research should include an honest broker system and an Institutional Review Board approval interface to comply with governmental regulations. It should also include a simple query interface, an anonymized data review tool, and a data extraction tool. Also, it should be a biomedical research platform for data repository use as well as data analysis. The proposed characteristics desired in a CDW may have limited transfer value to organizations in other countries. However, these analysis results are still valid in Korea, and we have developed clinical research data warehouse based on these desiderata.

  12. The Ethics of Clinical Trials Research in Severe Mood Disorders.

    Science.gov (United States)

    Nugent, Allison C; Miller, Franklin G; Henter, Ioline D; Zarate, Carlos A

    2017-07-01

    Mood disorders, including major depressive disorder (MDD) and bipolar disorder (BD), are highly prevalent, frequently disabling, and sometimes deadly. Additional research and more effective medications are desperately needed, but clinical trials research in mood disorders is fraught with ethical issues. Although many authors have discussed these issues, most do so from a theoretical viewpoint. This manuscript uses available empirical data to inform a discussion of the primary ethical issues raised in mood disorders research. These include issues of consent and decision-making capacity, including patients' motivations for participating in research. We also address drug withdrawals, placebo controls, and the overall safety of research. Finally, we examine the extant literature for studies discussing potential indirect benefits of clinical trials research to participants. Taken together, the evidence suggests that clinical trials research incorporating drug withdrawals and placebo controls can be conducted safely and ethically, even in patients with severe or treatment-resistant mood disorders. In fact, given the dearth of effective treatment options for this population, it is our opinion that a moral imperative exists to extend the offer of research participation to severely ill or treatment-resistant groups. Published 2017. This article is a U.S. Government work and is in the public domain in the USA.

  13. More ethical and more efficient clinical research: multiplex trial design.

    Science.gov (United States)

    Keus, Frederik; van der Horst, Iwan C C; Nijsten, Maarten W

    2014-08-14

    Today's clinical research faces challenges such as a lack of clinical equipoise between treatment arms, reluctance in randomizing for multiple treatments simultaneously, inability to address interactions and increasingly restricted resources. Furthermore, many trials are biased by extensive exclusion criteria, relatively small sample size and less appropriate outcome measures. We propose a 'Multiplex' trial design that preserves clinical equipoise with a continuous and factorial trial design that will also result in more efficient use of resources. This multiplex design accommodates subtrials with appropriate choice of treatment arms within each subtrial. Clinical equipoise should increase consent rates while the factorial design is the best way to identify interactions. The multiplex design may evolve naturally from today's research limitations and challenges, while principal objections seem absent. However this new design poses important infrastructural, organisational and psychological challenges that need in depth consideration.

  14. Radioactive isotopes in clinical medicine and research. Abstracts

    International Nuclear Information System (INIS)

    2005-01-01

    The contribution displays 44 abstracts and 35 posters from the 27th International Symposium on ''radioactive isotopes in clinical medicine and research'', organized by the Austrian society of nuclear medicine and the department of nuclear medicine and the center for biomedical engineering and physics of the Vienna medical university. The abstracts are sorted according to lecture headers: radiopharmaceutical sciences, endocrinology, clinical PET, neurology, oncology, physics and instrumentation, cardiology, inflammation, therapy and varia. (uke)

  15. [Conflicts of interests in clinical research in primary health care].

    Science.gov (United States)

    González-de Paz, L; Navarro-Rubio, M D; Sisó-Almirall, A

    2014-03-01

    Conflicts of interests between professionals and patients in biomedical research, is an ethical problem. None of the laws in Spain mention whether the clinical researcher has to clarify to participants the reasons why it proposes them to participate in a clinical trial. In this article, conflicts of interests in research are discussed in the context of primary healthcare. In this area conflicts of interests might alter the confidence between patients and healthcare professionals. Finally, we suggest some practical strategies that can help participants make the decision to participate in a clinical trial more willingly and freely. Copyright © 2013 Sociedad Española de Médicos de Atención Primaria (SEMERGEN). Publicado por Elsevier España. All rights reserved.

  16. Common data elements for spinal cord injury clinical research

    DEFF Research Database (Denmark)

    Biering-Sørensen, F; Alai, S; Anderson, K.

    2015-01-01

    Institutes of Health. SETTING: International Working Groups. METHODS: Nine working groups composed of international experts reviewed existing CDEs and instruments, created new elements when needed and provided recommendations for SCI clinical research. The project was carried out in collaboration...... of CDEs can facilitate SCI clinical research and trial design, data sharing and retrospective analyses. Continued international collaboration will enable consistent data collection and reporting, and will help ensure that the data elements are updated, reviewed and broadcast as additional evidence......OBJECTIVES: To develop a comprehensive set of common data elements (CDEs), data definitions, case report forms and guidelines for use in spinal cord injury (SCI) clinical research, as part of the CDE project at the National Institute of Neurological Disorders and Stroke (NINDS) of the US National...

  17. Artificial Sight Basic Research, Biomedical Engineering, and Clinical Advances

    CERN Document Server

    Humayun, Mark S; Chader, Gerald; Greenbaum, Elias

    2008-01-01

    Artificial sight is a frontier area of modern ophthalmology combining the multidisciplinary skills of surgical ophthalmology, biomedical engineering, biological physics, and psychophysical testing. Many scientific, engineering, and surgical challenges must be surmounted before widespread practical applications can be realized. The goal of Artificial Sight is to summarize the state-of-the-art research in this exciting area, and to describe some of the current approaches and initiatives that may help patients in a clinical setting. The Editors are active researchers in the fields of artificial sight, biomedical engineering and biological physics. They have received numerous professional awards and recognition for their work. The artificial sight team at the Doheny Eye Institute, led by Dr. Mark Humayun, is a world leader in this area of biomedical engineering and clinical research. Key Features Introduces and assesses the state of the art for a broad audience of biomedical engineers, biophysicists, and clinical...

  18. Evolution of Clinical Proteomics and its Role in Medicine | Office of Cancer Clinical Proteomics Research

    Science.gov (United States)

    NCI's Office of Cancer Clinical Proteomics Research authored a review of the current state of clinical proteomics in the peer-reviewed Journal of Proteome Research. The review highlights outcomes from the CPTC program and also provides a thorough overview of the different technologies that have pushed the field forward. Additionally, the review provides a vision for moving the field forward through linking advances in genomic and proteomic analysis to develop new, molecularly targeted interventions.

  19. Platelet Immunology in China: Research and Clinical Applications.

    Science.gov (United States)

    Wu, Guoguang; Zhou, Yan; Li, Lilan; Zhong, Zhoulin; Li, Hengchong; Li, Haiyan; Yu, Mei; Shen, Weidong; Ni, Heyu

    2017-04-01

    Immunization against human platelet alloantigens (HPAs) is associated with a number of clinical complications. The detection and identification of clinically relevant platelet antibodies are important for the diagnosis and management of patients affected with immune-mediated thrombocytopenias. Human platelet alloantigen frequencies and the characteristics of antiplatelet antibodies vary widely between ethnic groups. Since 2008, the importance of platelet immunology in the field of transfusion medicine has gained greater recognition by clinical laboratories in China. Laboratories in China have established and improved methods for platelet antibody detection and HPA genotyping techniques, which are used for the diagnosis of alloimmune platelet disorders in clinic and research environments. Research has revealed the frequencies of HPA alleles in different Chinese ethnic groups and compared the differences in HPA gene frequencies between the Chinese Han and other ethnic groups of the world. Production of anti-CD36 isoantibodies is an important risk factor for immune-mediated thrombocytopenia in the Chinese population. Advances in research and clinical application of platelet immunology have significantly improved the clinical diagnosis, treatment including transfusion support, and prevention of alloimmune platelet disorders in the Chinese population. Copyright © 2017. Published by Elsevier Inc.

  20. Basic and clinical research advances in ischemic stroke

    Directory of Open Access Journals (Sweden)

    Yuan-yuan MA

    2018-01-01

    Full Text Available Stroke is the most common cerebrovascular disease worldwide, which seriously affects life quality of survivals and results in huge economic burden of families and society. In terms of clinical treatment for ischemic stroke, apart from thrombolytic therapy with recombinant tissue-type plasminogen activator (rt-PA, the occurrence and successful application of endovascular thrombectomy in patients of ischemic stroke is a major breakthrough. Meanwhile, many novel clinical drugs for ischemic stroke therapy have entered into clinical trials. Most of basic and clinical researches have showed promising results in ischemic stroke therapy. This review mainly summarizes the progress of research during the period of Twelfth Five-Year Plan for National Economic and Social Development on treatment of ischemic stroke, including omics technologies, gene therapy, microRNA (miRNA interference and stem cell therapy. Stem cell therapy has shown great potential since many clinical trials have been completed or are ongoing. The development and mutual transformation of basic and clinical research will provide valuable and comprehensive information for the precise treatment of ischemic stroke.

  1. India's growing clinical research sector: opportunity for global companies.

    Science.gov (United States)

    Varawalla, Nermeen

    2007-06-01

    Backed by a compelling foundation of essential requirements necessary for effective clinical trial conduct, and aided by initiatives that address concerns of data quality, regulatory timelines and IP protection, the clinical development sector in India has experienced annual revenue growth rates of 25% in the past two to three years, and is poised to participate substantially in global drug development. As both clinical trial sponsors and CROs increase their research capabilities in India, the clinical development sector is facing challenges with staff resourcing and facilities. Existing initiatives in the clinical sector must continue, and further investment must be made by stakeholders to overcome the current limitations in sector growth. Furthermore, global organizations seeking to derive long-term sustainable revenue growth and competitive advantage in the global marketplace from their business units in India must establish an appropriate organizational culture and an effective intra-organizational and industry interface for their operations.

  2. Semantic processing of EHR data for clinical research.

    Science.gov (United States)

    Sun, Hong; Depraetere, Kristof; De Roo, Jos; Mels, Giovanni; De Vloed, Boris; Twagirumukiza, Marc; Colaert, Dirk

    2015-12-01

    There is a growing need to semantically process and integrate clinical data from different sources for clinical research. This paper presents an approach to integrate EHRs from heterogeneous resources and generate integrated data in different data formats or semantics to support various clinical research applications. The proposed approach builds semantic data virtualization layers on top of data sources, which generate data in the requested semantics or formats on demand. This approach avoids upfront dumping to and synchronizing of the data with various representations. Data from different EHR systems are first mapped to RDF data with source semantics, and then converted to representations with harmonized domain semantics where domain ontologies and terminologies are used to improve reusability. It is also possible to further convert data to application semantics and store the converted results in clinical research databases, e.g. i2b2, OMOP, to support different clinical research settings. Semantic conversions between different representations are explicitly expressed using N3 rules and executed by an N3 Reasoner (EYE), which can also generate proofs of the conversion processes. The solution presented in this paper has been applied to real-world applications that process large scale EHR data. Copyright © 2015 Elsevier Inc. All rights reserved.

  3. Bioethical Issues in Conducting Pediatric Dentistry Clinical Research.

    Science.gov (United States)

    Garrocho-Rangel, Arturo; Cerda-Cristerna, Bernardino; Pozos-Guillen, Amaury

    Pediatric clinical research on new drugs and biomaterials involves children in order to create valid and generalizable knowledge. Research on vulnerable populations, such as children, is necessary but only admissible when researchers strictly follow methodological and ethical standards, together with the respect to human rights; and very especially when the investigation cannot be conducted with other population or when the potential benefits are specifically for that age group. Clinical research in Pediatric Dentistry is not an exception. The aim of the present article was to provide the bioethical principles (with respect to the child/parents' autonomy, benefit/risk analysis, and distributive justice), and recommendations, including informed consent, research ethics committees, conflict of interest, and the "equipoise" concept. Current and future worldwide oral health research in children and adolescents must be conducted incorporating their perspectives in the decision-making process as completely as possible. This concept must be carefully considered when a dental clinical study research is going to be planned and conducted, especially in the case of randomized controlled trials, in which children will be recruited as participants.

  4. Closing the Gap between Research Evidence and Clinical Practice: Jordanian Nurses' Perceived Barriers to Research Utilisation

    Science.gov (United States)

    Al Khalaileh, Murad; Al Qadire, Mohammad; Musa, Ahmad S.; Al-Khawaldeh, Omar A.; Al Qudah, Hani; Alhabahbeh, Atalla

    2016-01-01

    Background: The nursing profession is a combination of theory and practical skill, and nurses are required to generate and develop knowledge through implementing research into clinical practice. Considerable number of barriers could hind implementing research findings into practice. Barriers to research utilisation are not identified in the…

  5. Advance directives in dementia research: The opinions and arguments of clinical researchers − an empirical study

    NARCIS (Netherlands)

    K.R. Jongsma (Karin); S. van de Vathorst (Suzanne)

    2015-01-01

    textabstractIn order to discover an effective treatment for dementia it is necessary to include dementia patients in clinical research trials. Dementia patients face an increased risk to lose the capacity to consent to research participation, and research possibilities with incompetent participants

  6. Conducting qualitative research within Clinical Trials Units: avoiding potential pitfalls.

    Science.gov (United States)

    Cooper, Cindy; O'Cathain, Alicia; Hind, Danny; Adamson, Joy; Lawton, Julia; Baird, Wendy

    2014-07-01

    The value of using qualitative research within or alongside randomised controlled trials (RCTs) is becoming more widely accepted. Qualitative research may be conducted concurrently with pilot or full RCTs to understand the feasibility and acceptability of the interventions being tested, or to improve trial conduct. Clinical Trials Units (CTUs) in the United Kingdom (UK) manage large numbers of RCTs and, increasingly, manage the qualitative research or collaborate with qualitative researchers external to the CTU. CTUs are beginning to explicitly manage the process, for example, through the use of standard operating procedures for designing and implementing qualitative research with trials. We reviewed the experiences of two UK Clinical Research Collaboration (UKCRC) registered CTUs of conducting qualitative research concurrently with RCTs. Drawing on experiences gained from 15 studies, we identify the potential for the qualitative research to undermine the successful completion or scientific integrity of RCTs. We show that potential problems can arise from feedback of interim or final qualitative findings to members of the trial team or beyond, in particular reporting qualitative findings whilst the trial is on-going. The problems include: We make recommendations for improving the management of qualitative research within CTUs. Copyright © 2014. Published by Elsevier Inc.

  7. Creating a Research Agenda and Setting Research Priorities for Clinical Nurse Specialists.

    Science.gov (United States)

    Foster, Jan; Bautista, Cynthia; Ellstrom, Kathleen; Kalowes, Peggy; Manning, Jennifer; Pasek, Tracy Ann

    The purpose of this article is to describe the evolution and results of the process for establishing a research agenda and identification of research priorities for clinical nurse specialists, approved by the National Association of Clinical Nurse Specialists (NACNS) membership and sanctioned by the NACNS Board of Directors. Development of the research agenda and identification of the priorities were an iterative process and involved a review of the literature; input from multiple stakeholders, including individuals with expertise in conducting research serving as task force members, and NACNS members; and feedback from national board members. A research agenda, which is to provide an enduring research platform, was established and research priorities, which are to be applied in the immediate future, were identified as a result of this process. Development of a research agenda and identification of research priorities are a key method of fulfilling the mission and goals of NACNS. The process and outcomes are described in this article.

  8. WAS LUXURY LITTLE RESEARCHED? AN EXPLORATION OF STUDIES AND RESEARCH TRENDS IN THE AREA OF MARKETING OF LUXURY GOODS, BEFORE 2005

    Directory of Open Access Journals (Sweden)

    Raluca CIORNEA

    2012-01-01

    Full Text Available The first questions that all scientists address when approaching a new domain are related to how well studied is the field, who and what has studied. The answers help them establish their personal areas of interest and contribution. Thus in order to help the authors concerned with the luxury domain we decided to conduct a secondary marketing research and the main purpose was to identify the studies and the trends in research in the area of marketing of luxury goods and their degree of approach, before 2005. The present study is only a part of a complex research that approaches the entire evolution in luxury research field, but due to space limitation papers were separated in two: the evolution before 2005 and the evolution after 2005. Unique by its theme, this paper is intended to be ambitious by analysing all the luxury materials to which had access the authors The results confirmed the previous statement of some authors that luxury was little researched comparing to other domains.

  9. Colon cleansing protocol in children: research conditions vs. clinical practice.

    Science.gov (United States)

    Elitsur, Yoram; Balfaqih, Yaslam; Preston, Deborah

    2018-04-01

     Colon preparation rates are the limiting factor for a successful diagnostic colonoscopy in children. Different colon cleansing protocols have been published for use in children. Unfortunately, the applicability of those published research protocols has not been formally evaluated in routine clinical practice. We investigated the success rate of our previously published colon cleansing protocol as utilized in our clinical practice.  This was a retrospective study. In the clinical practice, the colon cleansing protocol included PEG-3350 at a dose of 2 g/kg/day plus Dulcolax (Bisacodyl, Boehringer Ingelheim, TX USA) 5 mg/day for 2 days. Adequate colon preparation was graded between 1 - 5, as previously described, and grade ≥ 4.0 was considered an adequate preparation. Patients were instructed to complete a questionnaire that included PEG-3350 dose, number of stools per day, consistency of each stool, and side effects (vomiting, abdominal pain). Clinical and endoscopic results were compared between the protocol under research conditions and routine practice.  The success rate of the colon preparation in our clinical practice was similar to the results observed under our research protocol (75 % vs. 73.6 %). Moreover, the total number of stools, stool consistency, and the intubation rate of the terminal ileum were also similar. We concluded, that in our experience, the colon cleansing protocol used under research conditions was effective and appropriate for use in routine clinical practice.  We recommend testing each new protocol under the routine conditions of clinical practice to confirm its applicability for general practitioners.

  10. Reproducibility of clinical research in critical care: a scoping review.

    Science.gov (United States)

    Niven, Daniel J; McCormick, T Jared; Straus, Sharon E; Hemmelgarn, Brenda R; Jeffs, Lianne; Barnes, Tavish R M; Stelfox, Henry T

    2018-02-21

    The ability to reproduce experiments is a defining principle of science. Reproducibility of clinical research has received relatively little scientific attention. However, it is important as it may inform clinical practice, research agendas, and the design of future studies. We used scoping review methods to examine reproducibility within a cohort of randomized trials examining clinical critical care research and published in the top general medical and critical care journals. To identify relevant clinical practices, we searched the New England Journal of Medicine, The Lancet, and JAMA for randomized trials published up to April 2016. To identify a comprehensive set of studies for these practices, included articles informed secondary searches within other high-impact medical and specialty journals. We included late-phase randomized controlled trials examining therapeutic clinical practices in adults admitted to general medical-surgical or specialty intensive care units (ICUs). Included articles were classified using a reproducibility framework. An original study was the first to evaluate a clinical practice. A reproduction attempt re-evaluated that practice in a new set of participants. Overall, 158 practices were examined in 275 included articles. A reproduction attempt was identified for 66 practices (42%, 95% CI 33-50%). Original studies reported larger effects than reproduction attempts (primary endpoint, risk difference 16.0%, 95% CI 11.6-20.5% vs. 8.4%, 95% CI 6.0-10.8%, P = 0.003). More than half of clinical practices with a reproduction attempt demonstrated effects that were inconsistent with the original study (56%, 95% CI 42-68%), among which a large number were reported to be efficacious in the original study and to lack efficacy in the reproduction attempt (34%, 95% CI 19-52%). Two practices reported to be efficacious in the original study were found to be harmful in the reproduction attempt. A minority of critical care practices with research published

  11. Clinical and Outcome Research in oncology The need for integration

    Directory of Open Access Journals (Sweden)

    Apolone Giovanni

    2003-04-01

    Full Text Available Abstract Cancer is one of the main healthcare problems in Europe. Although significant progress has recently been made, long-term survival is still disappointing for most common solid tumours. The explosion of information has strengthened the need to create and sustain coordinated interaction between technology, biology, clinical research, clinical practice and health policy. A simple process based on automatic and passive translation from bench to clinical research and eventually to the bed side is usually assumed but cannot be taken for granted. A critical role might be played by Outcome Research (OR, defined as the discipline that describes, interprets, and predicts the impact of various influences, especially interventions, on final endpoints (from survival to satisfaction with care that matter to decision makers (from patients to society at large, with special emphasis on the use of patient-reported outcomes (PRO. Recently, under pressure from several parts of society, the FDA, recognizing the need for faster drug approval, has modified existing regulations and created new rules to allow anti-cancer drugs to be approved more quickly and, in certain but quite common circumstances, single arm trials and surrogate endpoints to be used as measures of clinical benefit. In this context, the faster approval process may lead to drugs being marketed without there being a complete picture of how effective or safe they are. The FDA move to speed up drug approval, together with the use of not fully validated surrogate endpoints, give OR the unique opportunity to help understand the value of drugs that have received accelerated approval. Despite this opportunity, OR has yet to demonstrate its role in this specific setting and provide proof of the validity, reliability and added value of its primary endpoint measures when evaluated in a broader context. The implementation of lines of OR in the development and evaluation of anti-cancer drugs hinges upon

  12. Common definition for categories of clinical research: a prerequisite for a survey on regulatory requirements by the European Clinical Research Infrastructures Network (ECRIN)

    DEFF Research Database (Denmark)

    Kubiak, Christine; de Andres-Trelles, Fernando; Kuchinke, Wolfgang

    2009-01-01

    in relation to the wide spectrum of clinical research, the European Clinical Research Infrastructures Network (ECRIN) developed a multinational survey in ten European countries. However a lack of common classification framework for major categories of clinical research was identified, and therefore reaching...... with cell therapy, etc.); diagnostic studies; clinical research on nutrition; other interventional clinical research (including trials in complementary and alternative medicine, trials with collection of blood or tissue samples, physiology studies, etc.); and epidemiology studies. Our classification...

  13. Mapping to Estimate Health-State Utility from Non-Preference-Based Outcome Measures: An ISPOR Good Practices for Outcomes Research Task Force Report.

    Science.gov (United States)

    Wailoo, Allan J; Hernandez-Alava, Monica; Manca, Andrea; Mejia, Aurelio; Ray, Joshua; Crawford, Bruce; Botteman, Marc; Busschbach, Jan

    2017-01-01

    Economic evaluation conducted in terms of cost per quality-adjusted life-year (QALY) provides information that decision makers find useful in many parts of the world. Ideally, clinical studies designed to assess the effectiveness of health technologies would include outcome measures that are directly linked to health utility to calculate QALYs. Often this does not happen, and even when it does, clinical studies may be insufficient for a cost-utility assessment. Mapping can solve this problem. It uses an additional data set to estimate the relationship between outcomes measured in clinical studies and health utility. This bridges the evidence gap between available evidence on the effect of a health technology in one metric and the requirement for decision makers to express it in a different one (QALYs). In 2014, ISPOR established a Good Practices for Outcome Research Task Force for mapping studies. This task force report provides recommendations to analysts undertaking mapping studies, those that use the results in cost-utility analysis, and those that need to critically review such studies. The recommendations cover all areas of mapping practice: the selection of data sets for the mapping estimation, model selection and performance assessment, reporting standards, and the use of results including the appropriate reflection of variability and uncertainty. This report is unique because it takes an international perspective, is comprehensive in its coverage of the aspects of mapping practice, and reflects the current state of the art. Copyright © 2017 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

  14. Bulls and bears: the stock market and clinical pathology research.

    Science.gov (United States)

    Khong, T Y

    2009-09-01

    To analyse the level of funded research in clinical pathology in a recent bear and bull market to act as a predictor for future funding during the current global financial crisis. The level of funding for research published in three clinical pathology journals in 2005 and 2008 to coincide with the bear market of March 2000 to October 2002 and with the subsequent bull market to October 2007 was determined using a Medline query. Other parameters examined were the type of article, affiliation of the first author and the pathology subspecialty. Approximately 30% of publications were funded and did not differ between the 2 years studied. Original research papers were more likely to be funded than case reports or reviews. Research from university departments of pathology was more likely to be funded than from hospital pathology departments but there were more publications from hospital pathology departments. The proportion of research in the different subspecialties that was funded did not differ significantly between each other and between 2005 and 2008. Based on data from the previous bear market, which was the longest and deepest of the post 1950 era, and the subsequent bull market, which led to the all-time high in the Dow Jones Industrial Index, funding for clinical pathology research does not seem to be affected by bull or bear markets.

  15. Digital pathology in nephrology clinical trials, research, and pathology practice.

    Science.gov (United States)

    Barisoni, Laura; Hodgin, Jeffrey B

    2017-11-01

    In this review, we will discuss (i) how the recent advancements in digital technology and computational engineering are currently applied to nephropathology in the setting of clinical research, trials, and practice; (ii) the benefits of the new digital environment; (iii) how recognizing its challenges provides opportunities for transformation; and (iv) nephropathology in the upcoming era of kidney precision and predictive medicine. Recent studies highlighted how new standardized protocols facilitate the harmonization of digital pathology database infrastructure and morphologic, morphometric, and computer-aided quantitative analyses. Digital pathology enables robust protocols for clinical trials and research, with the potential to identify previously underused or unrecognized clinically useful parameters. The integration of digital pathology with molecular signatures is leading the way to establishing clinically relevant morpho-omic taxonomies of renal diseases. The introduction of digital pathology in clinical research and trials, and the progressive implementation of the modern software ecosystem, opens opportunities for the development of new predictive diagnostic paradigms and computer-aided algorithms, transforming the practice of renal disease into a modern computational science.

  16. Ethical aspect of the clinical research. Informed consent in the clinical research for heavy ion radiotherapy of cancer

    International Nuclear Information System (INIS)

    Murata, Hajime

    2003-01-01

    The research center for heavy ion therapy of cancer was decided to be built in 1984 as a part of the national 10-year anticancer campaign, and construction of Heavy Ion Medical Accelerator in Chiba (HIMAC) was completed at the National Institute of Radiological Sciences in 1993. The HIMAC is the first heavy ion accelerator for only medical use in the world, and the clinical research of cancer radiotherapy was begun in 1994 using carbon ion generated by HIMAC. The purposes of the clinical research are to evaluate the safety and usefulness of carbon ion for cancer treatment, and to establish carbon ion therapy as a new and valuable tool for cancer therapy. Therefore, to obtain exact data in ethical aspect as well as scientific aspect of the clinical research, many special committees have been organized like as the committees of protocol planning for each organ, clinical study groups for each organ, evaluating committee of clinical data, and the ethical committee. Each clinical research is performed according to the research protocol of each organ, in which study purpose, rationale, patient condition, end-point of the study, adverse reaction are described. The document of informed consent (IC) contains study purpose, patient condition, method, predicted effect and demerit, protection of privacy, etc.. IC to each patient is done precisely by the doctor, and the freely-given IC of the patient is obtained. After the IC was completed, judgement of propriety for carbon ion therapy is done by the ethical committee for IC of each patient. Since 1994 carbon ion therapy has been performed over 1300 patients with cancer in various organs, and its safety and usefulness for cancer treatment has been clarified gradually. The carbon ion therapy is thought to be a new and promising tool for cancer treatment near future. (authors)

  17. Clinical research data sharing: what an open science world means for researchers involved in evidence synthesis.

    Science.gov (United States)

    Ross, Joseph S

    2016-09-20

    The International Committee of Medical Journal Editors (ICMJE) recently announced a bold step forward to require data generated by interventional clinical trials that are published in its member journals to be responsibly shared with external investigators. The movement toward a clinical research culture that supports data sharing has important implications for the design, conduct, and reporting of systematic reviews and meta-analyses. While data sharing is likely to enhance the science of evidence synthesis, facilitating the identification and inclusion of all relevant research, it will also pose key challenges, such as requiring broader search strategies and more thorough scrutiny of identified research. Furthermore, the adoption of data sharing initiatives by the clinical research community should challenge the community of researchers involved in evidence synthesis to follow suit, including the widespread adoption of systematic review registration, results reporting, and data sharing, to promote transparency and enhance the integrity of the research process.

  18. Importance of Pharmaceutical Training and Clinical Research at Medical Facilities.

    Science.gov (United States)

    Myotoku, Michiaki

    2017-01-01

    To respond to advancements in medical techniques, and to address the separation of medical and dispensary practices, clinical professors are required to educate human resource staff to become highly-skilled pharmacists. For this purpose, it is extremely important for these professors to learn about cutting-edge practical skills and knowledge, as well as to advance their expertise. In addition, they need to conduct clinical research in cooperation with relevant facilities. As our university does not have its own hospital or pharmacy, it is important to provide training for clinical professors in clinical facilities. Such training mainly involves medical teams' in-hospital rounds and participation in conferences (nutrition support team; NST), operation of the pharmacy department, and intervention targeting improvement in the department's duties. We have conducted collaborative studies, provided research instructions, implemented studies aimed at improving the department's work (pharmacists appointed on wards at all times to ensure medical safety) as well as studies regarding team medical care (nutritional evaluation during outpatient chemotherapy), and resolved issues regarding this work (drug solution mixability in a hand-held constant infusion pump, and a safe pump-filling methods). Thus, it has become possible to keep track of the current state of a pharmacists' work within team medical care, to access information about novel drugs, to view clinical and prescription-claim data, to cooperate with other professionals (e.g., doctors and nurses), to promote pharmacists' self-awareness of their roles in cooperative medical practice, and to effectively maintain the hospital's clinical settings.

  19. Clinical scientific research with ionizing radiations in Italy. Jurisprudential aspects

    International Nuclear Information System (INIS)

    Valle, G.; Frusciante, V.; Petrucelli, L.; Podagrosi, V.; Giustini, A.

    1999-01-01

    The paper reviews the laws that regulate the clinical scientific research with ionizing radiations in Italy and the effects of ICRP 62, introduced in Italy by the Minister's Decree 21/11/1997, renders invalid all previous rules and regulations which contrast with them [it

  20. Surrogate end points in clinical research: hazardous to your health.

    Science.gov (United States)

    Grimes, David A; Schulz, Kenneth F

    2005-05-01

    Surrogate end points in clinical research pose real danger. A surrogate end point is an outcome measure, commonly a laboratory test, that substitutes for a clinical event of true importance. Resistance to activated protein C, for example, has been used as a surrogate for venous thrombosis in women using oral contraceptives. Other examples of inappropriate surrogate end points in contraception include the postcoital test instead of pregnancy to evaluate new spermicides, breakage and slippage instead of pregnancy to evaluate condoms, and bone mineral density instead of fracture to assess the safety of depo-medroxyprogesterone acetate. None of these markers captures the effect of the treatment on the true outcome. A valid surrogate end point must both correlate with and accurately predict the outcome of interest. Although many surrogate markers correlate with an outcome, few have been shown to capture the effect of a treatment (for example, oral contraceptives) on the outcome (venous thrombosis). As a result, thousands of useless and misleading reports on surrogate end points litter the medical literature. New drugs have been shown to benefit a surrogate marker, but, paradoxically, triple the risk of death. Thousands of patients have died needlessly because of reliance on invalid surrogate markers. Researchers should avoid surrogate end points unless they have been validated; that requires at least one well done trial using both the surrogate and true outcome. The clinical maxim that "a difference to be a difference must make a difference" applies to research as well. Clinical research should focus on outcomes that matter.

  1. Fair Inclusion of Pregnant Women in Clinical Research

    NARCIS (Netherlands)

    van der Zande, I.S.E.

    2017-01-01

    Background: There has always been a reluctance to include pregnant women in clinical research, due to a fear of harm to the foetus. At the same time, there is a need for evidence-based information on medications and treatments for pregnant women who are or become ill during their pregnancy, which

  2. Original Research Clinical characteristics and outcomes of patients ...

    African Journals Online (AJOL)

    Epidemiological data on stroke in Zimbabwe are scarce and few clinical studies have been performed to date. ... Original Research ... of the patients were in the economically active group with ..... in Sub-Saharan Africa: what we know now; International Journal of ... University of Medicine and Dentistry OF New Jersey.

  3. Core outcome sets for research and clinical practice

    NARCIS (Netherlands)

    Chiarotto, Alessandro; Ostelo, Raymond W.; Turk, Dennis C.; Buchbinder, Rachelle; Boers, Maarten

    2017-01-01

    Background This masterclass introduces the topic of core outcome sets, describing rationale and methods for developing them, and providing some examples that are relevant for clinical research and practice. Method A core outcome set is a minimum consensus-based set of outcomes that should be

  4. A pragmatic analysis of vulnerability in clinical research.

    Science.gov (United States)

    Wendler, David

    2017-09-01

    Identifying which subjects are vulnerable, and implementing safeguards to protect them, is widely regarded as essential to clinical research. Commentators have endorsed a number of responses to these challenges and have thereby made significant progress in understanding vulnerability in clinical research. At the same time, this literature points to a central contradiction which calls into question its potential to protect vulnerable subjects in practice. Specifically, analysis suggests that all human subjects are vulnerable and vulnerability in clinical research is comparative and context dependent, in the sense that individuals are vulnerable relative to others and in some contexts only. Yet, if everyone is vulnerable, there seems to be no point in citing the vulnerability of some individuals. Moreover, the conclusion that everyone is vulnerable seems inconsistent with the claims that vulnerability is comparative and context dependent, raising concern over whether it will be possible to develop a comprehensive account of vulnerability that is internally consistent. The solution to this dilemma lies in recognition of the fact that the practical significance of claims regarding vulnerability depends on the context in which they are used. The claims that appear to lead to the central contradiction are in fact accurate conclusions that follow from different uses of the term 'vulnerability'. The present manuscript describes this 'pragmatic' approach to vulnerability in clinical research and considers its implications for ensuring that subjects receive appropriate protection. Published 2017. This article is a U.S. Government work and is in the public domain in the USA.

  5. Veracity in big data: How good is good enough.

    Science.gov (United States)

    Reimer, Andrew P; Madigan, Elizabeth A

    2018-01-01

    Veracity, one of the five V's used to describe big data, has received attention when it comes to using electronic medical record data for research purposes. In this perspective article, we discuss the idea of data veracity and associated concepts as it relates to the use of electronic medical record data and administrative data in research. We discuss the idea that electronic medical record data are "good enough" for clinical practice and, as such, are "good enough" for certain applications. We then propose three primary issues to attend to when establishing data veracity: data provenance, cross validation, and context.

  6. Data management in clinical research: Synthesizing stakeholder perspectives.

    Science.gov (United States)

    Johnson, Stephen B; Farach, Frank J; Pelphrey, Kevin; Rozenblit, Leon

    2016-04-01

    This study assesses data management needs in clinical research from the perspectives of researchers, software analysts and developers. This is a mixed-methods study that employs sublanguage analysis in an innovative manner to link the assessments. We performed content analysis using sublanguage theory on transcribed interviews conducted with researchers at four universities. A business analyst independently extracted potential software features from the transcriptions, which were translated into the sublanguage. This common sublanguage was then used to create survey questions for researchers, analysts and developers about the desirability and difficulty of features. Results were synthesized using the common sublanguage to compare stakeholder perceptions with the original content analysis. Individual researchers exhibited significant diversity of perspectives that did not correlate by role or site. Researchers had mixed feelings about their technologies, and sought improvements in integration, interoperability and interaction as well as engaging with study participants. Researchers and analysts agreed that data integration has higher desirability and mobile technology has lower desirability but disagreed on the desirability of data validation rules. Developers agreed that data integration and validation are the most difficult to implement. Researchers perceive tasks related to study execution, analysis and quality control as highly strategic, in contrast with tactical tasks related to data manipulation. Researchers have only partial technologic support for analysis and quality control, and poor support for study execution. Software for data integration and validation appears critical to support clinical research, but may be expensive to implement. Features to support study workflow, collaboration and engagement have been underappreciated, but may prove to be easy successes. Software developers should consider the strategic goals of researchers with regard to the

  7. Knowledge, compliance with good clinical practices and barriers to effective control of postoperative pain among nurses from hospitals with and without a "Hospital without Pain" certificate.

    Science.gov (United States)

    Tomaszek, Lucyna; Dębska, Grażyna

    2018-04-01

    (i) To compare knowledge and compliance with good clinical practices regarding control of postoperative pain among nurses employed at hospitals with and without a "Hospital without Pain" certificate, (ii) to identify the determinants of nurses' knowledge and (iii) to define barriers to effective control of postoperative pain. Only a slight improvement in postoperative pain control has been observed recently, if any. Implementation of good clinical practices in the control of postoperative pain requires involvement of nurses. A cross-sectional study. The study included 257 nurses from hospitals with a "Hospital without Pain" certificate and 243 nurses from noncertified hospitals, with mean job seniority of 17.6 ± 9.6 years. All respondents answered 26 questions regarding postoperative pain control-related issues. Based on the answers, overall scores were calculated for (i) nurses' knowledge, (ii) compliance with good clinical practices and (iii) barriers to effective control of postoperative pain. Nurses from the certified hospitals presented with significantly higher levels of knowledge and compliance with good clinical practices and identified significantly more barriers to effective control of postoperative pain. Apart from certification of a hospital, better knowledge of postoperative pain control was determined by higher education, participation in postgraduate training programmes and other relevant courses, self-education from medical journals, employment at paediatric ward or intensive care unit. The most commonly reported barriers to effective control of pain included too low doses of painkillers prescribed by physicians and inability to modify the protocol of pain treatment by the nurse. Control of postoperative pain can be improved by enrolling nurses in various forms of continuous training and by providing them with greater autonomy in administering painkillers to surgical patients. Better quality of care offered to patients with postoperative pain

  8. Clinical gait analysis : A review of research at the Interdepartmental Research group of Kinesiology in Leiden

    NARCIS (Netherlands)

    Daanen, H. A M

    1990-01-01

    In this article the methodology used in the Interdepartmental Research Group of Kinesiology to quantify (clinical) human gait is elaborated upon. Four methods are described: analysis of temporal parameters, goniometry, accelerometry and electromyography. A correct representation of electromyographic

  9. Research on the Impacts of Expensive Food and Luxury Goods Import Tariff Adjustment on Chinese Economy and Related Measures

    OpenAIRE

    Qishen Zhou; Mingxing Yang

    2013-01-01

    This study aims to investigate the impacts of expensive food and luxury goods import tariff adjustment on Chinese economy and related measures. Nowadays, Asia especially China has been the world’s biggest expensive food and luxury goods market. However, due to relatively higher luxury import tariff in China, most consumers have chosen to purchase expensive food and luxury goods abroad which leads to a large of domestic consumption cash outflow. Therefore, whether to cut the luxury import tari...

  10. [Collections of human biological resources for research purposes: from regulations to the need of a guide of good collection practices].

    Science.gov (United States)

    Le Roux, N; de Montgolfier, S; di Donato, J-H; Boccon-Gibod, L; Teillac, P; Hervé, C; Berthon, P

    2003-12-01

    In France, collections of human biological resources are regulated by the "Bioethics Law", currently in revision. Hence, we analyse the regulatory and ethical issues of these practices in the context of scientific research. The ultimate aim of such collections is to improve biological and medical knowledge. We think that the French regulatory system is quite complicated and non-explicit for "collection holders". The multiplicity of legal texts concerning this activity has made their application difficult, especially in the absence of application decrees. The project amending the actual law has clarified the legal status of collections but it did not shed light on the status of human body detached parts. Furthermore, the text is still very far from the international bioethical recommendations, and does not reflect the actual collection's implementation. The establishment of a guideline of Good Collection Practices, based on clear principles, should help to simplify the situation, especially when it is imbedded in the regulation and linked to control procedures. It would allow a balance between collective interests and the protection of individuals, taking into account of the international highly competitive scientific and economical constraints. The major issue is to preserve and to perpetuate the existing and future collections because of their precious value as an important tool for biomedical knowledge. The efficiency of a regulation depends on its legibility and accessibility, two requirements that seem to determine the acceptance of the regulatory tool and its application allowing subsequently to reach fairness in proceedings.

  11. The good and bad of group conformity: a call for a new programme of research in medical education.

    Science.gov (United States)

    Beran, Tanya N; Kaba, Alyshah; Caird, Jeff; McLaughlin, Kevin

    2014-09-01

    Given that a significant portion of medical education occurs in various social settings (small groups, large classes, clinical environments), it is critical to examine how group members interact. One type of influence on these interactions is conformity, whereby an individual changes his or her own behaviour to match incorrect responses of others in a group. Conformity to peer pressure has been replicated in experimental research conducted in many countries over the last 60 years. There is newly emerging empirical evidence of this effect in medical education, suggesting that subtle motivations and pressures within a group may prevent students from challenging or questioning information that seems incorrect. This narrative review aims to present an overview of theory and findings in research into conformity in the fields of social psychology, business, sociology and aviation theory to demonstrate its direct relevance to medical education and the health professions. We searched online databases (MEDLINE, PubMed, PsycINFO and ProQuest) from the University of Calgary catalogue. We also searched citations in articles reviewed and references provided by colleagues. We limited our narrative review to publications released between 1950 and 2012. Group conformity behaviour may be one of a number of communication challenges associated with interprofessional care, and may represent a factor contributing to the burden of adverse events. This paper calls for a new programme of research into conformity in medical education that provides systematic empirical evidence of its relevance and applications in education, health care and practice. This review reveals decades of anecdotal and empirical evidence that conformity is a pervasive phenomenon across disciplines. Further research is needed to elucidate which situations pose the greatest risk for the occurrence of conformity, how to manage it in practice and its implications for patient safety. © 2014 John Wiley & Sons Ltd.

  12. The UK clinical research network - has it been a success for dermatology clinical trials?

    Directory of Open Access Journals (Sweden)

    Charlesworth Lisa

    2011-06-01

    Full Text Available Abstract Background Following the successful introduction of five topic-specific research networks in the UK, the Comprehensive Local Research Network (CLRN was established in 2008 in order to provide a blanket level of support across the whole country regardless of the clinical discipline. The role of the CLRN was to facilitate recruitment into clinical trials, and to encourage greater engagement in research throughout the National Health Service (NHS. Methods This report evaluates the impact of clinical research networks in supporting clinical trials in the UK, with particular reference to our experiences from two non-commercial dermatology trials. It covers our experience of engaging with the CLRN (and other research networks using two non-commercial dermatology trials as case studies. We present the circumstances that led to our approach to the research networks for support, and the impact that this support had on the delivery of these trials. Results In both cases, recruitment was boosted considerably following the provision of additional support, although other factors such as the availability of experienced personnel, and the role of advertising and media coverage in promoting the trials were also important in translating this additional resource into increased recruitment. Conclusions Recruitment into clinical trials is a complex task that can be influenced by many factors. A world-class clinical research infrastructure is now in place in England (with similar support available in Scotland and Wales, and it is the responsibility of the research community to ensure that this unique resource is used effectively and responsibly.

  13. Clinical Application of Neuroplastic Brain Research in Eating Disorder Treatment

    Directory of Open Access Journals (Sweden)

    Abigail H. Natenshon

    2016-12-01

    Neurophysiological and psychophysiological treatment interventions, by carving new neuronal pathways and creating connectivity that augments brain circuitry, carry the potential to remediate body image and self-image distortions, reintegrating the fragmented eating disordered core self. To date, intentional partnering between therapist, ED patient, and neuroplastic brain has been rarely applied in the clinical milieu and minimally referenced in the treatment literature. By bringing current neuroplasticity research into frontline practice, ED practitioners not only bridge the research/practice gap, but redefine new directions for future ED research.

  14. Encouraging primary care research: evaluation of a one-year, doctoral clinical epidemiology research course.

    Science.gov (United States)

    Liira, Helena; Koskela, Tuomas; Thulesius, Hans; Pitkälä, Kaisu

    2016-01-01

    Research and PhDs are relatively rare in family medicine and primary care. To promote research, regular one-year research courses for primary care professionals with a focus on clinical epidemiology were started. This study explores the academic outcomes of the first four cohorts of research courses and surveys the participants' perspectives on the research course. An electronic survey was sent to the research course participants. All peer-reviewed scientific papers published by these students were retrieved by literature searches in PubMed. Primary care in Finland. A total of 46 research course participants who had finished the research courses between 2007 and 2012. Of the 46 participants 29 were physicians, eight nurses, three dentists, four physiotherapists, and two nutritionists. By the end of 2014, 28 of the 46 participants (61%) had published 79 papers indexed in PubMed and seven students (15%) had completed a PhD. The participants stated that the course taught them critical thinking, and provided basic research knowledge, inspiration, and fruitful networks for research. A one-year, multi-professional, clinical epidemiology based research course appeared to be successful in encouraging primary care research as measured by research publications and networking. Activating teaching methods, encouraging focus on own research planning, and support from peers and tutors helped the participants to embark on research projects that resulted in PhDs for 15% of the participants. Clinical research and PhDs are rare in primary care in Finland, which has consequences for the development of the discipline and for the availability of clinical lecturers at the universities. A clinical epidemiology oriented, one-year research course increased the activity in primary care research. Focus on own research planning and learning the challenges of research with peers appeared to enhance the success of a doctoral research course. A doctoral research course encouraged networking, and

  15. Regulatory Framework for Conducting Clinical Research in Canada.

    Science.gov (United States)

    Alas, Josmar K; Godlovitch, Glenys; Mohan, Connie M; Jelinski, Shelly A; Khan, Aneal A

    2017-09-01

    Research in human subjects is at the core of achieving improvements in health outcomes. For clinical trials, in addition to the peer review of the results before publication, it is equally important to consider whether the trial will be conducted in a manner that generates data of the highest quality and provides a measure of safety for the participating subjects. In Canada, there is no definitive legislation that governs the conduct of research involving human subjects, but a network of regulations at different levels does provide a framework for both principal investigators and sponsors. In this paper, we provide an overview of the federal, provincial and institutional legislation, guidelines and policies that will inform readers about the requirements for clinical trial research. This includes a review of the role of the Food and Drug Regulations under the Food and Drugs Act and the Tri-Council Policy Statement (TCPS2), an overview of provincial legislation across the country, and a focus on selected policies from institutional research ethics boards and public health agencies. Many researchers may find navigation through regulations frustrating, and there is a paucity of information that explains the interrelationship between the different regulatory agencies in Canada. Better understanding the process, we feel, will facilitate investigators interested in clinical trials and also enhance the long-term health of Canadians.

  16. Bibliography of clinical research in malaysia: methods and brief results.

    Science.gov (United States)

    Teng, C L; Zuhanariah, M N; Ng, C S; Goh, C C

    2014-08-01

    This article describes the methodology of this bibliography. A search was conducted on the following: (1) bibliographic databases (PubMed, Scopus, and other databases) using search terms that maximize the retrieval of Malaysian publications; (2) Individual journal search of Malaysian healthrelated journals; (3) A targeted search of Google and Google Scholar; (4) Searching of Malaysian institutional repositories; (5) Searching of Ministry of Health and Clinical Research Centre website. The publication years were limited to 2000- 2013. The citations were imported or manually entered into bibliographic software Refworks. After removing duplicates, and correcting data entry errors, PubMed's Medical Subject Headings (MeSH terms) were added. Clinical research is coded using the definition "patient-oriented-research or research conducted with human subjects (or on material of human origin) for which the investigator directly interacts with the human subjects at some point during the study." A bibliography of citations [n=2056] that fit the criteria of clinical research in Malaysia in selected topics within five domains was generated: Cancers [589], Cardiovascular diseases [432], Infections [795], Injuries [142], and Mental Health [582]. This is done by retrieving citations with the appropriate MESH terms, as follow: For cancers (Breast Neoplasms; Colorectal Neoplasms; Uterine Cervical Neoplasms), for cardiovascular diseases (Coronary Disease; Hypertension; Stroke), for infections (Dengue; Enterovirus Infections, HIV Infections; Malaria; Nipah Virus; Tuberculosis), for injuries (Accidents, Occupational; Accidents, Traffic; Child Abuse; Occupational Injuries), for mental health (Depression; Depressive Disorder; Depressive Disorder, Major; Drug Users; Psychotic Disorders; Suicide; Suicide, Attempted; Suicidal Ideation; Substance- Related Disorders).

  17. The Ethics of Clinical Care and the Ethics of Clinical Research: Yin and Yang.

    Science.gov (United States)

    Kowalski, Charles J; Hutchinson, Raymond J; Mrdjenovich, Adam J

    2017-02-01

    The Belmont Report's distinction between research and the practice of accepted therapy has led various authors to suggest that these purportedly distinct activities should be governed by different ethical principles. We consider some of the ethical consequences of attempts to separate the two and conclude that separation fails along ontological, ethical, and epistemological dimensions. Clinical practice and clinical research, as with yin and yang, can be thought of as complementary forces interacting to form a dynamic system in which the whole exceeds the sum of its parts. Just as effective clinical practice cannot exist without clinical research, meaningful clinical research requires the context of clinical practice. We defend this thesis by triangulation, that is, by outlining how multiple investigators have reached this conclusion on the basis of varied theoretical and applied approaches. More confidence can be placed in a result if different methods/viewpoints have led to that result. © The Author 2017. Published by Oxford University Press, on behalf of the Journal of Medicine and Philosophy Inc. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

  18. Understanding clinical reasoning in osteopathy: a qualitative research approach.

    Science.gov (United States)

    Grace, Sandra; Orrock, Paul; Vaughan, Brett; Blaich, Raymond; Coutts, Rosanne

    2016-01-01

    Clinical reasoning has been described as a process that draws heavily on the knowledge, skills and attributes that are particular to each health profession. However, the clinical reasoning processes of practitioners of different disciplines demonstrate many similarities, including hypothesis generation and reflective practice. The aim of this study was to understand clinical reasoning in osteopathy from the perspective of osteopathic clinical educators and the extent to which it was similar or different from clinical reasoning in other health professions. This study was informed by constructivist grounded theory. Participants were clinical educators in osteopathic teaching institutions in Australia, New Zealand and the UK. Focus groups and written critical reflections provided a rich data set. Data were analysed using constant comparison to develop inductive categories. According to participants, clinical reasoning in osteopathy is different from clinical reasoning in other health professions. Osteopaths use a two-phase approach: an initial biomedical screen for serious pathology, followed by use of osteopathic reasoning models that are based on the relationship between structure and function in the human body. Clinical reasoning in osteopathy was also described as occurring in a number of contexts (e.g. patient, practitioner and community) and drawing on a range of metaskills (e.g. hypothesis generation and reflexivity) that have been described in other health professions. The use of diagnostic reasoning models that are based on the relationship between structure and function in the human body differentiated clinical reasoning in osteopathy. These models were not used to name a medical condition but rather to guide the selection of treatment approaches. If confirmed by further research that clinical reasoning in osteopathy is distinct from clinical reasoning in other health professions, then osteopaths may have a unique perspective to bring to multidisciplinary

  19. Use of altered informed consent in pragmatic clinical research.

    Science.gov (United States)

    McKinney, Ross E; Beskow, Laura M; Ford, Daniel E; Lantos, John D; McCall, Jonathan; Patrick-Lake, Bray; Pletcher, Mark J; Rath, Brian; Schmidt, Hollie; Weinfurt, Kevin

    2015-10-01

    There are situations in which the requirement to obtain conventional written informed consent can impose significant or even insurmountable barriers to conducting pragmatic clinical research, including some comparative effectiveness studies and cluster-randomized trials. Although certain federal regulations governing research in the United States (45 CFR 46) define circumstances in which any of the required elements may be waived, the same standards apply regardless of whether any single element is to be waived or whether consent is to be waived in its entirety. Using the same threshold for a partial or complete waiver limits the options available to institutional review boards as they seek to optimize a consent process. In this article, we argue that new standards are necessary in order to enable important pragmatic clinical research while at the same time protecting patients' rights and interests. © The Author(s) 2015.

  20. Classification of Clinical Research Study Eligibility Criteria to Support Multi-Stage Cohort Identification Using Clinical Data Repositories.

    Science.gov (United States)

    Cimino, James J; Lancaster, William J; Wyatt, Mathew C

    2017-01-01

    One of the challenges to using electronic health record (EHR) repositories for research is the difficulty mapping study subject eligibility criteria to the query capabilities of the repository. We sought to characterize criteria as "easy" (searchable in a typical repository), "hard" (requiring manual review of the record data), and "impossible" (not typically available in EHR repositories). We obtained 292 criteria from 20 studies available from Clinical Trials.gov and rated them according to our three types, plus a fourth "mixed" type. We had good agreement among three independent reviewers and chose 274 criteria that were characterized by single types for further analysis. The resulting analysis showed typical features of criteria that do and don't map to repositories. We propose that these features be used to guide researchers in specifying eligibility criteria to improve development of enrollment workflow, including the definition of EHR repository queries for self-service or analyst-mediated retrievals.

  1. [Learning during the early clinical years takes more than good study habits: Perceptions of students and teachers].

    Science.gov (United States)

    Zúñiga, Denisse; Leiva, Isabel; Calderón, Maribel; Tomicic, Alemka; Padilla, Oslando; Riquelme, Arnoldo; Bitran, Marcela

    2015-11-01

    Teaching methods of the undergraduate medical curriculum change considerably from the first years to clinical training. Clinical learning occurs in complex and varied scenarios while caring for patients. Students have to adapt their learning approaches and strategies to be able to integrate theory and clinical practice and become experiential learners. To identify the strategies used by medical students to learn during the initial clinical years, as reported by students themselves and by their clinical tutors. We performed eight focus group discussions with 54 students enrolled in years three to six and we interviewed eight clinical tutors. Both focus group discussions and interviews were audio recorded, transcribed and analyzed according to Grounded Theory. Four main themes were identified in the discourse of both students and tutors: Strategies oriented to theoretical learning, strategies oriented to experiential learning, strategies for integrating theory and practice and strategies oriented to evaluation. The mentioning of individual differences was present across the reports of both students and tutors. Students use a rich variety of strategies to face the challenges of clinical learning. Both students and tutors recognize that the learning approaches and strategies vary according the nature of the task and individual differences. The responses of students bring particular knowledge of the approaches used for the theoretical and practical integration and delve into the social dimension of learning.

  2. Teaching clinical reasoning by making thinking visible: an action research project with allied health clinical educators.

    Science.gov (United States)

    Delany, Clare; Golding, Clinton

    2014-01-30

    Clinical reasoning is fundamental to all forms of professional health practice, however it is also difficult to teach and learn because it is complex, tacit, and effectively invisible for students. In this paper we present an approach for teaching clinical reasoning based on making expert thinking visible and accessible to students. Twenty-one experienced allied health clinical educators from three tertiary Australian hospitals attended up to seven action research discussion sessions, where they developed a tentative heuristic of their own clinical reasoning, trialled it with students, evaluated if it helped their students to reason clinically, and then refined it so the heuristic was targeted to developing each student's reasoning skills. Data included participants' written descriptions of the thinking routines they developed and trialed with their students and the transcribed action research discussion sessions. Content analysis was used to summarise this data and categorise themes about teaching and learning clinical reasoning. Two overriding themes emerged from participants' reports about using the 'making thinking visible approach'. The first was a specific focus by participating educators on students' understanding of the reasoning process and the second was heightened awareness of personal teaching styles and approaches to teaching clinical reasoning. We suggest that the making thinking visible approach has potential to assist educators to become more reflective about their clinical reasoning teaching and acts as a scaffold to assist them to articulate their own expert reasoning and for students to access and use.

  3. Leaders, leadership and future primary care clinical research

    Directory of Open Access Journals (Sweden)

    Qureshi Nadeem

    2008-09-01

    Full Text Available Abstract Background A strong and self confident primary care workforce can deliver the highest quality care and outcomes equitably and cost effectively. To meet the increasing demands being made of it, primary care needs its own thriving research culture and knowledge base. Methods Review of recent developments supporting primary care clinical research. Results Primary care research has benefited from a small group of passionate leaders and significant investment in recent decades in some countries. Emerging from this has been innovation in research design and focus, although less is known of the effect on research output. Conclusion Primary care research is now well placed to lead a broad re-vitalisation of academic medicine, answering questions of relevance to practitioners, patients, communities and Government. Key areas for future primary care research leaders to focus on include exposing undergraduates early to primary care research, integrating this early exposure with doctoral and postdoctoral research career support, further expanding cross disciplinary approaches, and developing useful measures of output for future primary care research investment.

  4. Fiction-reading for good or ill: eating disorders, interpretation and the case for creative bibliotherapy research.

    Science.gov (United States)

    Troscianko, Emily T

    2018-04-21

    Compared with self-help bibliotherapy, little is known about the efficacy of creative bibliotherapy or the mechanisms of its possible efficacy for eating disorders or any other mental health condition. It is clear, however, that fiction is widely used informally as a therapeutic or antitherapeutic tool and that it has considerable potential in both directions, with a possibly significant distinction between the effects of reading fiction about eating disorders (which may-contrary to theoretical predictions-be broadly negative in effect) or one's preferred genre of other fiction (which may be broadly positive). Research on creative bibliotherapy, especially systematic experimental research, is lacking and requires a medical humanities approach, drawing on knowledge and methods from psychology and cognitive literary studies as well as clinical disciplines to expand our understanding of how the dynamic processes of interpretation mediate between textual structures and characteristics of mental health and illness. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  5. Clinical research in small genomically stratified patient populations.

    Science.gov (United States)

    Martin-Liberal, J; Rodon, J

    2017-07-01

    The paradigm of early drug development in cancer is shifting from 'histology-oriented' to 'molecularly oriented' clinical trials. This change can be attributed to the vast amount of tumour biology knowledge generated by large international research initiatives such as The Cancer Genome Atlas (TCGA) and the use of next generation sequencing (NGS) techniques developed in recent years. However, targeting infrequent molecular alterations entails a series of special challenges. The optimal molecular profiling method, the lack of standardised biological thresholds, inter- and intra-tumor heterogeneity, availability of enough tumour material, correct clinical trials design, attrition rate, logistics or costs are only some of the issues that need to be taken into consideration in clinical research in small genomically stratified patient populations. This article examines the most relevant challenges inherent to clinical research in these populations. Moreover, perspectives from the Academia point of view are reviewed as well as initiatives to be taken in forthcoming years. Copyright © 2017 Elsevier Ltd. All rights reserved.

  6. Clinical research of traditional Chinese medicine in big data era.

    Science.gov (United States)

    Zhang, Junhua; Zhang, Boli

    2014-09-01

    With the advent of big data era, our thinking, technology and methodology are being transformed. Data-intensive scientific discovery based on big data, named "The Fourth Paradigm," has become a new paradigm of scientific research. Along with the development and application of the Internet information technology in the field of healthcare, individual health records, clinical data of diagnosis and treatment, and genomic data have been accumulated dramatically, which generates big data in medical field for clinical research and assessment. With the support of big data, the defects and weakness may be overcome in the methodology of the conventional clinical evaluation based on sampling. Our research target shifts from the "causality inference" to "correlativity analysis." This not only facilitates the evaluation of individualized treatment, disease prediction, prevention and prognosis, but also is suitable for the practice of preventive healthcare and symptom pattern differentiation for treatment in terms of traditional Chinese medicine (TCM), and for the post-marketing evaluation of Chinese patent medicines. To conduct clinical studies involved in big data in TCM domain, top level design is needed and should be performed orderly. The fundamental construction and innovation studies should be strengthened in the sections of data platform creation, data analysis technology and big-data professionals fostering and training.

  7. Are research papers reporting results from nutrigenetics clinical research a potential source of biohype?

    Science.gov (United States)

    Stenne, R; Hurlimann, T; Godard, Béatrice

    2012-01-01

    Nutrigenetics is a promising field, but the achievability of expected benefits is challenged by the methodological limitations that are associated with clinical research in that field. The mere existence of these limitations suggests that promises about potential outcomes may be premature. Thus, benefits claimed in scientific journal articles in which these limitations are not acknowledged might stimulate biohype. This article aims to examine whether nutrigenetics clinical research articles are a potential source of biohype. Of the 173 articles identified, 16 contained claims in which clinical applications were extrapolated from study results. The methodological limitations being incompletely acknowledged, these articles could potentially be a source of biohype.

  8. Impact of radiation research on clinical trials in radiation oncology

    International Nuclear Information System (INIS)

    Rubin, P.; Van Ess, J.D.

    1989-01-01

    The authors present an outline review of the history of the formation of the cooperative group called International Clinical Trials in Radiation Oncology (ICTRO), and the following areas are briefly discussed together with some projections for the direction of clinical trials in radiation oncology into the 1990s:- radiosensitizers, radioprotectors, and their combination, drug-radiation interactions, dose/time/fractionation, hyperthermia, biological response modifiers and radiolabelled antibodies, high LET, particularly neutron therapy, large field irradiation and interoperative irradiation, research studies on specific sites. (U.K.)

  9. Revisioning Clinical Psychology: Integrating Cultural Psychology into Clinical Research and Practice with Portuguese Immigrants

    OpenAIRE

    James, Susan; Harris, Sara; Foster, Gary; Clarke, Juanne; Gadermann, Anne; Morrison, Marie; Bezanson, Birdie Jane

    2013-01-01

    This article outlines a model for conducting psychotherapy with people of diverse cultural backgrounds. The theoretical foundation for the model is based on clinical and cultural psychology. Cultural psychology integrates psychology and anthropology in order to provide a complex understanding of both culture and the individual within his or her cultural context. The model proposed in this article is also based on our clinical experience and mixed method research with the Portuguese communi...

  10. Physician to investigator: clinical practice to clinical research--ethical, operational, and financial considerations.

    Science.gov (United States)

    Pierre, Christine

    2008-01-01

    Physicians who participate in clinical research studies gain benefits for themselves, their practice, and their patients. Historically, private practice physicians have chosen to defer to their counterparts in academic medicine when it comes to contributing to scientific advancement through clinical studies. A growing number of private practice physicians are now taking a serious second look and deciding that there are unique benefits for both the practice and the patient. Physicians who decide to participate in clinical research should give serious consideration to the time and resources that are required to meet both federal regulations and industry standards. In addition, ethical and scientific principles for assuring the protection of human research subjects must be a paramount commitment.

  11. Conducting Clinically Based Intimate Partner Violence Research: Safety Protocol Recommendations.

    Science.gov (United States)

    Anderson, Jocelyn C; Glass, Nancy E; Campbell, Jacquelyn C

    Maintaining safety is of utmost importance during research involving participants who have experienced intimate partner violence (IPV). Limited guidance on safety protocols to protect participants is available, particularly information related to technology-based approaches to informed consent, data collection, and contacting participants during the course of a study. The purpose of the article is to provide details on the safety protocol developed and utilized with women receiving care at an urban HIV clinic and who were taking part in an observational study of IPV, mental health symptoms, and substance abuse and their relationship to HIV treatment adherence. The protocol presents the technological strategies to promote safety and allow autonomy in participant decision-making throughout the research process, including Voice over Internet Protocol telephone numbers, and tablet-based eligibility screening and data collection. Protocols for management of participants at risk for suicide and/or intimate partner homicide that included automated high-risk messaging to participants and research staff and facilitated disclosure of risk to clinical staff based on participant preferences are discussed. Use of technology and partnership with clinic staff helped to provide an environment where research regarding IPV could be conducted without undue burden or risk to participants. Utilizing tablet-based survey administration provided multiple practical and safety benefits for participants. Most women who screened into high-risk categories for suicide or intimate partner homicide did not choose to have their results shared with their healthcare providers, indicating the importance of allowing participants control over information sharing whenever possible.

  12. Qualitative research within trials: developing a standard operating procedure for a clinical trials unit

    Science.gov (United States)

    2013-01-01

    Background Qualitative research methods are increasingly used within clinical trials to address broader research questions than can be addressed by quantitative methods alone. These methods enable health professionals, service users, and other stakeholders to contribute their views and experiences to evaluation of healthcare treatments, interventions, or policies, and influence the design of trials. Qualitative data often contribute information that is better able to reform policy or influence design. Methods Health services researchers, including trialists, clinicians, and qualitative researchers, worked collaboratively to develop a comprehensive portfolio of standard operating procedures (SOPs) for the West Wales Organisation for Rigorous Trials in Health (WWORTH), a clinical trials unit (CTU) at Swansea University, which has recently achieved registration with the UK Clinical Research Collaboration (UKCRC). Although the UKCRC requires a total of 25 SOPs from registered CTUs, WWORTH chose to add an additional qualitative-methods SOP (QM-SOP). Results The qualitative methods SOP (QM-SOP) defines good practice in designing and implementing qualitative components of trials, while allowing flexibility of approach and method. Its basic principles are that: qualitative researchers should be contributors from the start of trials with qualitative potential; the qualitative component should have clear aims; and the main study publication should report on the qualitative component. Conclusions We recommend that CTUs consider developing a QM-SOP to enhance the conduct of quantitative trials by adding qualitative data and analysis. We judge that this improves the value of quantitative trials, and contributes to the future development of multi-method trials. PMID:23433341

  13. Systematic collection of patient reported outcome research data: A checklist for clinical research professionals.

    Science.gov (United States)

    Wehrlen, Leslie; Krumlauf, Mike; Ness, Elizabeth; Maloof, Damiana; Bevans, Margaret

    2016-05-01

    Understanding the human experience is no longer an outcome explored strictly by social and behavioral researchers. Increasingly, biomedical researchers are also including patient reported outcomes (PROs) in their clinical research studies not only due to calls for increased patient engagement in research but also healthcare. Collecting PROs in clinical research studies offers a lens into the patient's unique perspective providing important information to industry sponsors and the FDA. Approximately 30% of trials include PROs as primary or secondary endpoints and a quarter of FDA new drug, device and biologic applications include PRO data to support labeling claims. In this paper PRO, represents any information obtained directly from the patient or their proxy, without interpretation by another individual to ascertain their health, evaluate symptoms or conditions and extends the reference of PRO, as defined by the FDA, to include other sources such as patient diaries. Consumers and clinicians consistently report that PRO data are valued, and can aide when deciding between treatment options; therefore an integral part of clinical research. However, little guidance exists for clinical research professionals (CRPs) responsible for collecting PRO data on the best practices to ensure quality data collection so that an accurate assessment of the patient's view is collected. Therefore the purpose of this work was to develop and validate a checklist to guide quality collection of PRO data. The checklist synthesizes best practices from published literature and expert opinions addressing practical and methodological challenges CRPs often encounter when collecting PRO data in research settings. Published by Elsevier Inc.

  14. Highlights of the 2012 research workshop: Using nutrigenomics and metabolomics in clinical nutrition research

    Science.gov (United States)

    The American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.) Research Workshop, "Using Nutrigenomics and Metabolomics in Clinical Nutrition Research," was held on January 21, 2012, in Orlando, Florida. The conference brought together experts in human nutrition who use nutrigenomic and meta...

  15. Prognosis research strategy (PROGRESS) 1: A framework for researching clinical outcomes

    NARCIS (Netherlands)

    H. Hemingway; P. Croft (Peter); P. Perel (Pablo); J. Hayden (Jill); D. Abrams; A. Timmis (Adam); A. Briggs (Andrew); R. Udumyan (Ruzan); K.G.M. Moons (Karel); E.W. Steyerberg (Ewout); I. Roberts (Ian); S. Schroter (Sara); D.G. Altman (Douglas); R.D. Riley (Richard); N. Brunner; A. Hingorani (Aroon); P.A. Kyzas (Panayiotis); N. Malats (Núria); G. Peat; W. Sauerbrei (Willi); D.A.W.M. van der Windt (Daniëlle)

    2013-01-01

    textabstractUnderstanding and improving the prognosis of a disease or health condition is a priority in clinical research and practice. In this article, the authors introduce a framework of four interrelated themes in prognosis research, describe the importance of the first of these themes

  16. Evolution of clinical research: A history before and beyond james lind

    Directory of Open Access Journals (Sweden)

    Arun Bhatt

    2010-01-01

    Full Text Available The evolution of clinical research traverses a long and fascinating journey. From the first recorded trial of legumes in biblical times to the first randomized controlled of trial of streptomycin in 1946, the history of clinical trial covers a wide variety of challenges - scientific, ethical and regulatory. The famous 1747 scurvy trial conducted by James Lind contained most elements of a controlled trial. The UK Medical Research Council′s (MRC trial of patulin for common cold in 1943 was the first double blind controlled trial. This paved the way for the first randomized control trial of streptomycin in pulmonary tuberculosis carried out in 1946 by MRC of the UK. This landmark trial was a model of meticulousness in design and implementation, with systematic enrolment criteria and data collection compared with the ad hoc nature of other contemporary research. Over the years, as the discipline of controlled trials grew in sophistication and influence, the streptomycin trial continues to be referred to as ground breaking. The ethical advances in human protection include several milestones - Nuremberg Code, Declaration of Helsinki, Belmont Report, and 1996, International Conference on Harmonization Good Clinical Practice guidance. In parallel to ethical guidelines, clinical trials started to become embodied in regulation as government authorities began recognizing a need for controlling medical therapies in the early 20th century. As the scientific advances continue to occur, there will be new ethical and regulatory challenges requiring dynamic updates in ethical and legal framework of clinical trials.

  17. Clinical Trial Data as Public Goods: Fair Trade and the Virtual Knowledge Bank as a Solution to the Free Rider Problem - A Framework for the Promotion of Innovation by Facilitation of Clinical Trial Data Sharing among Biopharmaceutical Companies in the Era of Omics and Big Data.

    Science.gov (United States)

    Evangelatos, Nikolaos; Reumann, Matthias; Lehrach, Hans; Brand, Angela

    2016-01-01

    Knowledge in the era of Omics and Big Data has been increasingly conceptualized as a public good. Sharing of de-identified patient data has been advocated as a means to increase confidence and public trust in the results of clinical trials. On the other hand, research has shown that the current research and development model of the biopharmaceutical industry has reached its innovation capacity. In response to that, the biopharmaceutical industry has adopted open innovation practices, with sharing of clinical trial data being among the most interesting ones. However, due to the free rider problem, clinical trial data sharing among biopharmaceutical companies could undermine their innovativeness. Based on the theory of public goods, we have developed a commons arrangement and devised a model, which enables secure and fair clinical trial data sharing over a Virtual Knowledge Bank based on a web platform. Our model uses data as a virtual currency and treats knowledge as a club good. Fair sharing of clinical trial data over the Virtual Knowledge Bank has positive effects on the innovation capacity of the biopharmaceutical industry without compromising the intellectual rights, proprietary interests and competitiveness of the latter. The Virtual Knowledge Bank is a sustainable and self-expanding model for secure and fair clinical trial data sharing that allows for sharing of clinical trial data, while at the same time it increases the innovation capacity of the biopharmaceutical industry. © 2016 S. Karger AG, Basel.

  18. Pediatric patient-reported outcome instruments for research to support medical product labeling: report of the ISPOR PRO good research practices for the assessment of children and adolescents task force.

    Science.gov (United States)

    Matza, Louis S; Patrick, Donald L; Riley, Anne W; Alexander, John J; Rajmil, Luis; Pleil, Andreas M; Bullinger, Monika

    2013-06-01

    Patient-reported outcome (PRO) instruments for children and adolescents are often included in clinical trials with the intention of collecting data to support claims in a medical product label. The purpose of the current task force report is to recommend good practices for pediatric PRO research that is conducted to inform regulatory decision making and support claims made in medical product labeling. The recommendations are based on the consensus of an interdisciplinary group of researchers who were assembled for a task force associated with the International Society for Pharmacoeconomics and Outcomes Research (ISPOR). In those areas in which supporting evidence is limited or in which general principles may not apply to every situation, this task force report identifies factors to consider when making decisions about the design and use of pediatric PRO instruments, while highlighting issues that require further research. Five good research practices are discussed: 1) Consider developmental differences and determine age-based criteria for PRO administration: Four age groups are discussed on the basis of previous research (<5 years old, 5-7 years, 8-11 years, and 12-18 years). These age groups are recommended as a starting point when making decisions, but they will not fit all PRO instruments or the developmental stage of every child. Specific age ranges should be determined individually for each population and PRO instrument. 2) Establish content validity of pediatric PRO instruments: This section discusses the advantages of using children as content experts, as well as strategies for concept elicitation and cognitive interviews with children. 3) Determine whether an informant-reported outcome instrument is necessary: The distinction between two types of informant-reported measures (proxy vs. observational) is discussed, and recommendations are provided. 4) Ensure that the instrument is designed and formatted appropriately for the target age group. Factors to

  19. [Thinking on designation of sham acupuncture in clinical research].

    Science.gov (United States)

    Pan, Li-Jia; Chen, Bo; Zhao, Xue; Guo, Yi

    2014-01-01

    Randomized controlled trials (RCT) is the source of the raw data of evidence-based medicine. Blind method is adopted in most of the high-quality RCT. Sham acupuncture is the main form of blinded in acupuncture clinical trial. In order to improve the quality of acupuncture clinical trail, based on the necessity of sham acupuncture in clinical research, the current situation as well as the existing problems of sham acupuncture, suggestions were put forward from the aspects of new way and new designation method which can be adopted as reference, and factors which have to be considered during the process of implementing. Various subjective and objective factors involving in the process of trial should be considered, and used of the current international standards, try to be quantification, and carry out strict quality monitoring.

  20. Beyond "utilitarianism": maximizing the clinical impact of moral judgment research.

    Science.gov (United States)

    Rosas, Alejandro; Koenigs, Michael

    2014-01-01

    The use of hypothetical moral dilemmas--which pit utilitarian considerations of welfare maximization against emotionally aversive "personal" harms--has become a widespread approach for studying the neuropsychological correlates of moral judgment in healthy subjects, as well as in clinical populations with social, cognitive, and affective deficits. In this article, we propose that a refinement of the standard stimulus set could provide an opportunity to more precisely identify the psychological factors underlying performance on this task, and thereby enhance the utility of this paradigm for clinical research. To test this proposal, we performed a re-analysis of previously published moral judgment data from two clinical populations: neurological patients with prefrontal brain damage and psychopathic criminals. The results provide intriguing preliminary support for further development of this assessment paradigm.

  1. Retention of minority participants in clinical research studies.

    Science.gov (United States)

    Keller, Colleen S; Gonzales, Adelita; Fleuriet, K Jill

    2005-04-01

    Recruitment of minority participants for clinical research studies has been the topic of several analytical works. Yet retention of participants, most notably minority and underserved populations, is less reported and understood, even though these populations have elevated health risks. This article describes two related, intervention-based formative research projects in which researchers used treatment theory to address issues of recruitment and retention of minority women participants in an exercise program to reduce obesity. Treatment theory incorporates a model of health promotion that allows investigators to identify and control sources of extraneous variables. The authors' research demonstrates that treatment theory can improve retention of minority women participants by considering critical inputs, mediating processes, and substantive participant characteristics in intervention design.

  2. Ethics and epistemology of accurate prediction in clinical research.

    Science.gov (United States)

    Hey, Spencer Phillips

    2015-07-01

    All major research ethics policies assert that the ethical review of clinical trial protocols should include a systematic assessment of risks and benefits. But despite this policy, protocols do not typically contain explicit probability statements about the likely risks or benefits involved in the proposed research. In this essay, I articulate a range of ethical and epistemic advantages that explicit forecasting would offer to the health research enterprise. I then consider how some particular confidence levels may come into conflict with the principles of ethical research. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

  3. Single cell analysis contemporary research and clinical applications

    CERN Document Server

    Cossarizza, Andrea

    2017-01-01

    This book highlights the current state of the art in single cell analysis, an area that involves many fields of science – from clinical hematology, functional analysis and drug screening, to platelet and microparticle analysis, marine biology and fundamental cancer research. This book brings together an eclectic group of current applications, all of which have a significant impact on our current state of knowledge. The authors of these chapters are all pioneering researchers in the field of single cell analysis. The book will not only appeal to those readers more focused on clinical applications, but also those interested in highly technical aspects of the technologies. All of the technologies identified utilize unique applications of photon detection systems.

  4. The DSM and Professional Practice: Research, Clinical, and Institutional Perspectives.

    Science.gov (United States)

    Halpin, Michael

    2016-06-01

    How mental illnesses are defined has significant ramifications, given the substantial social and individual repercussions of these conditions. Using actor-network theory, I analyze how mental health professionals use the Diagnostic and Statistical Manual of Mental Disorders (DSM) in their work. Drawing on observations of a neuropsychological laboratory and interviews with 27 professionals (i.e., psychiatrists, psychologists), I investigate how the DSM is used in research, clinical, and institutional work. In research, the DSM influences study design and exclusion/inclusion criteria. In the clinic, the DSM influences how disorders are conceptualized and diagnosed. Institutionally, the DSM aligns the patient-professional encounter to insurance and pharmaceutical interests. I conclude that the DSM operates as multiple, context-specific taxonomies that pervasively influence professional practices, such that all possible actions must orient to DSM criteria, with professionals both a source and an object of institutionalized gaze. © American Sociological Association 2016.

  5. [Current situation of clinical research on impacted premolars].

    Science.gov (United States)

    Liu, Ran-Ran; Tian, Jun

    2018-04-01

    Teeth impaction is a common developmental malformation in oral diseases. Impacted teeth are usually the canines, third molar, central incisors, premolars, and second molars. The prevalence of impaction of maxillary canines and mandibular wisdom teeth is higher than that of other teeth. Most recent studies have focused on the canines and third molars, but research on impacted premolars is limited. In clinical practice, the majority of orthodontic patients require premolar extraction. Thus, impacted premolars play important roles in orthodontic design and prognosis. This article provides an overview of recent research on impacted premolars and summarizes epidemiological features, localizations, and treatments, with the aim of guiding practitioners on orthodontic design and therapy.

  6. Innovative designs for radiation oncology research in clinical trials

    International Nuclear Information System (INIS)

    Rubin, P.; Keys, H.; Salazar, O.

    1987-01-01

    The goals of the research mission are clear: (1) to explore in a logical, systematic, organized, and coordinated fashion those potential therapeutic advances that show promise; (2) to identify, in the laboratory, those models that predict successful combinations of treatment modes; (3) to search for ultimate treatment of programs that improve the therapeutic ratio. The modalities, innovations in treatment, and logic exist; it now rests with meticulous science to show carefully the directions that clinical research should follow in pursuit of the ultimate objective of improving cancer cure rates with less toxicity

  7. A comparative analysis of quality management standards for contract research organisations in clinical trials.

    Science.gov (United States)

    Murray, Elizabeth; McAdam, Rodney

    2007-01-01

    This article compares and contrasts the main quality standards in the highly regulated pharmaceutical industry with specific focus on Good Clinical Practice (GCP), the standard for designing, conducting, recording and reporting clinical trials involving human participants. Comparison is made to ISO quality standards, which can be applied to all industries and types of organisation. The study is then narrowed to that of contract research organisations (CROs) involved in the conduct of clinical trials. The paper concludes that the ISO 9000 series of quality standards can act as a company-wide framework for quality management within such organisations by helping to direct quality efforts on a long-term basis without any loss of compliance. This study is valuable because comparative analysis in this domain is uncommon.

  8. Integrated and Gender-Affirming Transgender Clinical Care and Research

    Science.gov (United States)

    Radix, Asa; Deutsch, Madeline B.

    2016-01-01

    Abstract: Transgender (trans) communities worldwide, particularly those on the trans feminine spectrum, are disproportionately burdened by HIV infection and at risk for HIV acquisition/transmission. Trans individuals represent an underserved, highly stigmatized, and under-resourced population not only in HIV prevention efforts but also in delivery of general primary medical and clinical care that is gender affirming. We offer a model of gender-affirmative integrated clinical care and community research to address and intervene on disparities in HIV infection for transgender people. We define trans terminology, briefly review the social epidemiology of HIV infection among trans individuals, highlight gender affirmation as a key social determinant of health, describe exemplar models of gender-affirmative clinical care in Boston MA, New York, NY, and San Francisco, CA, and offer suggested “best practices” for how to integrate clinical care and research for the field of HIV prevention. Holistic and culturally responsive HIV prevention interventions must be grounded in the lived realities the trans community faces to reduce disparities in HIV infection. HIV prevention interventions will be most effective if they use a structural approach and integrate primary concerns of transgender people (eg, gender-affirmative care and management of gender transition) alongside delivery of HIV-related services (eg, biobehavioral prevention, HIV testing, linkage to care, and treatment). PMID:27429189

  9. The Design and Development of a Technology Based Orientation Manual for Clinical Research Coordinators

    Science.gov (United States)

    Copp, Susan L.

    2010-01-01

    The objective of this research was to use technology to develop an on-line orientation manual for clinical research coordinators. Many clinical research coordinators begin their careers as staff nurses and have little knowledge related to clinical research. As such, when they transition to a career in clinical research they lack the knowledge…

  10. Making Good Decisions in Healthcare with Multi-Criteria Decision Analysis: The Use, Current Research and Future Development of MCDA.

    Science.gov (United States)

    Mühlbacher, Axel C; Kaczynski, Anika

    2016-02-01

    Healthcare decision making is usually characterized by a low degree of transparency. The demand for transparent decision processes can be fulfilled only when assessment, appraisal and decisions about health technologies are performed under a systematic construct of benefit assessment. The benefit of an intervention is often multidimensional and, thus, must be represented by several decision criteria. Complex decision problems require an assessment and appraisal of various criteria; therefore, a decision process that systematically identifies the best available alternative and enables an optimal and transparent decision is needed. For that reason, decision criteria must be weighted and goal achievement must be scored for all alternatives. Methods of multi-criteria decision analysis (MCDA) are available to analyse and appraise multiple clinical endpoints and structure complex decision problems in healthcare decision making. By means of MCDA, value judgments, priorities and preferences of patients, insurees and experts can be integrated systematically and transparently into the decision-making process. This article describes the MCDA framework and identifies potential areas where MCDA can be of use (e.g. approval, guidelines and reimbursement/pricing of health technologies). A literature search was performed to identify current research in healthcare. The results showed that healthcare decision making is addressing the problem of multiple decision criteria and is focusing on the future development and use of techniques to weight and score different decision criteria. This article emphasizes the use and future benefit of MCDA.

  11. A Good Foundation for Number Learning for Five-Year-Olds? An Evaluation of the English Early Learning "Numbers" Goal in the Light of Research

    Science.gov (United States)

    Gifford, Sue

    2014-01-01

    This article sets out to evaluate the English Early Years Foundation Stage Goal for Numbers, in relation to research evidence. The Goal, which sets out to provide "a good foundation in mathematics", has greater breadth of content and higher levels of difficulty than previous versions. Research suggests that the additional expectations…

  12. Accuracy of the MacArthur competence assessment tool for clinical research (MacCAT-CR) for measuring children's competence to consent to clinical research.

    Science.gov (United States)

    Hein, Irma M; Troost, Pieter W; Lindeboom, Robert; Benninga, Marc A; Zwaan, C Michel; van Goudoever, Johannes B; Lindauer, Ramón J L

    2014-12-01

    An objective assessment of children's competence to consent to research participation is currently not possible. Age limits for asking children's consent vary considerably between countries, and, to our knowledge, the correlation between competence and children's age has never been systematically investigated. To test a standardized competence assessment instrument for children by modifying the MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR), to investigate its reliability and validity, and to examine the correlation of its assessment with age and estimate cutoff ages. This prospective study included children and adolescents aged 6 to 18 years in the inpatient and outpatient departments of allergology, gastroenterology, oncology, ophthalmology, and pulmonology from January 1, 2012, through January 1, 2014. Participants were eligible for clinical research studies, including observational studies and randomized clinical trials. Competence judgments by experts aware of the 4 relevant criteria-understanding, appreciation, reasoning, and choice-were used to establish the reference standard. The index test was the MacCAT-CR, which used a semistructured interview format. Interrater reliability, validity, and dimensionality of the MacCAT-CR and estimated cutoff ages for competence. Of 209 eligible patients, we included 161 (mean age, 10.6 years; 47.2% male). Good reproducibility of MacCAT-CR total and subscale scores was observed (intraclass correlation coefficient range, 0.68-0.92). We confirmed unidimensionality of the MacCAT-CR. By the reference standard, we judged 54 children (33.5%) to be incompetent; by the MacCAT-CR, 61 children (37.9%). Criterion-related validity of MacCAT-CR scores was supported by high overall accuracy in correctly classifying children as competent against the reference standard (area under the receiver operating characteristics curve, 0.78). Age was a good predictor of competence on the MacCAT-CR (area under the receiver

  13. Citation analysis may severely underestimate the impact of clinical research as compared to basic research.

    Science.gov (United States)

    van Eck, Nees Jan; Waltman, Ludo; van Raan, Anthony F J; Klautz, Robert J M; Peul, Wilco C

    2013-01-01

    Citation analysis has become an important tool for research performance assessment in the medical sciences. However, different areas of medical research may have considerably different citation practices, even within the same medical field. Because of this, it is unclear to what extent citation-based bibliometric indicators allow for valid comparisons between research units active in different areas of medical research. A visualization methodology is introduced that reveals differences in citation practices between medical research areas. The methodology extracts terms from the titles and abstracts of a large collection of publications and uses these terms to visualize the structure of a medical field and to indicate how research areas within this field differ from each other in their average citation impact. Visualizations are provided for 32 medical fields, defined based on journal subject categories in the Web of Science database. The analysis focuses on three fields: Cardiac & cardiovascular systems, Clinical neurology, and Surgery. In each of these fields, there turn out to be large differences in citation practices between research areas. Low-impact research areas tend to focus on clinical intervention research, while high-impact research areas are often more oriented on basic and diagnostic research. Popular bibliometric indicators, such as the h-index and the impact factor, do not correct for differences in citation practices between medical fields. These indicators therefore cannot be used to make accurate between-field comparisons. More sophisticated bibliometric indicators do correct for field differences but still fail to take into account within-field heterogeneity in citation practices. As a consequence, the citation impact of clinical intervention research may be substantially underestimated in comparison with basic and diagnostic research.

  14. Stem cell therapy clinical research: A regulatory conundrum for academia.

    Science.gov (United States)

    Nagpal, Anjali; Juttner, Chris; Hamilton-Bruce, Monica Anne; Rolan, Paul; Koblar, Simon A

    2017-12-01

    The encouraging pace of discovery and development in the field of regenerative medicine holds tremendous potential for bringing therapies to the clinic that may offer meaningful benefit to patients, particularly in diseases with no or suboptimal therapeutic options. Academic researchers will continue to play a critical role in developing concepts and therapies, thus determining whether regenerative medicine will be able to live up to this potential that clearly excites clinicians, researchers and patients alike. This review summarises recent developments in regulatory frameworks across different countries that aim to ensure adequate oversight of the development of regenerative medicine products, which are unique in structural and functional complexity when compared to traditional chemical drugs and fully characterised biological drugs. It discusses the implications of these developments for researchers aiming to make the challenging transition from laboratory to clinical development of these therapies and considers possible pragmatic solutions that could accelerate this process that is essential to maintain research credibility and ensure patient safety. Copyright © 2016 Elsevier B.V. All rights reserved.

  15. Smart Extraction and Analysis System for Clinical Research.

    Science.gov (United States)

    Afzal, Muhammad; Hussain, Maqbool; Khan, Wajahat Ali; Ali, Taqdir; Jamshed, Arif; Lee, Sungyoung

    2017-05-01

    With the increasing use of electronic health records (EHRs), there is a growing need to expand the utilization of EHR data to support clinical research. The key challenge in achieving this goal is the unavailability of smart systems and methods to overcome the issue of data preparation, structuring, and sharing for smooth clinical research. We developed a robust analysis system called the smart extraction and analysis system (SEAS) that consists of two subsystems: (1) the information extraction system (IES), for extracting information from clinical documents, and (2) the survival analysis system (SAS), for a descriptive and predictive analysis to compile the survival statistics and predict the future chance of survivability. The IES subsystem is based on a novel permutation-based pattern recognition method that extracts information from unstructured clinical documents. Similarly, the SAS subsystem is based on a classification and regression tree (CART)-based prediction model for survival analysis. SEAS is evaluated and validated on a real-world case study of head and neck cancer. The overall information extraction accuracy of the system for semistructured text is recorded at 99%, while that for unstructured text is 97%. Furthermore, the automated, unstructured information extraction has reduced the average time spent on manual data entry by 75%, without compromising the accuracy of the system. Moreover, around 88% of patients are found in a terminal or dead state for the highest clinical stage of disease (level IV). Similarly, there is an ∼36% probability of a patient being alive if at least one of the lifestyle risk factors was positive. We presented our work on the development of SEAS to replace costly and time-consuming manual methods with smart automatic extraction of information and survival prediction methods. SEAS has reduced the time and energy of human resources spent unnecessarily on manual tasks.

  16. Good Mental Health

    Science.gov (United States)

    ... the Eating Disorders Clinical and Research Program, Massachusetts General Hospital Kendra Becker, M.S., Clinical Fellow in Psychology, Department of Psychiatry, Massachusetts General Hospital Michael Kozak, ...

  17. [Mental issues of clinical research interviews in an intercultural context].

    Science.gov (United States)

    Kim, M-S; Derivois, D

    2013-10-01

    The interview is an intersubjective meeting in which the stakes are complex. This frequently used method in social and human sciences research brings to the foreground various mental processes. Despite its clear distinction from the therapeutic interview, due to its purpose and the origin of the request, the research interview generates for both the participant and the researcher unconscious phenomena and contributes to the epistemological reflection inherent to the clinical approach. The aim of this article is to demonstrate that the mental processes mobilized in the participants and in the researcher, who belong to the same culture of origin during the research interview, may be analyzed in four dimensions: intrapsychique, intersubjective, projective and group. So as to illustrate the various mental processes that are engaged, a research conducted in clinical intercultural psychology regarding the adaptive processes and the identity strategies of Korean mothers living in France or in Quebec is used. In order to offer maximum freedom of expression to the participants, the interviews were conducted in Korean, and then translated into French. The intrapsychic dimension is illustrated by an example from the interview with a 44-year-old Korean woman met in Paris. Following the Rogerian theory (1952, 1961), we understand that the participant comes to a coherent reorganization of her own conception throughout the interview, allowing her to speak and to think about her autobiography. From the interaction between two subjectivities, the thought and the discourse are involved in the co-construction of meaning. The understanding of the intersubjective dimension is supported by the theory of Winnicott (1971), developed for the transitional space. Like the mother-child relationship in the game device, the mental permeability available to the researcher is supposed to guarantee the development of the interviewee's confidence. The example of the interview conducted with another

  18. Is audit research? The relationships between clinical audit and social-research.

    Science.gov (United States)

    Hughes, Rhidian

    2005-01-01

    Quality has an established history in health care. Audit, as a means of quality assessment, is well understood and the existing literature has identified links between audit and research processes. This paper reviews the relationships between audit and research processes, highlighting how audit can be improved through the principles and practice of social research. The review begins by defining the audit process. It goes on to explore salient relationships between clinical audit and research, grouped into the following broad themes: ethical considerations, highlighting responsibilities towards others and the need for ethical review for audit; asking questions and using appropriate methods, emphasising transparency in audit methods; conceptual issues, including identifying problematic concepts, such as "satisfaction", and the importance of reflexivity within audit; emphasising research in context, highlighting the benefits of vignettes and action research; complementary methods, demonstrating improvements for the quality of findings; and training and multidisciplinary working, suggesting the need for closer relationships between researchers and clinical practitioners. Audit processes cannot be considered research. Both audit and research processes serve distinct purposes. Attention to the principles of research when conducting audit are necessary to improve the quality of audit and, in turn, the quality of health care.

  19. Clinical Research on Traditional Chinese Medicine compounds and their preparations for Amyotrophic Lateral Sclerosis.

    Science.gov (United States)

    Zhu, Jiayi; Shen, Lan; Lin, Xiao; Hong, Yanlong; Feng, Yi

    2017-12-01

    Amyotrophic lateral sclerosis (ALS) is a chronic, fatal neurodegenerative disease which leads to progressive muscle atrophy and paralysis. In order to summarize the characteristics of Traditional Chinese Medicine compounds and their preparations in the prevention and treatment of ALS through analyzing the mechanism, action site, and symptoms according to effective clinical research. We searched ALS, motor neuron disease, chemical drugs, herbal medicine, Chinese medicine, Traditional Chinese Medicine (TCM), and various combinations of these terms in databases including the PudMed, Springer, Ovid, Google, China National Knowledge Infrastructure, and Wanfang databases. It was found that the chemical drugs almost had not sufficient evidence to show their effectiveness in the treatment of ALS, except RILUZOLE. According to the characteristics of clinical symptoms of ALS, Chinese medicine practitioners believe that this disease belongs to the category of "atrophic disease". In clinical research, many Chinese herbal formulas had good clinical efficacies in the treatment of ALS with multiple targets, multiple links, and few side effects. And four kinds of dialectical treatment had been developed based on Clinical data analysis and the use of dialectical therapy: Benefiting the kidney; Declaring the lungs; Enhancing the Qi; and Dredging the meridian. In this review, we provide an overview of chemical drugs and Traditional Chinese Medicine compound and its preparations in therapy of ALS as well as how they may contribute to the ALS pathogenesis, thereby offering some clues for further studies. Copyright © 2017. Published by Elsevier Masson SAS.

  20. Design, development and deployment of a Diabetes Research Registry to facilitate recruitment in clinical research.

    Science.gov (United States)

    Tan, Meng H; Bernstein, Steven J; Gendler, Stephen; Hanauer, David; Herman, William H

    2016-03-01

    A major challenge in conducting clinical trials/studies is the timely recruitment of eligible subjects. Our aim is to develop a Diabetes Research Registry (DRR) to facilitate recruitment by matching potential subjects interested in research with approved clinical studies using study entry criteria abstracted from their electronic health records (EHR). A committee with expertise in diabetes, quality improvement, information technology, and informatics designed and developed the DRR. Using a hybrid approach, we identified and consented patients interested in research, abstracted their EHRs to assess common eligibility criteria, and contacted them about their interest in participating in specific studies. Investigators submit their requests with study entry criteria to the DRR which then provides a list of potential subjects who may be directly contacted for their study. The DRR meets all local, regional and federal regulatory requirements. After 5 years, the DRR has over 5000 registrants. About 30% have type 1 diabetes and 70% have type 2 diabetes. There are almost equal proportions of men and women. During this period, 31 unique clinical studies from 19 unique investigators requested lists of potential subjects for their studies. Eleven grant applications from 10 unique investigators used aggregated counts of potentially eligible subjects in their applications. The DRR matches potential subjects interested in research with approved clinical studies using study entry criteria abstracted from their EHR. By providing large lists of potentially eligible study subjects quickly, the DRR facilitated recruitment in 31 clinical studies. Copyright © 2016 Elsevier Inc. All rights reserved.

  1. Key factors in children's competence to consent to clinical research.

    Science.gov (United States)

    Hein, Irma M; Troost, Pieter W; Lindeboom, Robert; Benninga, Marc A; Zwaan, C Michel; van Goudoever, Johannes B; Lindauer, Ramón J L

    2015-10-24

    Although law is established on a strong presumption that persons younger than a certain age are not competent to consent, statutory age limits for asking children's consent to clinical research differ widely internationally. From a clinical perspective, competence is assumed to involve many factors including the developmental stage, the influence of parents and peers, and life experience. We examined potential determining factors for children's competence to consent to clinical research and to what extent they explain the variation in competence judgments. From January 1, 2012 through January 1, 2014, pediatric patients aged 6 to 18 years, eligible for clinical research studies were enrolled prospectively at various in- and outpatient pediatric departments. Children's competence to consent was assessed by MacArthur Competence Assessment Tool for Clinical Research. Potential determining child variables included age, gender, intelligence, disease experience, ethnicity and socio-economic status (SES). We used logistic regression analysis and change in explained variance in competence judgments to quantify the contribution of a child variable to the total explained variance. Contextual factors included risk and complexity of the decision to participate, parental competence judgment and the child's or parents decision to participate. Out of 209 eligible patients, 161 were included (mean age, 10.6 years, 47.2 % male). Age, SES, intelligence, ethnicity, complexity, parental competence judgment and trial participation were univariately associated with competence (P competence judgments was 71.5 %. Only age and intelligence significantly and independently explained the variance in competence judgments, explaining 56.6 % and 12.7 % of the total variance respectively. SES, male gender, disease experience and ethnicity each explained less than 1 % of the variance in competence judgments. Contextual factors together explained an extra 2.8 % (P > 0.05). Age is the factor that

  2. Clinical trial network for the promotion of clinical research for rare diseases in Japan: muscular dystrophy clinical trial network.

    Science.gov (United States)

    Shimizu, Reiko; Ogata, Katsuhisa; Tamaura, Akemi; Kimura, En; Ohata, Maki; Takeshita, Eri; Nakamura, Harumasa; Takeda, Shin'ichi; Komaki, Hirofumi

    2016-07-11

    Duchenne muscular dystrophy (DMD) is the most commonly inherited neuromuscular disease. Therapeutic agents for the treatment of rare disease, namely "orphan drugs", have recently drawn the attention of researchers and pharmaceutical companies. To ensure the successful conduction of clinical trials to evaluate novel treatments for patients with rare diseases, an appropriate infrastructure is needed. One of the effective solutions for the lack of infrastructure is to establish a network of rare diseases. To accomplish the conduction of clinical trials in Japan, the Muscular dystrophy clinical trial network (MDCTN) was established by the clinical research group for muscular dystrophy, including the National Center of Neurology and Psychiatry, as well as national and university hospitals, all which have a long-standing history of research cooperation. Thirty-one medical institutions (17 national hospital organizations, 10 university hospitals, 1 national center, 2 public hospitals, and 1 private hospital) belong to this network and collaborate to facilitate clinical trials. The Care and Treatment Site Registry (CTSR) calculates and reports the proportion of patients with neuromuscular diseases in the cooperating sites. In total, there are 5,589 patients with neuromuscular diseases in Japan and the proportion of patients with each disease is as follows: DMD, 29 %; myotonic dystrophy type 1, 23 %; limb girdle muscular dystrophy, 11 %; Becker muscular dystrophy, 10 %. We work jointly to share updated health care information and standardized evaluations of clinical outcomes as well. The collaboration with the patient registry (CTSR), allows the MDCTN to recruit DMD participants with specific mutations and conditions, in a remarkably short period of time. Counting with a network that operates at a national level is important to address the corresponding national issues. Thus, our network will be able to contribute with international research activity, which can lead to

  3. Emerging uses of patient generated health data in clinical research.

    Science.gov (United States)

    Wood, William A; Bennett, Antonia V; Basch, Ethan

    2015-05-01

    Recent advancements in consumer directed personal computing technology have led to the generation of biomedically-relevant data streams with potential health applications. This has catalyzed international interest in Patient Generated Health Data (PGHD), defined as "health-related data - including health history, symptoms, biometric data, treatment history, lifestyle choices, and other information-created, recorded, gathered, or inferred by or from patients or their designees (i.e. care partners or those who assist them) to help address a health concern."(Shapiro et al., 2012) PGHD offers several opportunities to improve the efficiency and output of clinical trials, particularly within oncology. These range from using PGHD to understand mechanisms of action of therapeutic strategies, to understanding and predicting treatment-related toxicity, to designing interventions to improve adherence and clinical outcomes. To facilitate the optimal use of PGHD, methodological research around considerations related to feasibility, validation, measure selection, and modeling of PGHD streams is needed. With successful integration, PGHD can catalyze the application of "big data" to cancer clinical research, creating both "n of 1" and population-level observations, and generating new insights into the nature of health and disease. Copyright © 2014 Federation of European Biochemical Societies. Published by Elsevier B.V. All rights reserved.

  4. Ethical considerations in clinical training, care and research in psychopharmacology.

    Science.gov (United States)

    Strous, Rael D

    2011-04-01

    Psychopharmacology is a powerful tool in psychiatry; however, it is one that demands responsibility in order to deal with the ethical complexities that accompany advances in the field. It is important that questions are asked and that ethical mindfulness and sensitivity are developed along with clinical skills. In order to cultivate and deepen ethical awareness and subsequently solve issues in optimal fashion, investment should be made in the development of an ethical decision-making process as well as in education in the ethics of psychopharmacology to trainees in the field at all stages of their educational development. A clear approach to identifying ethical problems, engaging various ethical concepts in considering solutions and then applying these principles in problem resolution is demanded. An openness in identifying and exploring issues has become crucial to the future development and maturation of psychopharmacologists, both research and clinical. Consideration must be given to the social implications of psychopharmacological practice, with the best interests of patients always paramount. From both a research and clinical perspective, psychopharmacology has to be practised with fairness, sensitivity and ethical relevance to all. While ethical issues related to psychopharmacological practice are varied and plentiful, this review focuses on advances in technology and biological sciences, personal integrity, special populations, and education and training.

  5. 78 FR 60885 - Proposed Collection; 60-Day Notice Request: Application Process for Clinical Research Training...

    Science.gov (United States)

    2013-10-02

    ... Notice Request: Application Process for Clinical Research Training and Medical Education at the Clinical... Research Training and Medical Education, NIH Clinical Center, 10 Center Drive, MSC 1158, Bethesda, MD 20892... Process for Clinical Research Training and Medical Education at the Clinical Center and its Impact on...

  6. 78 FR 79703 - Submission for OMB Review; 30-Day Comment Request: Application Process for Clinical Research...

    Science.gov (United States)

    2013-12-31

    ...; 30-Day Comment Request: Application Process for Clinical Research Training and Medical Education at..., MD, Deputy Director, Office of Clinical Research Training and Medical Education, NIH Clinical Center... Clinical Research Training and Medical Education at the Clinical Center and its Impact on Course and...

  7. Considering Actionability at the Participant's Research Setting Level for Anticipatable Incidental Findings from Clinical Research.

    Science.gov (United States)

    Ortiz-Osorno, Alberto Betto; Ehler, Linda A; Brooks, Judith

    2015-01-01

    Determining what constitutes an anticipatable incidental finding (IF) from clinical research and defining whether, and when, this IF should be returned to the participant have been topics of discussion in the field of human subject protections for the last 10 years. It has been debated that implementing a comprehensive IF-approach that addresses both the responsibility of researchers to return IFs and the expectation of participants to receive them can be logistically challenging. IFs have been debated at different levels, such as the ethical reasoning for considering their disclosure or the need for planning for them during the development of the research study. Some authors have discussed the methods for re-contacting participants for disclosing IFs, as well as the relevance of considering the clinical importance of the IFs. Similarly, other authors have debated about when IFs should be disclosed to participants. However, no author has addressed how the "actionability" of the IFs should be considered, evaluated, or characterized at the participant's research setting level. This paper defines the concept of "Actionability at the Participant's Research Setting Level" (APRSL) for anticipatable IFs from clinical research, discusses some related ethical concepts to justify the APRSL concept, proposes a strategy to incorporate APRSL into the planning and management of IFs, and suggests a strategy for integrating APRSL at each local research setting. © 2015 American Society of Law, Medicine & Ethics, Inc.

  8. Assessing Clinical Research Capacity in Vietnam: A Framework for Strengthening Capability for Clinical Trials in Developing Countries.

    Science.gov (United States)

    Kagan, Jonathan; Giang, Dao Duc; Iademarco, Michael F; Phung, Van Tt; Lau, Chuen-Yen; Quang, Nguyen Ngo

    2016-01-01

    Although improving health systems promises important benefits, most developing nations lack the resources to support nationally driven clinical research. Strengthened clinical research capacity can advance national health goals by supporting greater autonomy in aligning research with national priorities. From March through June 2010, we assessed six elements of clinical research capacity in Vietnam: research agenda; clinical investigators and biostatisticians; donors and sponsors; community involvement; scientific, ethical, safety, and quality oversight; and clinical research institutions. Assessments were drawn from interviews with investigators, Ministry of Health staff members, nongovernment organizations, and U.S. Mission staff members, and document review. Observations and recommendations were shared with collaborators. Reassessment in 2015 found growth in the number of clinical trials, improved regulation in human subjects protection and community engagement, and modest advances in research agenda setting. Training and investment in institutions remain challenging. A framework for assessing clinical research capacity can affirm strengths and weaknesses and guide the coordination of capacity-building efforts.

  9. Is performance in pre-clinical assessment a good predictor of the final Doctor of Medicine grade?

    Science.gov (United States)

    Al-Wardy, Nadia M; Rizvi, Syed G; Bayoumi, Riad A

    2009-12-01

    To investigate if any correlation exists between students' grades on their final doctor of Medicine (MD) assessment and their overall preclinical grade point average (GPA) and its component parts. Student data available from the Deanship of Admissions and Registration were analyzed. Pearson correlation coefficient was obtained to assess the degree of linear relationship between performance in the preclinical and the MD assessment of 529 students who graduated from the College of Medicine and Health Sciences, Sultan Qaboos University, Al-Khoud, Oman from June 1998 to June 2005. Simple and multiple regression analyses were performed to evaluate individual and combined impact of the preclinical courses' grades on MD grades. Preclinical GPA correlated highly with MD GPA (r=0.641). The science component taught early in the preclinical phase correlated more strongly (r=0.457) than student electives (r=0.246). This correlation was better in the good English group. Students' performance, however, was best in electives, but worst in English. Most students who had low MD GPA (2.5, and limiting the credit hour requirement of electives by the College seems to be justified.

  10. The Community-First Land-Centred Theoretical Framework: Bringing a "Good Mind" to Indigenous Education Research?

    Science.gov (United States)

    Styres, Sandra D.; Zinga, Dawn M.

    2013-01-01

    This article introduces an emergent research theoretical framework, the community-first Land-centred research framework. Carefully examining the literature within Indigenous educational research, we noted the limited approaches for engaging in culturally aligned and relevant research within Indigenous communities. The community-first Land-centred…

  11. Evaluating the risks of clinical research: direct comparative analysis.

    Science.gov (United States)

    Rid, Annette; Abdoler, Emily; Roberson-Nay, Roxann; Pine, Daniel S; Wendler, David

    2014-09-01

    Many guidelines and regulations allow children and adolescents to be enrolled in research without the prospect of clinical benefit when it poses minimal risk. However, few systematic methods exist to determine when research risks are minimal. This situation has led to significant variation in minimal risk judgments, raising concern that some children are not being adequately protected. To address this concern, we describe a new method for implementing the widely endorsed "risks of daily life" standard for minimal risk. This standard defines research risks as minimal when they do not exceed the risks posed by daily life activities or routine examinations. This study employed a conceptual and normative analysis, and use of an illustrative example. Different risks are composed of the same basic elements: Type, likelihood, and magnitude of harm. Hence, one can compare the risks of research and the risks of daily life by comparing the respective basic elements with each other. We use this insight to develop a systematic method, direct comparative analysis, for implementing the "risks of daily life" standard for minimal risk. The method offers a way of evaluating research procedures that pose the same types of risk as daily life activities, such as the risk of experiencing anxiety, stress, or other psychological harm. We thus illustrate how direct comparative analysis can be applied in practice by using it to evaluate whether the anxiety induced by a respiratory CO2 challenge poses minimal or greater than minimal risks in children and adolescents. Direct comparative analysis is a systematic method for applying the "risks of daily life" standard for minimal risk to research procedures that pose the same types of risk as daily life activities. It thereby offers a method to protect children and adolescents in research, while ensuring that important studies are not blocked because of unwarranted concerns about research risks.

  12. A 50-year research journey. From laboratory to clinic.

    Science.gov (United States)

    Ross, John

    2009-01-01

    Prior important research is not always cited, exemplified by Oswald Avery's pioneering discovery that DNA is the genetic transforming factor; it was not cited by Watson and Crick 10 years later. My first laboratory research (National Institutes of Health 1950s) resulted in the clinical development of transseptal left heart catheterization. Laboratory studies on cardiac muscle mechanics in normal and failing hearts led to the concept of afterload mismatch with limited preload reserve. At the University of California, San Diego in La Jolla (1968) laboratory experiments on coronary artery reperfusion after sustained coronary occlusion showed salvage of myocardial tissue, a potential treatment for acute myocardial infarction proven in clinical trials of thrombolysis 14 years later. Among 60 trainees who worked with me in La Jolla, one-third were Japanese and some of their important laboratory experiments are briefly recounted, beginning with Sasayama, Tomoike and Shirato in the 1970 s. Recently, we developed a method for cardiac gene transfer, and subsequently we showed that gene therapy for the defect in cardiomyopathic hamsters halted the progression of advanced disease. Cardiovascular research and medicine are producing continuing advances in technologies for gene transfer and embryonic stem cell transplantation, targeting of small molecules, and tissue and organ engineering.

  13. Booklet of the Research Institute of Clinical Medicine

    International Nuclear Information System (INIS)

    Todua, F.; Jgamadze, N.; Todua, N.; Beriashvili, Z.; Chelishvili, M.; Todua, I.; Chovelidze, Sh. et al.

    2012-01-01

    Research Institute of Clinical Medicine is one of the biggest university diagnostic and treatment centre in Georgia with unique modern diagnostic and treatment apparatus. The institute is acknowledged as a leader in various trends of radiology and surgery. The Research Institute of Clinical Medicine was founded in 1991. It is the leading scientific establishment in the field of medicine. The scientific-research work of the Institute is coordinated by the National Academy of Sciences of Georgia. The main scientific trend of the Institute is the Early Complex Diagnostics and Treatment. The scientific activity of the Institute is led by the Scientific Council. Institute achieved remarkable success since its foundation: It has been defended 56 theses for Candidate of Medical Sciences and 16 for Doctor of Medical Sciences; About 30 post-graduate students and more than 200 radiologists have taken training courses in radiology. Nowadays they work in different regions of Georgia, 21 inventions took out patents. It has been published 2000 scientific works and 9 monographs. (authors)

  14. The importance of clinical case reports in research

    Directory of Open Access Journals (Sweden)

    Ricardo Pineda-Leguízamo

    2018-04-01

    Full Text Available Clinical case reports correspond to articles that have the lowest level of evidence within different research trials. However, not only are they common and significant in the medical field, but they have often been the basis the generation of research. The purpose of their publication can be scientific or educational. In general terms, the discovery of new diseases, the presentation of rare diseases, unusual forms of common diseases, the complications of a common treatment, or the effect (beneficial or adverse of a treatment, among other things, are narrated in these documents. Clinical case reports continue to be one of the most important sources of knowledge. The advent of a standardized guideline for the creation of this type of reports allows homogenizing the form and content of the cases intended to be described in the near future and, furthermore, will enable authors to have a reference when preparing this type of publications. Case reports are valuable resources of new and unusual information that can encourage and serve to conduct future research studies with a higher level of evidence.

  15. Integrative Mental Health (IMH): paradigm, research, and clinical practice.

    Science.gov (United States)

    Lake, James; Helgason, Chanel; Sarris, Jerome

    2012-01-01

    This paper provides an overview of the rapidly evolving paradigm of "Integrative Mental Health (IMH)." The paradigm of contemporary biomedical psychiatry and its contrast to non-allopathic systems of medicine is initially reviewed, followed by an exploration of the emerging paradigm of IMH, which aims to reconcile the bio-psycho-socio-spiritual model with evidence-based methods from traditional healing practices. IMH is rapidly transforming conventional understandings of mental illness and has significant positive implications for the day-to-day practice of mental health care. IMH incorporates mainstream interventions such as pharmacologic treatments, psychotherapy, and psychosocial interventions, as well as alternative therapies such as acupuncture, herbal and nutritional medicine, dietary modification, meditation, etc. Two recent international conferences in Europe and the United States show that interest in integrative mental health care is growing rapidly. In response, the International Network of Integrative Mental Health (INIMH: www.INIMH.org) was established in 2010 with the objective of creating an international network of clinicians, researchers, and public health advocates to advance a global agenda for research, education, and clinical practice of evidence-based integrative mental health care. The paper concludes with a discussion of emerging opportunities for research in IMH, and an exploration of potential clinical applications of integrative mental health care. Copyright © 2012 Elsevier Inc. All rights reserved.

  16. The Effects of Bad and Good News on Newspaper Image and Community Image. A Report from the Communications Research Center.

    Science.gov (United States)

    Haskins , Jack B.

    A study tested the hypotheses that the relative amount of bad news and good news in a newspaper would have corresponding effects on perceptions of the newspaper's community of origin and of the newspaper itself. Five different versions of a realistic four-page newspaper were created, in which treatment of the news stories ranged from an…

  17. Animal models of osteogenesis imperfecta: applications in clinical research

    Directory of Open Access Journals (Sweden)

    Enderli TA

    2016-09-01

    Full Text Available Tanya A Enderli, Stephanie R Burtch, Jara N Templet, Alessandra Carriero Department of Biomedical Engineering, Florida Institute of Technology, Melbourne, FL, USA Abstract: Osteogenesis imperfecta (OI, commonly known as brittle bone disease, is a genetic disease characterized by extreme bone fragility and consequent skeletal deformities. This connective tissue disorder is caused by mutations in the quality and quantity of the collagen that in turn affect the overall mechanical integrity of the bone, increasing its vulnerability to fracture. Animal models of the disease have played a critical role in the understanding of the pathology and causes of OI and in the investigation of a broad range of clinical therapies for the disease. Currently, at least 20 animal models have been officially recognized to represent the phenotype and biochemistry of the 17 different types of OI in humans. These include mice, dogs, and fish. Here, we describe each of the animal models and the type of OI they represent, and present their application in clinical research for treatments of OI, such as drug therapies (ie, bisphosphonates and sclerostin and mechanical (ie, vibrational loading. In the future, different dosages and lengths of treatment need to be further investigated on different animal models of OI using potentially promising treatments, such as cellular and chaperone therapies. A combination of therapies may also offer a viable treatment regime to improve bone quality and reduce fragility in animals before being introduced into clinical trials for OI patients. Keywords: OI, brittle bone, clinical research, mouse, dog, zebrafish

  18. Henry Beecher's Contributions to the Ethics of Clinical Research.

    Science.gov (United States)

    Veatch, Robert M

    2016-01-01

    In the 1950s and '60s, Henry Beecher pioneered the discussion of the ethics of clinical research, leading eventually to the publication of the famous New England Journal of Medicine article summarizing 22 research studies that Beecher suggests were unethical. Those studies generally showed a pattern of posing serious risks to subjects without anticipated proportional benefit. Beecher famously claimed that the problem was not that researchers were malicious or evil; rather, he claimed the problem was they manifested thoughtlessness or carelessness. He called for more rigorous self-scrutiny rather than public review.This article argues that Beecher's reliance on conscientious investigators is problematic. In particular, it focuses on benefits and harms to the exclusion of other moral criteria. However, both research subjects and public regulators are also concerned about autonomy and the consent requirement, confidentiality, and fairness in subject selection and research design. The movement in the 1970s toward more public scrutiny was critical, even though Beecher was right in holding that it was not "vicious disregard for subject welfare" that explained unethical protocols.

  19. Clinical research involving minors in international and serbian regulations.

    Science.gov (United States)

    Planojević, Nina; Zivojinović, Dragica

    2013-07-01

    Participation in clinical trials can be useful for the health of a person, in who it is conducted, but it does not have to be - it can even be harmful. Therefore, primary motive to accept such risk is humanity and human wish to contribute to the progress of medicine; this is expressed by personal consent. The consent, however, can be an expression of personal humanity, and for this, it is not logical that someone can give consent on behalf of someone else, as it is done by a legally authorized representative on behalf of a minor. Therefore, authors raise 3 questions: What are the reasons to consider representative's consent acceptable? How should a model of regulations look like in order to provide the most complete possible protection to a minor? Is actual regulation of minors' position within international and Serbian law, analyzed here by authors for their specific solutions, acceptable? Representative's consent is acceptable only for therapeutic research, because these can bring benefits to everyone's health, including a minor in which those are conducted - this is an acceptable (secondary) motive of participation in the research. Expression of humanity on other's behalf, typical for non-therapeutic research, is not acceptable; this makes ban of minors' participation in non-therapeutic research more appropriate regulation model. International regulations are not in accordance to results presented in the paper for allowing participation of minors both in therapeutic and non-therapeutic research. Serbian regulation is closer to the most acceptable regulation model.

  20. Health claims on foods: challenge for clinical research companies

    Directory of Open Access Journals (Sweden)

    Essi Sarkkinen

    2012-06-01

    Full Text Available Background The Nutrition and Health Claim Regulation 1924/2006/EC, together with EFSA guidances on the scientific requirements for different type of health claims, is setting the basis for health claim substantiation in the EU. Aim The aim of this presentation is to bring up the key challenges that the food industry and clinical research organizations are facing when meeting these requirements. Results and discussion Key issues in clinical research planning to meet the requirements set for the health claim substantiation are: (1 Selection of right outcome markers since the selection of outcome marker defines actually the formulation of the health claim to be used on food or food ingredient. (2 Selection of right target population since that determines the target consumer group for the food with a health claim. (3 Selection of dose regime and food matrices used since these largely determine the conditions set for the use of the health claim. One of the major challenges in health claim substantiation is the deviant approach to risk factors or biomarkers. From the regulation point of view, a single risk factor approach is emphasized, but from the clinical and scientific point of view the pattern of different risk markers or biomarkers could, in some cases, be a more relevant choice to reflect the final health outcome. This is especially the case in the nutrition and health area because we are often dealing with weak but multiple health effects of certain food items or ingredients. Also the lack of validated well-established biomarkers potent to be affected by diet is a challenge in health claim substantiation.The selection of right target population is often a compromise between choosing a more potential target group to obtain efficacy (i.e. risk factors elevated vs. patient groups and choosing a rationale to generalize the results to wider population (target consumer group.The selection of optimal dosing regime and matrices for a clinical study is

  1. Conjoint analysis applications in health--a checklist: a report of the ISPOR Good Research Practices for Conjoint Analysis Task Force.

    Science.gov (United States)

    Bridges, John F P; Hauber, A Brett; Marshall, Deborah; Lloyd, Andrew; Prosser, Lisa A; Regier, Dean A; Johnson, F Reed; Mauskopf, Josephine

    2011-06-01

    The application of conjoint analysis (including discrete-choice experiments and other multiattribute stated-preference methods) in health has increased rapidly over the past decade. A wider acceptance of these methods is limited by an absence of consensus-based methodological standards. The International Society for Pharmacoeconomics and Outcomes Research (ISPOR) Good Research Practices for Conjoint Analysis Task Force was established to identify good research practices for conjoint-analysis applications in health. The task force met regularly to identify the important steps in a conjoint analysis, to discuss good research practices for conjoint analysis, and to develop and refine the key criteria for identifying good research practices. ISPOR members contributed to this process through an extensive consultation process. A final consensus meeting was held to revise the article using these comments, and those of a number of international reviewers. Task force findings are presented as a 10-item checklist covering: 1) research question; 2) attributes and levels; 3) construction of tasks; 4) experimental design; 5) preference elicitation; 6) instrument design; 7) data-collection plan; 8) statistical analyses; 9) results and conclusions; and 10) study presentation. A primary question relating to each of the 10 items is posed, and three sub-questions examine finer issues within items. Although the checklist should not be interpreted as endorsing any specific methodological approach to conjoint analysis, it can facilitate future training activities and discussions of good research practices for the application of conjoint-analysis methods in health care studies. Copyright © 2011 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

  2. Good prognosis of postpartum lower limb sensorimotor deficit: a combined clinical, electrophysiological, and radiological follow-up.

    Science.gov (United States)

    Richard, A; Vellieux, G; Abbou, S; Benifla, J L; Lozeron, P; Kubis, N

    2017-03-01

    Postpartum lower limb motor and/or sensory deficit is an uncommon obstetrical complication. We aimed to identify its incidence, etiology, and precipitating factors, as well as the neurological prognosis by retrospectively analyzing the successive neurological evaluations, electrophysiological, and MRI data from all the consecutive patients with postpartum motor and/or sensory deficits of the lower limbs referred from the Lariboisière Obstetrical Department to the Lariboisière Neurophysiology Department, from January 2012 to June 2016, as well as data concerning labor and morphological characteristics of mother and baby. Thirteen patients (0.11% of the parturient women in the Lariboisière hospital) were included. Eight (62%) had lumbosacral plexopathy. Symptoms followed a first vaginal delivery in 10/13 patients (77%), in patients who were mostly overweight (mean patient BMI before pregnancy 25.6 ± 3.2 kg/m 2 ). Labor duration was slightly longer than average (mean labor duration 8.9 ± 2.9 h). No other potentially precipitating factor was identified. Recovery was good in all patients, 7/11 (64%) made a rapid full recovery (mean recovery time 5 ± 2.5 weeks excluding one patient who had a normal neurological examination at 2 weeks but still complained of foot weakness that fully recovered in 1 year), and a minority (4/11, 36%) still complained of minor symptoms at time of follow-up, but showed marked improvement. New mothers presenting postpartum lower limb nerve injury should, therefore, be reassured.

  3. Interactive Voice/Web Response System in clinical research.

    Science.gov (United States)

    Ruikar, Vrishabhsagar

    2016-01-01

    Emerging technologies in computer and telecommunication industry has eased the access to computer through telephone. An Interactive Voice/Web Response System (IxRS) is one of the user friendly systems for end users, with complex and tailored programs at its backend. The backend programs are specially tailored for easy understanding of users. Clinical research industry has experienced revolution in methodologies of data capture with time. Different systems have evolved toward emerging modern technologies and tools in couple of decades from past, for example, Electronic Data Capture, IxRS, electronic patient reported outcomes, etc.

  4. Establishment of a research pharmacy to support Ebola clinical research in Liberia.

    Science.gov (United States)

    Pierson, Jerome F; Kirchoff, Matthew Carl; Tyee, Rev Tijli; Montello, Michael J; Rhie, Julie K

    This article describes the establishment of a research pharmacy to support the Partnership for Research on Ebola Vaccines in Liberia (PREVAIL) vaccine study for Ebola virus disease. This article describes the establishment of the pharmacy element to support the overall research program during an Ebola outbreak in Monrovia, Liberia, in 2014 and 2015. The need for the rapid establishment of infrastructure to support the Liberia-United States joint clinical research partnership in response to the emerging Ebola virus disease provided the opportunity for collaboration among Liberian and U.S. pharmacists. Resource austere and research naïve. Research pharmacy prepared and randomized 1500 vaccinations in support of PREVAIL. Experiences of the Liberian and U.S. pharmacists involved in the program are described. The partnership was successful in the conduct of the study. More importantly, the capacity for Liberian pharmacists to support clinical research was established. In addition, the U.S. team learned several important lessons that will help prepare them for responding to research needs in future infectious disease outbreaks. Published by Elsevier Inc.

  5. Magnetic resonance spectroscopy in pediatric neuroradiology: clinical and research applications

    International Nuclear Information System (INIS)

    Panigrahy, Ashok; Nelson, Marvin D.; Blueml, Stefan

    2010-01-01

    Magnetic resonance spectroscopy (MRS) offers a unique, noninvasive approach to assess pediatric neurological abnormalities at microscopic levels by quantifying cellular metabolites. The most widely available MRS method, proton ( 1 H; hydrogen) spectroscopy, is FDA approved for general use and can be ordered by clinicians for pediatric neuroimaging studies if indicated. There are a multitude of both acquisition and post-processing methods that can be used in the implementation of MR spectroscopy. MRS in pediatric neuroimaging is challenging to interpret because of dramatic normal developmental changes that occur in metabolites, particularly in the first year of life. Still, MRS has been proven to provide additional clinically relevant information for several pediatric neurological disease processes such as brain tumors, infectious processes, white matter disorders, and neonatal injury. MRS can also be used as a powerful quantitative research tool. In this article, specific research applications using MRS will be demonstrated in relation to neonatal brain injury and pediatric brain tumor imaging. (orig.)

  6. The bad apple effect and social value orientation in public-goods dilemmas: replication and extension of research findings.

    Science.gov (United States)

    Wu, Song; Sun, Jiaqing; Cai, Wei; Jin, Shenghua

    2014-06-01

    Two studies were conducted to replicate and extend previous findings on the effect of uncooperative behavior on group cooperation (the "bad apple" effect). Study 1 (56 women, 40 men; M age = 23.5 yr.) manipulated information about contributions from the bad apple, controlling for overall contributions to a group account. Study 2 (50 women, 34 men; M age = 20.4 yr.) compared the effects of a bad apple and a good apple on cooperation. The social value orientation of participants was measured to explore individual differences in the bad apple effect. The results revealed a bad apple (a) decreased cooperation among individuals with proself and prosocial orientations in Study 1, and (b) had a greater effect than a good apple on those who were proself compared to prosocial in Study 2.

  7. Can emergency medicine research benefit from adaptive design clinical trials?

    Science.gov (United States)

    Flight, Laura; Julious, Steven A; Goodacre, Steve

    2017-04-01

    Adaptive design clinical trials use preplanned interim analyses to determine whether studies should be stopped or modified before recruitment is complete. Emergency medicine trials are well suited to these designs as many have a short time to primary outcome relative to the length of recruitment. We hypothesised that the majority of published emergency medicine trials have the potential to use a simple adaptive trial design. We reviewed clinical trials published in three emergency medicine journals between January 2003 and December 2013. We determined the proportion that used an adaptive design as well as the proportion that could have used a simple adaptive design based on the time to primary outcome and length of recruitment. Only 19 of 188 trials included in the review were considered to have used an adaptive trial design. A total of 154/165 trials that were fixed in design had the potential to use an adaptive design. Currently, there seems to be limited uptake in the use of adaptive trial designs in emergency medicine despite their potential benefits to save time and resources. Failing to take advantage of adaptive designs could be costly to patients and research. It is recommended that where practical and logistical considerations allow, adaptive designs should be used for all emergency medicine clinical trials. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

  8. Patient registries: useful tools for clinical research in myasthenia gravis.

    Science.gov (United States)

    Baggi, Fulvio; Mantegazza, Renato; Antozzi, Carlo; Sanders, Donald

    2012-12-01

    Clinical registries may facilitate research on myasthenia gravis (MG) in several ways: as a source of demographic, clinical, biological, and immunological data on large numbers of patients with this rare disease; as a source of referrals for clinical trials; and by allowing rapid identification of MG patients with specific features. Physician-derived registries have the added advantage of incorporating diagnostic and treatment data that may allow comparison of outcomes from different therapeutic approaches, which can be supplemented with patient self-reported data. We report the demographic analysis of MG patients in two large physician-derived registries, the Duke MG Patient Registry, at the Duke University Medical Center, and the INNCB MG Registry, at the Istituto Neurologico Carlo Besta, as a preliminary study to assess the consistency of the two data sets. These registries share a common structure, with an inner core of common data elements (CDE) that facilitate data analysis. The CDEs are concordant with the MG-specific CDEs developed under the National Institute of Neurological Disorders and Stroke Common Data Elements Project. © 2012 New York Academy of Sciences.

  9. [Research reveals a market for a veterinary behaviour clinic].

    Science.gov (United States)

    Jonckheer-Sheehy, Valerie; Endenburg, Nienke

    2009-11-01

    An enquiry into the requirement of a university veterinary behaviour clinic in The Netherlands revealed that there is a clear call for such a service. The specific demands and wishes of first line practicing veterinarians and companion animal owners were investigated. The research revealed that veterinarians are regular confronted with behaviour problems in companion animals and that they are willing to refer these cases to the University. They also expressed their need for access to continuing professional development opportunities in the field of veterinary behavioural medicine (which is something that most veterinary behaviour clinics associated with veterinary faculties provide). The demand from companion animal owners was also examined. It can be concluded that a large number of them had animals with behaviour problems and that they were willing to seek veterinary advice on these matters. In response to the above mentioned demands the University of Utrecht will open a veterinary behaviour clinic, providing high quality service for animals, their owners and the referring veterinarians. This service will be based on sound scientific practice and delivered by both veterinarians specialised in this field and recognised animal behaviour therapists.

  10. Recent theoretical, neural, and clinical advances in sustained attention research.

    Science.gov (United States)

    Fortenbaugh, Francesca C; DeGutis, Joseph; Esterman, Michael

    2017-05-01

    Models of attention often distinguish among attention subtypes, with classic models separating orienting, switching, and sustaining functions. Compared with other forms of attention, the neurophysiological basis of sustaining attention has received far less notice, yet it is known that momentary failures of sustained attention can have far-ranging negative effects in healthy individuals, and lasting sustained attention deficits are pervasive in clinical populations. In recent years, however, there has been increased interest in characterizing moment-to-moment fluctuations in sustained attention, in addition to the overall vigilance decrement, and understanding how these neurocognitive systems change over the life span and across various clinical populations. The use of novel neuroimaging paradigms and statistical approaches has allowed for better characterization of the neural networks supporting sustained attention and has highlighted dynamic interactions within and across multiple distributed networks that predict behavioral performance. These advances have also provided potential biomarkers to identify individuals with sustained attention deficits. These findings have led to new theoretical models explaining why sustaining focused attention is a challenge for individuals and form the basis for the next generation of sustained attention research, which seeks to accurately diagnose and develop theoretically driven treatments for sustained attention deficits that affect a variety of clinical populations. © 2017 New York Academy of Sciences.

  11. Recent theoretical, neural, and clinical advances in sustained attention research

    Science.gov (United States)

    Fortenbaugh, Francesca C.; DeGutis, Joseph; Esterman, Michael

    2017-01-01

    Models of attention often distinguish between attention subtypes, with classic models separating orienting, switching, and sustaining functions. Compared to other forms of attention, the neurophysiological basis of sustaining attention has received far less attention yet it is known that momentary failures of sustained attention can have far ranging negative impacts in healthy individuals and lasting sustained attention deficits are pervasive in clinical populations. In recent years, however, there has been increased interest in characterizing moment-to-moment fluctuations in sustained attention in addition to the overall vigilance decrement and understanding how these neurocognitive systems change over the lifespan and across various clinical populations. The use of novel neuroimaging paradigms and statistical approaches has allowed for better characterization of the neural networks supporting sustained attention, and highlighted dynamic interactions within and across multiple distributed networks that predict behavioral performance. These advances have also provided potential biomarkers to identify individuals with sustained attention deficits. These findings have led to new theoretical models of why sustaining focused attention is a challenge for individuals and form the basis for the next generation of sustained attention research, which seeks to accurately diagnose and develop theoretically-driven treatments for sustained attention deficits that affect a variety of clinical populations. PMID:28260249

  12. Basics of case report form designing in clinical research

    Directory of Open Access Journals (Sweden)

    Shantala Bellary

    2014-01-01

    Full Text Available Case report form (CRF is a specialized document in clinical research. It should be study protocol driven, robust in content and have material to collect the study specific data. Though paper CRFs are still used largely, use of electronic CRFs (eCRFS are gaining popularity due to the advantages they offer such as improved data quality, online discrepancy management and faster database lock etc. Main objectives behind CRF development are preserving and maintaining quality and integrity of data. CRF design should be standardized to address the needs of all users such as investigator, site coordinator, study monitor, data entry personnel, medical coder and statistician. Data should be organized in a format that facilitates and simplifies data analysis. Collection of large amount of data will result in wasted resources in collecting and processing it and in many circumstances, will not be utilized for analysis. Apart from that, standard guidelines should be followed while designing the CRF. CRF completion manual should be provided to the site personnel to promote accurate data entry by them. These measures will result in reduced query generations and improved data integrity. It is recommended to establish and maintain a library of templates of standard CRF modules as they are time saving and cost-effective. This article is an attempt to describe the methods of CRF designing in clinical research and discusses the challenges encountered in this process.

  13. Basics of case report form designing in clinical research.

    Science.gov (United States)

    Bellary, Shantala; Krishnankutty, Binny; Latha, M S

    2014-10-01

    Case report form (CRF) is a specialized document in clinical research. It should be study protocol driven, robust in content and have material to collect the study specific data. Though paper CRFs are still used largely, use of electronic CRFs (eCRFS) are gaining popularity due to the advantages they offer such as improved data quality, online discrepancy management and faster database lock etc. Main objectives behind CRF development are preserving and maintaining quality and integrity of data. CRF design should be standardized to address the needs of all users such as investigator, site coordinator, study monitor, data entry personnel, medical coder and statistician. Data should be organized in a format that facilitates and simplifies data analysis. Collection of large amount of data will result in wasted resources in collecting and processing it and in many circumstances, will not be utilized for analysis. Apart from that, standard guidelines should be followed while designing the CRF. CRF completion manual should be provided to the site personnel to promote accurate data entry by them. These measures will result in reduced query generations and improved data integrity. It is recommended to establish and maintain a library of templates of standard CRF modules as they are time saving and cost-effective. This article is an attempt to describe the methods of CRF designing in clinical research and discusses the challenges encountered in this process.

  14. Recruiting US Chinese Elders Into Clinical Research for Dementia.

    Science.gov (United States)

    Li, Clara; Neugroschl, Judith; Umpierre, Mari; Martin, Jane; Huang, QiYing; Zeng, Xiaoyi; Cai, Dongming; Sano, Mary

    2016-01-01

    This study described and evaluated the rapid recruitment of elderly Chinese into clinical research at the Mount Sinai Alzheimer's Disease Research Center (MSADRC). Methods of publicizing the study included lectures to local senior centers/churches and publications in local Chinese newspapers. The amount of time and success of these methods were evaluated. A "go to them" model of evaluation was used to enable participants to complete the study visit at locations where they were comfortable. From January to December 2015, we recruited 98 participants aged 65 years or older who primarily speak Mandarin/Cantonese and reside in New York. The mean age and years of education was 73.93±6.34 and 12.79±4.58, respectively. The majority of participants were female (65.3%) and primarily Mandarin speaking (53.1%). Of all enrollees, 54.1% were recruited from community lectures, 29.6% through newspapers, 10.2% through word of mouth, and 6.1% from our clinical services. About 40.8% of participants underwent evaluations at the MSADRC, 44.9% at local senior centers/churches, and 14.3% at home. Given that the majority of our participants had low English proficiency, the use of bilingual recruiters probably allowed us to overcome the language barrier, facilitating recruitment. Our "go to them" model of evaluation is another important factor contributing to our successful recruitment.

  15. Clinical update on benefit versus risks of oral paracetamol alone or with codeine: still a good option?

    Science.gov (United States)

    Kress, Hans Georg; Untersteiner, Gerald

    2017-02-01

    After decades of worldwide use of paracetamol/acetaminophen as a popular and apparently safe prescription and over-the-counter medicine, the future role of this poorly understood analgesic has been seriously questioned by recent concerns about prenatal, cardiovascular (CV) and hepatic safety, and also about its analgesic efficacy. At the same time the usefulness of codeine in combination products has come under debate. Based on a PubMed database literature search on the terms efficacy, safety, paracetamol, acetaminophen, codeine and their combinations up to and including June 2016, this clinical update reviews the current evidence of the benefit and risks of oral paracetamol alone and with codeine for mild-to-moderate pain in adults, and compares the respective efficacy and safety profiles with those of nonsteroidal anti-inflammatory drugs (NSAIDs). Whereas there is a clear strong association of NSAID use and gastrointestinal (GI) and CV morbidity and mortality, evidence for paracetamol with and without codeine supports the recommended use even in most vulnerable individuals, such as the elderly, pregnant women, alcoholics, and compromised GI and CV patients. The controversies and widespread misconceptions about the complex hepatic metabolism and potential hepatotoxicity have been corrected by recent reviews, and paracetamol remains the first-line nonopioid analgesic in patients with liver diseases if notes of caution are applied. Due to its safety and tolerability profile paracetamol remained a first-line treatment in many international guidelines. Alone and with codeine it is a safe and effective option in adults, whilst NSAIDs are obviously less safe as alternatives, given the risk of potentially fatal GI and CV adverse effects.

  16. A good patient?

    DEFF Research Database (Denmark)

    Campbell, Catherine; Scott, Kerry; Skovdal, Morten

    2015-01-01

    , physical cleanliness, honesty, gratitude and lifestyle adaptations (taking pills correctly andcoming to the clinic when told). As healthcare workers may decide to punish patients who do not live up the‘good patient persona’, many patients seek to perform within the confines of the ‘good patient persona...

  17. A critique of statistical hypothesis testing in clinical research

    Directory of Open Access Journals (Sweden)

    Somik Raha

    2011-01-01

    Full Text Available Many have documented the difficulty of using the current paradigm of Randomized Controlled Trials (RCTs to test and validate the effectiveness of alternative medical systems such as Ayurveda. This paper critiques the applicability of RCTs for all clinical knowledge-seeking endeavors, of which Ayurveda research is a part. This is done by examining statistical hypothesis testing, the underlying foundation of RCTs, from a practical and philosophical perspective. In the philosophical critique, the two main worldviews of probability are that of the Bayesian and the frequentist. The frequentist worldview is a special case of the Bayesian worldview requiring the unrealistic assumptions of knowing nothing about the universe and believing that all observations are unrelated to each other. Many have claimed that the first belief is necessary for science, and this claim is debunked by comparing variations in learning with different prior beliefs. Moving beyond the Bayesian and frequentist worldviews, the notion of hypothesis testing itself is challenged on the grounds that a hypothesis is an unclear distinction, and assigning a probability on an unclear distinction is an exercise that does not lead to clarity of action. This critique is of the theory itself and not any particular application of statistical hypothesis testing. A decision-making frame is proposed as a way of both addressing this critique and transcending ideological debates on probability. An example of a Bayesian decision-making approach is shown as an alternative to statistical hypothesis testing, utilizing data from a past clinical trial that studied the effect of Aspirin on heart attacks in a sample population of doctors. As a big reason for the prevalence of RCTs in academia is legislation requiring it, the ethics of legislating the use of statistical methods for clinical research is also examined.

  18. Financial disclosure and clinical research: what is important to participants?

    Science.gov (United States)

    Hutchinson, Anastasia; Rubinfeld, Abe R

    2008-08-18

    To assess what participants in company-sponsored clinical trials wish to know about financial aspects of the study. Cross-sectional questionnaire administered to 324 participants in six clinical trials conducted at the Royal Melbourne Hospital in 1999-2000 and 2006 for non-acute conditions (asthma, chronic obstructive pulmonary disease, osteoporosis, rheumatoid arthritis, diabetes and influenza vaccine efficacy). Participants' desire for information on study funding, investigators' conflicts of interest, and use of accrued funds. 259 participants (80%) completed the survey. Participants wanted to be informed about the identity of the project sponsor (148 participants; 57%), whether the investigators owned shares in the company (105; 41%) or received travel grants (83; 32%), how much funding was accrued at study completion (88; 34%), how accrued funds were used (98; 38%), and who approved their use (91; 35%). After adjusting for year of survey and level of education, younger subjects (aged informed more often than older participants of who sponsored the project (odds ratio [OR], 2.35 [95% CI, 1.21-4.55]; P=0.012), whether the investigators owned shares in the company (OR, 2.41 [95% CI, 1.27-4.60]; P=0.007) and how much funding was available for other uses (OR, 1.79 [95% CI, 0.94-3.41]; P=0.078). While most participants indicated that they would take part in clinical research again regardless of whether they received financial information, providing information on the sponsor, the investigators' financial interest in the company, whether accrual of funds is expected, and how these funds will be spent should satisfy the interests of participants in company-sponsored clinical trials.

  19. PROTON RADIATION THERAPY: CLINICAL APPLICATION OPPORTUNITIES AND RESEARCH PROSPECTS

    Directory of Open Access Journals (Sweden)

    M. V. Zabelin

    2018-01-01

    Full Text Available This article is the review of literature concerning use of proton beam therapy in treatment of oncology. The staticized data on comparison of effi ciency of this method at an eye melanoma are lit. Advantages of proton therapy on the level of local control and depression of frequency of development of the radio induced cataract are refl ected in the provided data. In evident material the technology of preparation and carrying out radiation of an eye is shortly covered with a fascicle of protons. The experience of use of proton therapy of tumors of a skull base got for the last several decades, showed good results. Physical properties of a fascicle of protons allow to achieve the maximum dose conformality, having lowered, thereby, a radial load on the next crucial anatomical structures. The presented material on an oncopediatrics shows insuffi cient knowledge of scientists concerning advantage of a fascicle of protons over modern methods of photon radiation. There are only preliminary clinical results concerning generally of treatment of cranyopharyngiomas. At cancer therapy of a mammary gland, proton therapy showed the best local control of postoperative recurrent tumors, and also depression of a dose load on the contralateral party. The available results of the retrospective analysis of clinical data in the University medical center of Lome Linda, testify to advantages of proton therapy of the localized prostate cancer. The lack of a biochemical recurrence and a local tumoral progression within 5 years after radiation was shown. The data obtained from experience of use of proton radiation therapy with passively scattered fascicle for cancer therapy of a prostate at an early stage showed the admixed results in comparison with modern methods of radiation therapy with the modulated intensity. In treatment of non-small cell cancer of mild advantage of proton therapy aren’t absolutely proved yet. There are data on extreme toxicity of a combination

  20. Estándares de calidad en los ensayos clínicos: ISO 9001-Buena Práctica Clínica Quality standards in clinical tests. ISO 9001: Good Clinical Practice

    Directory of Open Access Journals (Sweden)

    Sandra Álvarez Guerra

    2005-12-01

    Full Text Available La calidad en los ensayos clínicos conducidos por los centros de investigación por contrato , constituye un factor de suma importancia. En la actualidad estas instituciones usan como estándar de calidad la Buena Práctica Clínica. Sin embargo, su combinación con la Norma ISO 9001:2000, estándar de calidad, internacionalmente utilizado, no se ha generalizado. Para demostrar la factibilidad que el uso conjunto de estas normas brindan a las organizaciones se decidió establecer reflexiones para demostrar cómo se complementan ambos estándares de calidad en la realización de ensayos clínicos. Para esto se revisó bibliografía actualizada en dichos temas. Se valoraron aspectos en común como: clientes, responsabilidad, tratamiento de datos generados, estadística, control de la calidad y documentos esenciales. Por medio de estos aspectos ambas normas tributan a la calidad del ensayo clínico, para una mejor protección al paciente, resultados confiables, satisfacción de los clientes, internos y externos, que garanticen la mejora continua, y establecer planes de contingencia y medidas preventivas. Se concluye que ambas normativas no están en contraposición y pueden ser utilizadas como vía capaz de garantizar excelencia en el servicio brindado.The quality of clinical tests conducted by the research centers on contract is a very important factor. Nowadays, these institutions use Good Clinical Practice as the quality standard. However, the combination of the latter with internationally used ISO 9001:2000 quality standard has not yet been generalized. In order to prove the feasibility that the joint use of these standards offers to organizations, it was decided to reflect on the way both quality standards complement each other in the performance of clinical tests. To this end, updated literature review was made. Common aspects such as clients, responsibility, treatment of data, statistics, quality control and essential documents were