Genes, molecules and patients—Emerging topics to guide clinical pain research

Science.gov (United States)

Sikandar, Shafaq; Patel, Ryan; Patel, Sital; Sikander, Sanam; Bennett, David L.H.; Dickenson, Anthony H.

2013-01-01

This review selectively explores some areas of pain research that, until recently, have been poorly understood. We have chosen four topics that relate to clinical pain and we discuss the underlying mechanisms and related pathophysiologies contributing to these pain states. A key issue in pain medicine involves crucial events and mediators that contribute to normal and abnormal pain signaling, but remain unseen without genetic, biomarker or imaging analysis. Here we consider how the altered genetic make-up of familial pains reveals the human importance of channels discovered by preclinical research, followed by the contribution of receptors as stimulus transducers in cold sensing and cold pain. Finally we review recent data on the neuro-immune interactions in chronic pain and the potential targets for treatment in cancer-induced bone pain. PMID:23500200

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.

Clinical code set engineering for reusing EHR data for research: A review.

Science.gov (United States)

Williams, Richard; Kontopantelis, Evangelos; Buchan, Iain; Peek, Niels

2017-06-01

The construction of reliable, reusable clinical code sets is essential when re-using Electronic Health Record (EHR) data for research. Yet code set definitions are rarely transparent and their sharing is almost non-existent. There is a lack of methodological standards for the management (construction, sharing, revision and reuse) of clinical code sets which needs to be addressed to ensure the reliability and credibility of studies which use code sets. To review methodological literature on the management of sets of clinical codes used in research on clinical databases and to provide a list of best practice recommendations for future studies and software tools. We performed an exhaustive search for methodological papers about clinical code set engineering for re-using EHR data in research. This was supplemented with papers identified by snowball sampling. In addition, a list of e-phenotyping systems was constructed by merging references from several systematic reviews on this topic, and the processes adopted by those systems for code set management was reviewed. Thirty methodological papers were reviewed. Common approaches included: creating an initial list of synonyms for the condition of interest (n=20); making use of the hierarchical nature of coding terminologies during searching (n=23); reviewing sets with clinician input (n=20); and reusing and updating an existing code set (n=20). Several open source software tools (n=3) were discovered. There is a need for software tools that enable users to easily and quickly create, revise, extend, review and share code sets and we provide a list of recommendations for their design and implementation. Research re-using EHR data could be improved through the further development, more widespread use and routine reporting of the methods by which clinical codes were selected. Copyright © 2017 The Author(s). Published by Elsevier Inc. All rights reserved.

Discovering disease associations by integrating electronic clinical data and medical literature.

Directory of Open Access Journals (Sweden)

Antony B Holmes

Full Text Available Electronic health record (EHR systems offer an exceptional opportunity for studying many diseases and their associated medical conditions within a population. The increasing number of clinical record entries that have become available electronically provides access to rich, large sets of patients' longitudinal medical information. By integrating and comparing relations found in the EHRs with those already reported in the literature, we are able to verify existing and to identify rare or novel associations. Of particular interest is the identification of rare disease co-morbidities, where the small numbers of diagnosed patients make robust statistical analysis difficult. Here, we introduce ADAMS, an Application for Discovering Disease Associations using Multiple Sources, which contains various statistical and language processing operations. We apply ADAMS to the New York-Presbyterian Hospital's EHR to combine the information from the relational diagnosis tables and textual discharge summaries with those from PubMed and Wikipedia in order to investigate the co-morbidities of the rare diseases Kaposi sarcoma, toxoplasmosis, and Kawasaki disease. In addition to finding well-known characteristics of diseases, ADAMS can identify rare or previously unreported associations. In particular, we report a statistically significant association between Kawasaki disease and diagnosis of autistic disorder.

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

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

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.

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

[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.

SU-F-T-330: Characterization of the Clinically Released ScandiDos Discover Diode Array for In-Vivo Dose Monitoring

Energy Technology Data Exchange (ETDEWEB)

Saenz, D; Gutierrez, A [University of Texas Health Science Center San Antonio, San Antonio, TX (United States)

2016-06-15

Purpose: The ScandiDos Discover has obtained FDA clearance and is now clinically released. We studied the essential attenuation and beam hardening components as well as tested the diode array’s ability to detect changes in absolute dose and MLC leaf positions. Methods: The ScandiDos Discover was mounted on the heads of an Elekta VersaHD and a Varian 23EX. Beam attenuation measurements were made at 10 cm depth for 6 MV and 18 MV beam energies. The PDD(10) was measured as a metric for the effect on beam quality. Next, a plan consisting of two orthogonal 10 × 10 cm2 fields was used to adjust the dose per fraction by scaling monitor units to test the absolute dose detection sensitivity of the Discover. A second plan (conformal arc) was then delivered several times independently on the Elekta VersaHD. Artificially introduced MLC position errors in the four central leaves were then added. The errors were incrementally increased from 1 mm to 4 mm and back across seven control points. Results: The absolute dose measured at 10 cm depth decreased by 1.2% and 0.7% for 6 MV and 18 MV beam with the Discover, respectively. Attenuation depended slightly on the field size but only changed the attenuation by 0.1% across 5 × 5 cm{sup 2} and 20 − 20 cm{sup 2} fields. The change in PDD(10) for a 10 − 10 cm{sup 2} field was +0.1% and +0.6% for 6 MV and 18 MV, respectively. Changes in monitor units from −5.0% to 5.0% were faithfully detected. Detected leaf errors were within 1.0 mm of intended errors. Conclusion: A novel in-vivo dosimeter monitoring the radiation beam during treatment was examined through its attenuation and beam hardening characteristics. The device tracked with changes in absolute dose as well as introduced leaf position deviations.

NIH Clinical Research Trials and You

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... 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 ...

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...

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.

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.

Discover POPSCIENCE on Researchers' Night

CERN Multimedia

The POPSCIENCE Team

2014-01-01

On Friday 26 September 2014, CERN will be celebrating European Researchers' Night at three venues in Geneva and St. Genis-Pouilly. Inspired by Andy Warhol, this year's theme is “Pop science is for everyone”.     Every year, on the last Friday of September, the European Researchers’ Night takes place in about 300 cities all over Europe, with funding from the EU, to promote research and highlight researchers in engaging and fun ways for the general public. Andy Warhol said, “Pop art is for everyone”. This year, “Pop science is for everyone” is the motto of the Researchers’ Night event organised by CERN and its partners*. The night will offer everyone the opportunity to learn about the latest discoveries in physics and cosmology through poetry, theatre and music. This will be in addition to the event's traditional activities for the general public. To attract new audiences,...

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

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

Scientists discover how deadly fungal microbes enter host cells

OpenAIRE

Whyte, Barry James

2010-01-01

A research team led by scientists at the Virginia Bioinformatics Institute at Virginia Tech has discovered a fundamental entry mechanism that allows dangerous fungal microbes to infect plants and cause disease.

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.

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.

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.

How to Conduct Clinical Qualitative Research on the Patient's Experience

Science.gov (United States)

Chenail, Ronald J.

2011-01-01

From a perspective of patient-centered healthcare, exploring patients' (a) preconceptions, (b) treatment experiences, (c) quality of life, (d) satisfaction, (e) illness understandings, and (f) design are all critical components in improving primary health care and research. Utilizing qualitative approaches to discover patients' experiences can…

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

Scientists discover planetary system similar to our own

CERN Multimedia

2003-01-01

'An international team of scientists has discovered a planet and star that may share the same relationship as Jupiter and our Sun, the closest comparison that researchers have found since they began their search for extra-solar planets nearly a decade ago' (1 page).

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.

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.

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...

The Paradox of Equipoise: The Principle That Drives and Limits Therapeutic Discoveries in Clinical Research

Science.gov (United States)

Djulbegovic, Benjamin

2009-01-01

Background Progress in clinical medicine relies on the willingness of patients to take part in experimental clinical trials, particularly randomized controlled trials (RCTs). Before agreeing to enroll in clinical trials, patients require guarantees that they will not knowingly be harmed and will have the best possible chances of receiving the most favorable treatments. This guarantee is provided by the acknowledgment of uncertainty (equipoise), which removes ethical dilemmas and makes it easier for patients to enroll in clinical trials. Methods Since the design of clinical trials is mostly affected by clinical equipoise, the “clinical equipoise hypothesis” has been postulated. If the uncertainty requirement holds, this means that investigators cannot predict what they are going to discover in any individual trial that they undertake. In some instances, new treatments will be superior to standard treatments, while in others, standard treatments will be superior to experimental treatments, and in still others, no difference will be detected between new and standard treatments. It is hypothesized that there must be a relationship between the overall pattern of treatment successes and the uncertainties that RCTs are designed to address. Results An analysis of published trials shows that the results cannot be predicted at the level of individual trials. However, the results also indicate that the overall pattern of discovery of treatment success across a series of trials is predictable and is consistent with clinical equipoise hypothesis. The analysis shows that we can discover no more than 25% to 50% of successful treatments when they are tested in RCTs. The analysis also indicates that this discovery rate is optimal in helping to preserve the clinical trial system; a high discovery rate (eg, a 90% to 100% probability of success) is neither feasible nor desirable since under these circumstances, neither the patient nor the researcher has an interest in

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

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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

Be a Partner in Clinical Research

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... 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 ...

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.

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.

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.
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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.

Metabolome analysis for discovering biomarkers of gastroenterological cancer.

Science.gov (United States)

Suzuki, Makoto; Nishiumi, Shin; Matsubara, Atsuki; Azuma, Takeshi; Yoshida, Masaru

2014-09-01

Improvements in analytical technologies have made it possible to rapidly determine the concentrations of thousands of metabolites in any biological sample, which has resulted in metabolome analysis being applied to various types of research, such as clinical, cell biology, and plant/food science studies. The metabolome represents all of the end products and by-products of the numerous complex metabolic pathways operating in a biological system. Thus, metabolome analysis allows one to survey the global changes in an organism's metabolic profile and gain a holistic understanding of the changes that occur in organisms during various biological processes, e.g., during disease development. In clinical metabolomic studies, there is a strong possibility that differences in the metabolic profiles of human specimens reflect disease-specific states. Recently, metabolome analysis of biofluids, e.g., blood, urine, or saliva, has been increasingly used for biomarker discovery and disease diagnosis. Mass spectrometry-based techniques have been extensively used for metabolome analysis because they exhibit high selectivity and sensitivity during the identification and quantification of metabolites. Here, we describe metabolome analysis using liquid chromatography-mass spectrometry, gas chromatography-mass spectrometry, and capillary electrophoresis-mass spectrometry. Furthermore, the findings of studies that attempted to discover biomarkers of gastroenterological cancer are also outlined. Finally, we discuss metabolome analysis-based disease diagnosis. Copyright © 2014 Elsevier B.V. All rights reserved.

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.

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.

Now that you want to take your HIV/AIDS vaccine/biological product research concept into the clinic: what are the "cGMP"?

Science.gov (United States)

Sheets, Rebecca L; Rangavajhula, Vijaya; Pullen, Jeffrey K; Butler, Chris; Mehra, Vijay; Shapiro, Stuart; Pensiero, Michael

2015-04-08

The Division of AIDS Vaccine Research Program funds the discovery and development of HIV/AIDS vaccine candidates. Basic researchers, having discovered a potential vaccine in the laboratory, next want to take that candidate into the clinic to test the concept in humans, to see if it translates. Many of them have heard of "cGMP" and know that they are supposed to make a "GMP product" to take into the clinic, but often they are not very familiar with what "cGMP" means and why these good practices are so important. As members of the Vaccine Translational Research Branch, we frequently get asked "can't we use the material we made in the lab in the clinic?" or "aren't Phase 1 studies exempt from cGMP?" Over the years, we have had many experiences where researchers or their selected contract manufacturing organizations have not applied an appropriate degree of compliance with cGMP suitable for the clinical phase of development. We share some of these experiences and the lessons learned, along with explaining the importance of cGMP, just what cGMP means, and what they can assure, in an effort to de-mystify this subject and facilitate the rapid and safe translational development of HIV vaccines. Published by Elsevier Ltd.

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...

Incidence of and sequels to medical problems discovered in medical students during study-related activities

NARCIS (Netherlands)

Pols, J; Boendermaker, PM; Muntinghe, H

2003-01-01

Purpose Students often act as subjects during practical and clinical skills training sessions. This routine seems to be quite acceptable for them but may present side-effects. Disorders, sometimes of a serious nature, have been discovered in medical students during clinical skills training. Because

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)

[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...

[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...

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

[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.

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.

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

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

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...

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...

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...

[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.

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...

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...

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...

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

Now That You Want to Take Your HIV/AIDS Vaccine/Biological Product Research Concept into the Clinic: What are “cGMP”?

Science.gov (United States)

Sheets, Rebecca L.; Rangavajhula, Vijaya; Pullen, Jeffrey K.; Butler, Chris; Mehra, Vijay; Shapiro, Stuart

2015-01-01

The Division of AIDS Vaccine Research Program funds the discovery and development of HIV/AIDS vaccine candidates. Basic researchers, having discovered a potential vaccine in the laboratory, next want to take that candidate into the clinic to test the concept in humans, to see if it translates. Many of them have heard of “cGMP” and know that they are supposed to make a “GMP product” to take into the clinic, but often they are not very familiar with what “cGMP” means and why these good practices are so important. As members of the Vaccine Translational Research Branch, we frequently get asked “can’t we use the material we made in the lab in the clinic?” or “aren’t Phase 1 studies exempt from cGMP?” Over the years, we have had many experiences where researchers or their selected contract manufacturing organizations have not applied an appropriate degree of compliance with cGMP suitable for the clinical phase of development. We share some of these experiences and the lessons learned, along with explaining the importance of cGMP, just what cGMP means, and what they can assure, in an effort to de-mystify this subject and facilitate the rapid and safe translational development of HIV vaccines. PMID:25698494

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.

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].

A model for integrating clinical care and basic science research, and pitfalls of performing complex research projects for addressing a clinical challenge.

Science.gov (United States)

Steck, R; Epari, D R; Schuetz, M A

2010-07-01

The collaboration of clinicians with basic science researchers is crucial for addressing clinically relevant research questions. In order to initiate such mutually beneficial relationships, we propose a model where early career clinicians spend a designated time embedded in established basic science research groups, in order to pursue a postgraduate qualification. During this time, clinicians become integral members of the research team, fostering long term relationships and opening up opportunities for continuing collaboration. However, for these collaborations to be successful there are pitfalls to be avoided. Limited time and funding can lead to attempts to answer clinical challenges with highly complex research projects characterised by a large number of "clinical" factors being introduced in the hope that the research outcomes will be more clinically relevant. As a result, the complexity of such studies and variability of its outcomes may lead to difficulties in drawing scientifically justified and clinically useful conclusions. Consequently, we stress that it is the basic science researcher and the clinician's obligation to be mindful of the limitations and challenges of such multi-factorial research projects. A systematic step-by-step approach to address clinical research questions with limited, but highly targeted and well defined research projects provides the solid foundation which may lead to the development of a longer term research program for addressing more challenging clinical problems. Ultimately, we believe that it is such models, encouraging the vital collaboration between clinicians and researchers for the work on targeted, well defined research projects, which will result in answers to the important clinical challenges of today. Copyright (c) 2010 Elsevier Ltd. All rights reserved.

US NSF: scientists discover planetary system similar to our own

CERN Multimedia

2003-01-01

An international team of scientists has discovered a planet and star that may share the same relationship as Jupiter and our Sun, the closest comparison that researchers have found since they began their search for extra-solar planets nearly a decade ago (1 page).

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.

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.

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

Discovering Hands - México

OpenAIRE

Salamanca Cárdenas, Daniela; Castelblanco Domínguez, Junio Andrés; Aguilar Ardila, Laura Andrea

2016-01-01

El modelo de Discovering Hands ha sido reconocido internacionalmente como un proyecto innovador que se ha expandido por diferentes países del mundo, como Austria, y se ha empezado a estudiar la propuesta en países como República Checa, India y Colombia. (Discovering Hands, 2016). Esto se debe a que no solo mejora el tratamiento de cáncer de mama, sino que también reduce los costos totales de tratamiento de la enfermedad y aumenta la fuerza laborar de los países donde esté presente. Al represe...

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...

Research concerning intestinal parasitosis in infant population discovered in two clinic laboratories from Oradea (Romania

Directory of Open Access Journals (Sweden)

Daniel-Dumitru PORTELECHI

2006-05-01

Full Text Available Considering the research made and the data offered by the specialists in parasitology from Oradea’s no.1 Polyclinic and Children’s Hospital, we have established that children from 1 to 18 years old have been found infected with 7 species of human parasites. Giardia lamblia, Blastocystis hominis, Ascaris lumbricoides, Oxyurus vermicularis, Trichurus trichiura, Hymenolepis nana, Hymenolepis diminuta.

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)

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.

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

Lipids in newly discovered subclinical and clinical hypothyroidism

Directory of Open Access Journals (Sweden)

Marinković Snežana

2016-01-01

Full Text Available There is a positive correlation between the levels of TSH and cholesterol levels, while levels between TSH levels triglicrerida negative correlation with the clinical and subclinical form of reduced thyroid function.

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...

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.

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.

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...

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.

[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.

Common definition for categories of clinical research: a prerequisite for a survey on regulatory requirements by the European Clinical Research Infrastructures Network (ECRIN)

LENUS (Irish Health Repository)

Kubiak, Christine

2009-10-16

Abstract Background Thorough knowledge of the regulatory requirements is a challenging prerequisite for conducting multinational clinical studies in Europe given their complexity and heterogeneity in regulation and perception across the EU member states. Methods In order to summarise the current situation 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 an agreement on a common classification was the initial step in the development of the survey. Results The ECRIN transnational working group on regulation, composed of experts in the field of clinical research from ten European countries, defined seven major categories of clinical research that seem relevant from both the regulatory and the scientific points of view, and correspond to congruent definitions in all countries: clinical trials on medicinal products; clinical trials on medical devices; other therapeutic trials (including surgery trials, transplantation trials, transfusion trials, trials 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 was essential to develop a survey focused on protocol submission to ethics committees and competent authorities, procedures for amendments, requirements for sponsor and insurance, and adverse event reporting following five main phases: drafting, consensus, data collection, validation, and finalising. Conclusion The list of clinical research categories as used for the survey could serve as a contribution to the, much needed, task of harmonisation and simplification of the

Common definition for categories of clinical research: a prerequisite for a survey on regulatory requirements by the European Clinical Research Infrastructures Network (ECRIN

Directory of Open Access Journals (Sweden)

Sanz Nuria

2009-10-01

Full Text Available Abstract Background Thorough knowledge of the regulatory requirements is a challenging prerequisite for conducting multinational clinical studies in Europe given their complexity and heterogeneity in regulation and perception across the EU member states. Methods In order to summarise the current situation 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 an agreement on a common classification was the initial step in the development of the survey. Results The ECRIN transnational working group on regulation, composed of experts in the field of clinical research from ten European countries, defined seven major categories of clinical research that seem relevant from both the regulatory and the scientific points of view, and correspond to congruent definitions in all countries: clinical trials on medicinal products; clinical trials on medical devices; other therapeutic trials (including surgery trials, transplantation trials, transfusion trials, trials 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 was essential to develop a survey focused on protocol submission to ethics committees and competent authorities, procedures for amendments, requirements for sponsor and insurance, and adverse event reporting following five main phases: drafting, consensus, data collection, validation, and finalising. Conclusion The list of clinical research categories as used for the survey could serve as a contribution to the, much needed, task of harmonisation and

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.

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.

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...

REVIEW: Discovering Statistics Using SPSS for Windows ANDY FIELD (2000)

OpenAIRE

SHARMA, Reviewed By Ashok

2015-01-01

The book "Discovering Statistics Using SPSS for Windows" is exactly that! Since it calculates amazingly fast, in the recent years, the computer has become the most useful and helpful tool for the researchers in almost every field of knowledge - be it open and distance education, psychology, sociology, management or else.

Pancreatic sarcoidosis discovered during Whipple procedure.

Science.gov (United States)

Cook, Jonathan; Spees, Tanner; Telefus, Phillip; Ranaudo, Jeffrey M; Carryl, Stephen; Xiao, Philip

2013-04-04

Pancreatic sarcoidosis is a rare variant of systemic sarcoidosis, with cases described in literature as recently as January 2010. We present here a case of pancreatic involvement with non-caseating granulomas discovered on laparotomy in a patient with a preoperative diagnosis of pancreatic carcinoma. Computer tomography scan without contrast revealed a well-marginated smooth-shaped tumor in the head of the pancreas morphologically consistent with malignancy. During Whipple procedure, the mass was found to be a large lymph node that contained numerous non-caseating granulomas. Radiologically and clinically, non-caseating granulomas of the pancreas are often misdiagnosed as malignant tumor. Special attention given to this differential diagnosis by surgeons, pathologists and clinicians can avoid misdiagnosis and unnecessary treatment. Published by Oxford University Press and JSCR Publishing Ltd. All rights reserved. © The Author 2013.

Potential Applications of the National Institute of Mental Health's Research Domain Criteria (RDoC) to Clinical Psychiatric Practice: How RDoC Might Be Used in Assessment, Diagnostic Processes, Case Formulation, Treatment Planning, and Clinical Notes.

Science.gov (United States)

Yager, Joel; Feinstein, Robert E

2017-04-01

Offering a new framework for understanding and studying basic dimensions of normal and abnormal human functioning and mental disorders, the National Institute of Mental Health (NIMH) has initiated the Research Domain Criteria (RDoC) project in which a series of higher order domains, representing major systems of emotion, cognition, motivation, and social behavior, and their constituent operationally defined constructs serve as organizing templates for further research and inquiry, eg, to discover validated biomarkers and endophenotypes. Cutting across traditional DSM diagnoses, the domains are defined as Negative Valence Systems, Positive Valence Systems, Cognitive Systems, Systems for Social Processes, and Arousal/Regulatory Systems. To inform educators, trainees, and practitioners about RDoC, alert them to potential practical applications, and encourage their broad exploration in clinical settings, this article reviews the RDoC domains and their subsystem constructs with regard to potential current clinical considerations and applications. We describe ways in which the RDoC domains and constructs offer transdiagnostic frameworks for complementing traditional practice; suggest clinical questions to help elucidate salient information; and, translating RDoC domains and constructs headings into clinically friendly language, offer a template for the psychiatric review of systems that can serve in clinical notes. © Copyright 2017 Physicians Postgraduate Press, Inc.

Did the ancient egyptians discover Algol?

Science.gov (United States)

Jetsu, L.; Porceddu, S.; Porceddu, S.; Lyytinen, J.; Kajatkari, P.; Markkanen, T.; Toivari-Viitala, J.

2013-02-01

Fabritius discovered the first variable star, Mira, in 1596. Holwarda determined the 11 months period of Mira in 1638. Montanari discovered the next variable star, Algol, in 1669. Its period, 2.867 days, was determined by Goodricke (178). Algol was associated with demon-like creatures, "Gorgon" in ancient Greek and "ghoul" in ancient Arab mythology. This indicates that its variability was discovered much before 1669 (Wilk 1996), but this mythological evidence is ambiguous (Davis 1975). For thousands of years, the Ancient Egyptian Scribes (AES) observed stars for timekeeping in a region, where there are nearly 300 clear nights a year. We discovered a significant periodicity of 2.850 days in their calendar for lucky and unlucky days dated to 1224 BC, "the Cairo Calendar". Several astrophysical and astronomical tests supported our conclusion that this was the period of Algol three millennia ago. The "ghoulish habits" of Algol could explain this 0.017 days period increase (Battersby 2012).

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

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.

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.)

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...

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.

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.

Research on Methods for Discovering and Selecting Cloud Infrastructure Services Based on Feature Modeling

Directory of Open Access Journals (Sweden)

Huamin Zhu

2016-01-01

Full Text Available Nowadays more and more cloud infrastructure service providers are providing large numbers of service instances which are a combination of diversified resources, such as computing, storage, and network. However, for cloud infrastructure services, the lack of a description standard and the inadequate research of systematic discovery and selection methods have exposed difficulties in discovering and choosing services for users. First, considering the highly configurable properties of a cloud infrastructure service, the feature model method is used to describe such a service. Second, based on the description of the cloud infrastructure service, a systematic discovery and selection method for cloud infrastructure services are proposed. The automatic analysis techniques of the feature model are introduced to verify the model’s validity and to perform the matching of the service and demand models. Finally, we determine the critical decision metrics and their corresponding measurement methods for cloud infrastructure services, where the subjective and objective weighting results are combined to determine the weights of the decision metrics. The best matching instances from various providers are then ranked by their comprehensive evaluations. Experimental results show that the proposed methods can effectively improve the accuracy and efficiency of cloud infrastructure service discovery and selection.

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.

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

Needs assessment for collaborative network in pediatric clinical research and education.

Science.gov (United States)

Ishiguro, Akira; Sasaki, Hatoko; Yahagi, Naohisa; Kato, Hitoshi; Kure, Shigeo; Mori, Rintaro

2017-01-01

A collaborative network for pediatric research has not been fully established in Japan. To identify the network infrastructure, we conducted a survey on the support and education for clinical research currently available in children's hospitals. In November 2014, a 27-question survey was distributed to 31 hospitals belonging to the Japanese Association of Children's Hospitals and Related Institutions (JACHRI) to assess clinical research support, research education, research achievements, and their expectations. All the hospitals responded to the survey. Overall, 74.2% of hospitals had clinical research support divisions. Although all hospitals had ethics committees, manager, intellectual property management unit, biostatistician, and English-language editor. Seven hospitals had education programs for clinical research. The number of seminars and workshops for clinical research had significant correlations with the number of physicians (r = 0.927), pediatricians (r = 0.922), and clinical trial management physicians (r = 0.962). There was a significant difference in the number of clinical trials initiated by physicians between hospitals with research education programs and those without (P leader to establish a collaborative network for clinical research. Important factors for creating a collaborative system for pediatric research in Japan were identified. Human resources to support clinical research are a key factor to improve clinical research education and research achievements. © 2016 Japan Pediatric Society.

A novel approach to generating CER hypotheses based on mining clinical data.

Science.gov (United States)

Zhang, Shuo; Li, Lin; Yu, Yiqin; Sun, Xingzhi; Xu, Linhao; Zhao, Wei; Teng, Xiaofei; Pan, Yue

2013-01-01

Comparative effectiveness research (CER) is a scientific method of investigating the effectiveness of alternative intervention methods. In a CER study, clinical researchers typically start with a CER hypothesis, and aim to evaluate it by applying a series of medical statistical methods. Traditionally, the CER hypotheses are defined manually by clinical researchers. This makes the task of hypothesis generation very time-consuming and the quality of hypothesis heavily dependent on the researchers' skills. Recently, with more electronic medical data being collected, it is highly promising to apply the computerized method for discovering CER hypotheses from clinical data sets. In this poster, we proposes a novel approach to automatically generating CER hypotheses based on mining clinical data, and presents a case study showing that the approach can facilitate clinical researchers to identify potentially valuable hypotheses and eventually define high quality CER studies.

Discovering the Solar System

Science.gov (United States)

Jones, Barrie W.

1999-04-01

Discovering the Solar System Barrie W. Jones The Open University, Milton Keynes, UK Discovering the Solar System is a comprehensive, up-to-date account of the Solar System and of the ways in which the various bodies have been investigated and modelled. The approach is thematic, with sequences of chapters on the interiors of planetary bodies, on their surfaces, and on their atmospheres. Within each sequence there is a chapter on general principles and processes followed by one or two chapters on specific bodies. There is also an introductory chapter, a chapter on the origin of the Solar System, and a chapter on asteroids, comets and meteorites. Liberally illustrated with diagrams, black and white photographs and colour plates, Discovering the Solar System also features: * tables of essential data * question and answers within the text * end of section review questions with answers and comments Discovering the Solar System is essential reading for all undergraduate students for whom astronomy or planetary science are components of their degrees, and for those at a more advanced level approaching the subject for the first time. It will also be of great interest to non-specialists with a keen interest in astronomy. A small amount of scientific knowledge is assumed plus familiarity with basic algebra and graphs. There is no calculus. Praise for this book includes: ".certainly qualifies as an authoritative text. The author clearly has an encyclopedic knowledge of the subject." Meteorics and Planetary Science ".liberally doused with relevant graphs, tables, and black and white figures of good quality." EOS, Transactions of the American Geophysical Union ".one of the best books on the Solar System I have seen. The general accuracy and quality of the content is excellent." Journal of the British Astronomical Association

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.

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...

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

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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.

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.

2015 USAFA Research Report: Discover Falcon Innovation

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2015-01-01

geotechnical, structures, environmental and construction. First, in the geotechnical division, Lt Col Chris Senseney is researching “Computational Modeling of...communicate. “It’s a new area for us,” said Lt Col Chris McClernon, director of the center. “We started it last summer, because we know communications...Sales de Souza, Major Mark Braun, 1st Lt Melanie Ortiz, 1st Lt Seth Rodgers and Cadet 1st Class Jordan Higgins are working on a research project

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

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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...

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...

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.

A Network Biology Approach to Discover the Molecular Biomarker Associated with Hepatocellular Carcinoma

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Liwei Zhuang

2014-01-01

Full Text Available In recent years, high throughput technologies such as microarray platform have provided a new avenue for hepatocellular carcinoma (HCC investigation. Traditionally, gene sets enrichment analysis of survival related genes is commonly used to reveal the underlying functional mechanisms. However, this approach usually produces too many candidate genes and cannot discover detailed signaling transduction cascades, which greatly limits their clinical application such as biomarker development. In this study, we have proposed a network biology approach to discover novel biomarkers from multidimensional omics data. This approach effectively combines clinical survival data with topological characteristics of human protein interaction networks and patients expression profiling data. It can produce novel network based biomarkers together with biological understanding of molecular mechanism. We have analyzed eighty HCC expression profiling arrays and identified that extracellular matrix and programmed cell death are the main themes related to HCC progression. Compared with traditional enrichment analysis, this approach can provide concrete and testable hypothesis on functional mechanism. Furthermore, the identified subnetworks can potentially be used as suitable targets for therapeutic intervention in HCC.

Comparative audit of clinical research in pediatric neurology.

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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.

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

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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...

Assessing Clinical Research Capacity in Vietnam: A Framework for Strengthening Capability for Clinical Trials in Developing Countries.

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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.

Ethics in clinical research: the Indian perspective.

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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.

Five-year review of an international clinical research-training program

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Suemoto, Claudia Kimie; Ismail, Sherine; Corrêa, Paulo César Rodrigues Pinto; Khawaja, Faiza; Jerves, Teodoro; Pesantez, Laura; Germani, Ana Claudia Camargo Gonçalves; Zaina, Fabio; dos Santos, Augusto Cesar Soares; de Oliveira Ferreira, Ricardo Jorge; Singh, Priyamvada; Paulo, Judy Vicente; Matsubayashi, Suely Reiko; Vidor, Liliane Pinto; Andretta, Guilherme; Tomás, Rita; Illigens, Ben MW; Fregni, Felipe

2015-01-01

The exponential increase in clinical research has profoundly changed medical sciences. Evidence that has accumulated in the past three decades from clinical trials has led to the proposal that clinical care should not be based solely on clinical expertise and patient values, and should integrate robust data from systematic research. As a consequence, clinical research has become more complex and methods have become more rigorous, and evidence is usually not easily translated into clinical practice. Therefore, the instruction of clinical research methods for scientists and clinicians must adapt to this new reality. To address this challenge, a global distance-learning clinical research-training program was developed, based on collaborative learning, the pedagogical goal of which was to develop critical thinking skills in clinical research. We describe and analyze the challenges and possible solutions of this course after 5 years of experience (2008–2012) with this program. Through evaluation by students and faculty, we identified and reviewed the following challenges of our program: 1) student engagement and motivation, 2) impact of heterogeneous audience on learning, 3) learning in large groups, 4) enhancing group learning, 5) enhancing social presence, 6) dropouts, 7) quality control, and 8) course management. We discuss these issues and potential alternatives with regard to our research and background. PMID:25878518

Five-year review of an international clinical research-training program.

Science.gov (United States)

Suemoto, Claudia Kimie; Ismail, Sherine; Corrêa, Paulo César Rodrigues Pinto; Khawaja, Faiza; Jerves, Teodoro; Pesantez, Laura; Germani, Ana Claudia Camargo Gonçalves; Zaina, Fabio; Dos Santos, Augusto Cesar Soares; de Oliveira Ferreira, Ricardo Jorge; Singh, Priyamvada; Paulo, Judy Vicente; Matsubayashi, Suely Reiko; Vidor, Liliane Pinto; Andretta, Guilherme; Tomás, Rita; Illigens, Ben Mw; Fregni, Felipe

2015-01-01

The exponential increase in clinical research has profoundly changed medical sciences. Evidence that has accumulated in the past three decades from clinical trials has led to the proposal that clinical care should not be based solely on clinical expertise and patient values, and should integrate robust data from systematic research. As a consequence, clinical research has become more complex and methods have become more rigorous, and evidence is usually not easily translated into clinical practice. Therefore, the instruction of clinical research methods for scientists and clinicians must adapt to this new reality. To address this challenge, a global distance-learning clinical research-training program was developed, based on collaborative learning, the pedagogical goal of which was to develop critical thinking skills in clinical research. We describe and analyze the challenges and possible solutions of this course after 5 years of experience (2008-2012) with this program. Through evaluation by students and faculty, we identified and reviewed the following challenges of our program: 1) student engagement and motivation, 2) impact of heterogeneous audience on learning, 3) learning in large groups, 4) enhancing group learning, 5) enhancing social presence, 6) dropouts, 7) quality control, and 8) course management. We discuss these issues and potential alternatives with regard to our research and background.

Examining Pre-K Professional Development Programs: Discovering the Road to Exceptional Instructional Practices

Science.gov (United States)

Williams, Sheila D.

2016-01-01

The purpose of this qualitative research study was to discover and interpret the experiences of pre-k teachers in an urban school district located in a Northeastern region of the United States. Using a basic qualitative research design, fifteen participants were recruited by a purposeful sampling method to be interviewed after the implementation…

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.

The development of a scale to discover outpatients' perceptions of the relative desirability of different elements of doctors' communication behaviours.

Science.gov (United States)

Leckie, Jackie; Bull, Ray; Vrij, Aldert

2006-12-01

The objective of the study was to discover which aspects of doctor communication behaviours are more or less desirable to patients who are attending medical outpatients clinics. Two hundred and twenty patients took part in the study, which was undertaken in four phases. In phase one, patients completed a 10-item questionnaire where they indicated, by means of a five-point scale, their preferences for doctor communication behaviours. In phases two and three patients qualitatively expressed the meaning that they ascribed to terminology that is used by some researchers to define doctor communication behaviours. In the final phase of the study a 12-item questionnaire was developed by integrating the phase one questionnaire and patients' report from phases two and three. Patients indicated, by means of a five-point scale, their preferences for different communication behaviours that might be used by doctors. Patient's preferences were ranked in terms of the most to the least preferred behaviours. The findings suggest that patients most prefer consultations where doctors give information spontaneously and display affective behaviours. They least preferred consultations where medical matters are discussed and where information is not forthcoming. Furthermore, the finding suggests that the use of blanket terms by researches in defining doctor communication can lead to differences in interpretation by patients. The methods developed in the study appear to provide a useful tool to discover patients' desires in terms of doctor communication. The rank scale developed in the study could prove useful to medical practice. It could, for example, provide a straightforward method whereby doctors could readily access researcher's recommendations about communication. Furthermore, the scale could be used in various healthcare settings in order to discover if different patient groups vary in terms of the doctor communication they desire.

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.

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

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.

Clinical trials: bringing research to the bedside.

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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.

A proposed clinical research support career pathway for noninvestigators.

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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.

Discovering, Indexing and Interlinking Information Resources.

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Celli, Fabrizio; Keizer, Johannes; Jaques, Yves; Konstantopoulos, Stasinos; Vudragović, Dušan

2015-01-01

The social media revolution is having a dramatic effect on the world of scientific publication. Scientists now publish their research interests, theories and outcomes across numerous channels, including personal blogs and other thematic web spaces where ideas, activities and partial results are discussed. Accordingly, information systems that facilitate access to scientific literature must learn to cope with this valuable and varied data, evolving to make this research easily discoverable and available to end users. In this paper we describe the incremental process of discovering web resources in the domain of agricultural science and technology. Making use of Linked Open Data methodologies, we interlink a wide array of custom-crawled resources with the AGRIS bibliographic database in order to enrich the user experience of the AGRIS website. We also discuss the SemaGrow Stack, a query federation and data integration infrastructure used to estimate the semantic distance between crawled web resources and AGRIS.

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.

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

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)

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.

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.

Discovering and Promoting Commodity Health Attributes: Programs and Issues

OpenAIRE

Carman, Hoy F.

2007-01-01

There is a growing consumer segment demanding healthy foods and diets, health and nutrition messages can expand food demand, and governments in the U.S. and EU, faced with increasing obesity and associated health outcomes, want consumers to have reliable information to choose healthy diets. California commodity organizations, charged with expanding the demand for almonds, avocados, strawberries and walnuts, are funding health and nutrition research as a means to discover a unique selling prop...

Screening individual hybridomas by microengraving to discover monoclonal antibodies

Science.gov (United States)

Ogunniyi, Adebola O; Story, Craig M; Papa, Eliseo; Guillen, Eduardo; Love, J Christopher

2014-01-01

The demand for monoclonal antibodies (mAbs) in biomedical research is significant, but the current methodologies used to discover them are both lengthy and costly. Consequently, the diversity of antibodies available for any particular antigen remains limited. Microengraving is a soft lithographic technique that provides a rapid and efficient alternative for discovering new mAbs. This protocol describes how to use microengraving to screen mouse hybridomas to establish new cell lines producing unique mAbs. Single cells from a polyclonal population are isolated into an array of microscale wells (~105 cells per screen). The array is then used to print a protein microarray, where each element contains the antibodies captured from individual wells. The antibodies on the microarray are screened with antigens of interest, and mapped to the corresponding cells, which are then recovered from their microwells by micromanipulation. Screening and retrieval require approximately 1–3 d (9–12 d including the steps for preparing arrays of microwells). PMID:19528952

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.

Discovering workflow nets using integer linear programming

NARCIS (Netherlands)

van Zelst, S.J.; van Dongen, B.F.; van der Aalst, W.M.P.; Verbeek, H.M.W.

Process mining is concerned with the analysis, understanding and improvement of business processes. Process discovery, i.e. discovering a process model based on an event log, is considered the most challenging process mining task. State-of-the-art process discovery algorithms only discover local

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...

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.

Supporting open access to clinical trial data for researchers: The Duke Clinical Research Institute-Bristol-Myers Squibb Supporting Open Access to Researchers Initiative.

Science.gov (United States)

Pencina, Michael J; Louzao, Darcy M; McCourt, Brian J; Adams, Monique R; Tayyabkhan, Rehbar H; Ronco, Peter; Peterson, Eric D

2016-02-01

There are growing calls for sponsors to increase transparency by providing access to clinical trial data. In response, Bristol-Myers Squibb and the Duke Clinical Research Institute have collaborated on a new initiative, Supporting Open Access to Researchers. The aim is to facilitate open sharing of Bristol-Myers Squibb trial data with interested researchers. Key features of the Supporting Open Access to Researchers data sharing model include an independent review committee that ensures expert consideration of each proposal, stringent data deidentification/anonymization and protection of patient privacy, requirement of prespecified statistical analysis plans, and independent review of manuscripts before submission for publication. We believe that these approaches will promote open science by allowing investigators to verify trial results as well as to pursue interesting secondary uses of trial data without compromising scientific integrity. Copyright © 2015 Elsevier Inc. All rights reserved.

Canary: An NLP Platform for Clinicians and Researchers.

Science.gov (United States)

Malmasi, Shervin; Sandor, Nicolae L; Hosomura, Naoshi; Goldberg, Matt; Skentzos, Stephen; Turchin, Alexander

2017-05-03

Information Extraction methods can help discover critical knowledge buried in the vast repositories of unstructured clinical data. However, these methods are underutilized in clinical research, potentially due to the absence of free software geared towards clinicians with little technical expertise. The skills required for developing/using such software constitute a major barrier for medical researchers wishing to employ these methods. To address this, we have developed Canary, a free and open-source solution designed for users without natural language processing (NLP) or software engineering experience. It was designed to be fast and work out of the box via a user-friendly graphical interface.

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.

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.

Commentary: discovering a different model of medical student education.

Science.gov (United States)

Watson, Robert T

2012-12-01

Traditional medical schools in modern academic health centers make discoveries, create new knowledge and technology, provide innovative care to the sickest patients, and educate future academic and practicing physicians. Unfortunately, the growth of the research and clinical care missions has sometimes resulted in a loss of emphasis on the general professional education of medical students. The author concludes that it may not be practical for many established medical schools to functionally return to the reason they were created: for the education of medical students.He had the opportunity to discover a different model of medical student education at the first new MD-granting medical school created in the United States in 25 years (in 2000), the Florida State University College of Medicine. He was initially skeptical about how its distributed regional campuses model, using practicing primary care physicians to help medical students learn in mainly ambulatory settings, could be effective. But his experience as a faculty member at the school convinced him that the model works very well.He proposes a better alignment of form and function for many established medical schools and an extension of the regional community-based model to the formation of community-based primary care graduate medical education programs determined by physician workforce needs and available resources.

Discovering Diabetes Complications: an Ontology Based Model.

Science.gov (United States)

Daghistani, Tahani; Shammari, Riyad Al; Razzak, Muhammad Imran

2015-12-01

Diabetes is a serious disease that spread in the world dramatically. The diabetes patient has an average of risk to experience complications. Take advantage of recorded information to build ontology as information technology solution will help to predict patients who have average of risk level with certain complication. It is helpful to search and present patient's history regarding different risk factors. Discovering diabetes complications could be useful to prevent or delay the complications. We designed ontology based model, using adult diabetes patients' data, to discover the rules of diabetes with its complications in disease to disease relationship. Various rules between different risk factors of diabetes Patients and certain complications generated. Furthermore, new complications (diseases) might be discovered as new finding of this study, discovering diabetes complications could be useful to prevent or delay the complications. The system can identify the patients who are suffering from certain risk factors such as high body mass index (obesity) and starting controlling and maintaining plan.

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

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…

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.

Building a bridge for nursing education and clinical care in Taiwan--using action research and Confucian tradition to close the gap.

Science.gov (United States)

Yang, Wan-Ping; Chao, Co-Shi Chantal; Lai, Wei-Shu; Chen, Ching-Huey; Shih, Ya Lan; Chiu, Ge-Lin

2013-03-01

Nursing workplaces in Taiwan are unable to retain talent. An examination of this problem has revealed that the causes of this phenomenon are that nursing education fails to cultivate the skills that meet workplace requirements and that there are gap between nursing education and clinical practice. This paper is an action research that aims is to design educational programs that can close the gap between nursing education and clinical practice in Taiwan. In this action research project, 4 action cycles were used to design educational programs including concept mapping and focused discussion strategies. Participants were invited to join the research in three teaching hospitals and one university. Two groups of participants, student nurses (SN) and nursing staff personnel (NS), were sampled and invited to participate in the research. Participant observation, focus groups, and qualitative interviews were used to collect data. Qualitative data were not only profiled by content analysis, but they were also compared continuously between the two groups as well as between the 4 cycles. The qualitative data collected for the 135 participants were analysed. The themes of an effective nursing program were summarized. Many fundamental values of traditional Chinese education have gradually faded due to the Westernization of education. In this study, we discovered that Western educational models may play a critical role in improving traditionally taught nursing education programs. Copyright © 2012 Elsevier Ltd. All rights reserved.

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 ...

Building research capacity: through a hospital-based clinical school of nursing.

Science.gov (United States)

Lee, Geraldine; Metcalf, Suzanne

2009-04-01

For clinical nurses and nursing academics wishing to participate in research, there are several logistical issues such as high workloads, lack of time and poor research skills and knowledge that can impede research being undertaken. To address these issues, La Trobe University in partnership with one of Melbourne's acute care hospitals developed a clinical school with the aim of delivering postgraduate courses and undertaking collaborative clinically focused nursing research. Clinical issues were identified jointly between university academics and clinical nursing staff. Research questions were developed to examine these issues with the clinical school staff facilitating the research process. Research has been undertaken in many specialty areas including emergency, cardiac and intensive care nursing and diabetes. The success of this collaboration is evident with many studies being undertaken and consequently dissemination of research findings published (with clinicians being the primary author on many papers), presentations at national and international conferences by clinical staff as well as an increased enrollment into masters and doctoral programmes. The presence of the clinical school at the hospital has been beneficial both to clinicians and nurse academics and resulted in developing a positive research environment. More importantly, the research has led to changes in patient care and enabled clinicians to gain research experience and further academic qualifications. The other benefit is that nurse academics have strengthened their working relationship with clinicians and ensured visible research outputs were achieved.

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...

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.

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.

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

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

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.

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

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.

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...

Discovering a Reliable Heat-Shock Factor-1 Inhibitor to Treat Human Cancers: Potential Opportunity for Phytochemists

Directory of Open Access Journals (Sweden)

Murugesan Velayutham

2018-04-01

Full Text Available Heat-shock factor-1 (HSF-1 is an important transcription factor that regulates pathogenesis of many human diseases through its extensive transcriptional regulation. Especially, it shows pleiotropic effects in human cancer, and hence it has recently received increased attention of cancer researchers. After myriad investigations on HSF-1, the field has advanced to the phase where there is consensus that finding a potent and selective pharmacological inhibitor for this transcription factor will be a major break-through in the treatment of various human cancers. Presently, all reported inhibitors have their limitations, made evident at different stages of clinical trials. This brief account summarizes the advances with tested natural products as HSF-1 inhibitors and highlights the necessity of phytochemistry in this endeavor of discovering a potent pharmacological HSF-1 inhibitor.

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...

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)

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.

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.

Expanding clinical research capacity through a community of practice (CoPER).

Science.gov (United States)

Short, Alison; Jackson, Wanda; Nugus, Peter

2010-01-01

The proposed CoPER project (Community of Practice for Engaging in Research) responds to a need for increased research capacity in a clinical setting. We put forward an argument and a design for a prospective action research project to extend research capacity via an integrated academic and practitioner community of practice in an Emergency Department (ED). This paper explores the research needs of clinicians, articulates the concept of community of practice in light of these needs, and outlines the rationale for considering communities of practice as a potential contributor to building research capacity in a clinical setting. A potential methodology is suggested to test the linkage between research needs, the concept of a community of practice model in a clinical setting, and the contribution of such a model to building research capacity in a clinical setting via the CoPER framework. Combined data from this proposed mixed method action research (survey, focus groups, interviews, observation) are expected to enable the production of a set of facilitators and enablers with a view to building a community of research practice which make the case study transferable to other clinical and non-clinical work settings.

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

Strategic Sustainability Performance Plan. Discovering Sustainable Solutions to Power and Secure America’s Future

Energy Technology Data Exchange (ETDEWEB)

None, None

2010-09-01

Sustainability is fundamental to the Department of Energy’s research mission and operations as reflected in the Department’s Strategic Plan. Our overarching mission is to discover the solutions to power and secure America’s future.

[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.

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.

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

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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

The potential of the ILC for discovering new particles

Energy Technology Data Exchange (ETDEWEB)

Fujii, Keisuke [High Energy Accelerator Research Organization (KEK), Ibaraki (Japan); Grojean, Christophe [DESY, Hamburg (Germany); Humboldt-Univ., Berlin (Germany). Inst. fuer Physik; ICREA, Barcelona (Spain); Peskin, Michael E. [Stanford Univ., Menlo Park, CA (United States). SLAC; Collaboration: LCC Physics Working Group; and others

2017-02-15

This paper addresses the question of whether the International Linear Collider has the capability of discovering new particles that have not already been discovered at the CERN Large Hadron Collider. We summarize the various paths to discovery offered by the ILC, and discuss them in the context of three different scenarios: 1. LHC does not discover any new particles, 2. LHC discovers some new low mass states and 3. LHC discovers new heavy particles. We will show that in each case, ILC plays a critical role in discovery of new phenomena and in pushing forward the frontiers of high-energy physics as well as our understanding of the universe in a manner which is highly complementary to that of LHC. For the busy reader, a two-page executive summary is provided at the beginning of the document.

The potential of the ILC for discovering new particles

International Nuclear Information System (INIS)

Fujii, Keisuke; Grojean, Christophe; Peskin, Michael E.

2017-02-01

This paper addresses the question of whether the International Linear Collider has the capability of discovering new particles that have not already been discovered at the CERN Large Hadron Collider. We summarize the various paths to discovery offered by the ILC, and discuss them in the context of three different scenarios: 1. LHC does not discover any new particles, 2. LHC discovers some new low mass states and 3. LHC discovers new heavy particles. We will show that in each case, ILC plays a critical role in discovery of new phenomena and in pushing forward the frontiers of high-energy physics as well as our understanding of the universe in a manner which is highly complementary to that of LHC. For the busy reader, a two-page executive summary is provided at the beginning of the document.

Heart Failure: From Research to Clinical Practice.

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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.

Legitimating Clinical Research in the Study of Organizational Culture.

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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…

Feasibility of Conducting Autism Biomarker Research in the Clinical Setting.

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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.

Ensuring rigour and trustworthiness of qualitative research in clinical pharmacy.

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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.

Blockchain technology for improving clinical research quality.

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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.

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

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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.

The European Multicentre Bronchiectasis Audit and Research Collaboration (EMBARC): experiences from a successful ERS Clinical Research Collaboration.

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Chalmers, James D; Crichton, Megan; Goeminne, Pieter C; Loebinger, Michael R; Haworth, Charles; Almagro, Marta; Vendrell, Montse; De Soyza, Anthony; Dhar, Raja; Morgan, Lucy; Blasi, Francesco; Aliberti, Stefano; Boyd, Jeanette; Polverino, Eva

2017-09-01

In contrast to airway diseases like chronic obstructive pulmonary disease or asthma, and rare diseases such as cystic fibrosis, there has been little research and few clinical trials in bronchiectasis. Guidelines are primarily based on expert opinion and treatment is challenging because of the heterogeneous nature of the disease. In an effort to address decades of underinvestment in bronchiectasis research, education and clinical care, the European Multicentre Bronchiectasis Audit and Research Collaboration (EMBARC) was established in 2012 as a collaborative pan-European network to bring together bronchiectasis researchers. The European Respiratory Society officially funded EMBARC in 2013 as a Clinical Research Collaboration, providing support and infrastructure to allow the project to grow. EMBARC has now established an international bronchiectasis registry that is active in more than 30 countries both within and outside Europe. Beyond the registry, the network participates in designing and facilitating clinical trials, has set international research priorities, promotes education and has participated in producing the first international bronchiectasis guidelines. This manuscript article the development, structure and achievements of EMBARC from 2012 to 2017. To understand the role of Clinical Research Collaborations as the major way in which the European Respiratory Society can stimulate clinical research in different disease areasTo understand some of the key features of successful disease registriesTo review key epidemiological, clinical and translational studies of bronchiectasis contributed by the European Multicentre Bronchiectasis Audit and Research Collaboration (EMBARC) project in the past 5 yearsTo understand the key research priorities identified by EMBARC for the next 5 years.

Influences upon pediatricians’ willingness to refer patients to clinical research

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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

Systematic collection of patient reported outcome research data: A checklist for clinical research professionals.

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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.

Negotiation skills for clinical research professionals

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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.

Negotiation skills for clinical research professionals

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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

Progress in clinical research of asteroid hyalosis

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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.

The social value of clinical research.

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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

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

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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

Characteristics desired in clinical data warehouse for biomedical research.

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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.

Genetics Research Discovered in a Bestseller | Poster

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By Nancy Parrish, Staff Writer One morning in early January, Amar Klar sat down at his computer and found an e-mail with a curious message from a colleague. While reading a bestselling novel, The Marriage Plot by Jeffrey Eugenides, his colleague, a professor at Princeton University, found a description of research on yeast genetics that was surprisingly similar to Klar’s early

Discover Earth: an earth system science program for libraries and their communities

Science.gov (United States)

Dusenbery, P.

2011-12-01

The view from space has deepened our understanding of Earth as a global, dynamic system. Instruments on satellites and spacecraft, coupled with advances in ground-based research, have provided us with astonishing new perspectives of our planet. Now more than ever, enhancing the public's understanding of Earth's physical and biological systems is vital to helping citizens make informed policy decisions especially when they are faced with the consequences of global climate change. While the focus for education reform is on school improvement, there is considerable research that supports the role that out-of-school experiences can play in student achievement. Libraries provide an untapped resource for engaging underserved youth and their families in fostering an appreciation and deeper understanding of science and technology topics. The Space Science Institute's National Center for Interactive Learning (NCIL) in partnership with the American Library Association (ALA), the Lunar and Planetary Institute (LPI), and the National Girls Collaborative Project (NGCP) have received funding from NSF to develop a national project called the STAR Library Education Network: a hands-on learning program for libraries and their communities (or STAR-Net for short). STAR stands for Science-Technology, Activities and Resources. STAR-Net includes two exhibitions: Discover Earth and Discover Tech. The Discover Earth exhibition will focus on local earth science topics-such as weather, water cycle, and ecosystem changes-as well as a global view of our changing planet. The main take-away message (or Big Idea) for this exhibition is that the global environment changes - and is changed by - the host community's local environment. The project team is testing whether this approach will be a good strategy for engaging the public, especially in rural America. This presentation will provide an overview of the Discover Earth project and how it is integrating climate change ideas into the exhibit

Clinical diabetes research using data mining: a Canadian perspective.

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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.

Discovering objects in a blood recipient information system.

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Qiu, D; Junghans, G; Marquardt, K; Kroll, H; Mueller-Eckhardt, C; Dudeck, J

1995-01-01

Application of object-oriented (OO) methodologies has been generally considered as a solution to the problem of improving the software development process and managing the so-called software crisis. Among them, object-oriented analysis (OOA) is the most essential and is a vital prerequisite for the successful use of other OO methodologies. Though there are already a good deal of OOA methods published, the most important aspect common to all these methods: discovering objects classes truly relevant to the given problem domain, has remained a subject to be intensively researched. In this paper, using the successful development of a blood recipient information system as an example, we present our approach which is based on the conceptual framework of responsibility-driven OOA. In the discussion, we also suggest that it may be inadequate to simply attribute the software crisis to the waterfall model of the software development life-cycle. We are convinced that the real causes for the failure of some software and information systems should be sought in the methodologies used in some crucial phases of the software development process. Furthermore, a software system can also fail if object classes essential to the problem domain are not discovered, implemented and visualized, so that the real-world situation cannot be faithfully traced by it.

A systematic framework to discover pattern for web spam classification

OpenAIRE

Jelodar, Hamed; Wang, Yongli; Yuan, Chi; Jiang, Xiaohui

2017-01-01

Web spam is a big problem for search engine users in World Wide Web. They use deceptive techniques to achieve high rankings. Although many researchers have presented the different approach for classification and web spam detection still it is an open issue in computer science. Analyzing and evaluating these websites can be an effective step for discovering and categorizing the features of these websites. There are several methods and algorithms for detecting those websites, such as decision t...

Astronomers Discover Fastest-Spinning Pulsar

Science.gov (United States)

2006-01-01

Astronomers using the National Science Foundation's Robert C. Byrd Green Bank Telescope have discovered the fastest-spinning neutron star ever found, a 20-mile-diameter superdense pulsar whirling faster than the blades of a kitchen blender. Their work yields important new information about the nature of one of the most exotic forms of matter known in the Universe. Pulsar Graphic Pulsars Are Spinning Neutron Stars CREDIT: Bill Saxton, NRAO/AUI/NSF (Click on image for larger version) "We believe that the matter in neutron stars is denser than an atomic nucleus, but it is unclear by how much. Our observations of such a rapidly rotating star set a hard upper limit on its size, and hence on how dense the star can be.," said Jason Hessels, a graduate student at McGill University in Montreal. Hessels and his colleagues presented their findings to the American Astronomical Society's meeting in Washington, DC. Pulsars are spinning neutron stars that sling "lighthouse beams" of radio waves or light around as they spin. A neutron star is what is left after a massive star explodes at the end of its "normal" life. With no nuclear fuel left to produce energy to offset the stellar remnant's weight, its material is compressed to extreme densities. The pressure squeezes together most of its protons and electrons to form neutrons; hence, the name "neutron star." "Neutron stars are incredible laboratories for learning about the physics of the fundamental particles of nature, and this pulsar has given us an important new limit," explained Scott Ransom, an astronomer at the National Radio Astronomy Observatory and one of Hessels' collaborators on this work. The scientists discovered the pulsar, named PSR J1748-2446ad, in a globular cluster of stars called Terzan 5, located some 28,000 light-years from Earth in the constellation Sagittarius. The newly-discovered pulsar is spinning 716 times per second, or at 716 Hertz (Hz), readily beating the previous record of 642 Hz from a pulsar

ClinicalCodes: an online clinical codes repository to improve the validity and reproducibility of research using electronic medical records.

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Springate, David A; Kontopantelis, Evangelos; Ashcroft, Darren M; Olier, Ivan; Parisi, Rosa; Chamapiwa, Edmore; Reeves, David

2014-01-01

Lists of clinical codes are the foundation for research undertaken using electronic medical records (EMRs). If clinical code lists are not available, reviewers are unable to determine the validity of research, full study replication is impossible, researchers are unable to make effective comparisons between studies, and the construction of new code lists is subject to much duplication of effort. Despite this, the publication of clinical codes is rarely if ever a requirement for obtaining grants, validating protocols, or publishing research. In a representative sample of 450 EMR primary research articles indexed on PubMed, we found that only 19 (5.1%) were accompanied by a full set of published clinical codes and 32 (8.6%) stated that code lists were available on request. To help address these problems, we have built an online repository where researchers using EMRs can upload and download lists of clinical codes. The repository will enable clinical researchers to better validate EMR studies, build on previous code lists and compare disease definitions across studies. It will also assist health informaticians in replicating database studies, tracking changes in disease definitions or clinical coding practice through time and sharing clinical code information across platforms and data sources as research objects.

Reengineering Clinical Research Science: A Focus on Translational Research

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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…

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

Team building: electronic management-clinical translational research (eM-CTR) systems.

Science.gov (United States)

Cecchetti, Alfred A; Parmanto, Bambang; Vecchio, Marcella L; Ahmad, Sjarif; Buch, Shama; Zgheib, Nathalie K; Groark, Stephen J; Vemuganti, Anupama; Romkes, Marjorie; Sciurba, Frank; Donahoe, Michael P; Branch, Robert A

2009-12-01

Classical drug exposure: response studies in clinical pharmacology represent the quintessential prototype for Bench to Bedside-Clinical Translational Research. A fundamental premise of this approach is for a multidisciplinary team of researchers to design and execute complex, in-depth mechanistic studies conducted in relatively small groups of subjects. The infrastructure support for this genre of clinical research is not well-handled by scaling down of infrastructure used for large Phase III clinical trials. We describe a novel, integrated strategy, whose focus is to support and manage a study using an Information Hub, Communication Hub, and Data Hub design. This design is illustrated by an application to a series of varied projects sponsored by Special Clinical Centers of Research in chronic obstructive pulmonary disease at the University of Pittsburgh. In contrast to classical informatics support, it is readily scalable to large studies. Our experience suggests the culture consequences of research group self-empowerment is not only economically efficient but transformative to the research process.

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.

The European Multicentre Bronchiectasis Audit and Research Collaboration (EMBARC: experiences from a successful ERS Clinical Research Collaboration

Directory of Open Access Journals (Sweden)

James D. Chalmers

2017-09-01

To understand the role of Clinical Research Collaborations as the major way in which the European Respiratory Society can stimulate clinical research in different disease areas To understand some of the key features of successful disease registries To review key epidemiological, clinical and translational studies of bronchiectasis contributed by the European Multicentre Bronchiectasis Audit and Research Collaboration (EMBARC project in the past 5 years To understand the key research priorities identified by EMBARC for the next 5 years

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.

Developing a clinical trial unit to advance research in an academic institution.

Science.gov (United States)

Croghan, Ivana T; Viker, Steven D; Limper, Andrew H; Evans, Tamara K; Cornell, Alissa R; Ebbert, Jon O; Gertz, Morie A

2015-11-01

Research, clinical care, and education are the three cornerstones of academic health centers in the United States. The research climate has always been riddled with ebbs and flows, depending on funding availability. During a time of reduced funding, the number and scope of research studies have been reduced, and in some instances, a field of study has been eliminated. Recent reductions in the research funding landscape have led institutions to explore new ways to continue supporting research. Mayo Clinic in Rochester, MN has developed a clinical trial unit within the Department of Medicine, which provides shared resources for many researchers and serves as a solution for training and mentoring new investigators and study teams. By building on existing infrastructure and providing supplemental resources to existing research, the Department of Medicine clinical trial unit has evolved into an effective mechanism for conducting research. This article discusses the creation of a central unit to provide research support in clinical trials and presents the advantages, disadvantages, and required building blocks for such a unit. Copyright © 2015 Mayo Clinic. Published by Elsevier Inc. All rights reserved.

[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.

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...

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...

Conceptual framework for behavioral and social science in HIV vaccine clinical research.

Science.gov (United States)

Lau, Chuen-Yen; Swann, Edith M; Singh, Sagri; Kafaar, Zuhayr; Meissner, Helen I; Stansbury, James P

2011-10-13

HIV vaccine clinical research occurs within a context where biomedical science and social issues are interlinked. Previous HIV vaccine research has considered behavioral and social issues, but often treated them as independent of clinical research processes. Systematic attention to the intersection of behavioral and social issues within a defined clinical research framework is needed to address gaps, such as those related to participation in trials, completion of trials, and the overall research experience. Rigorous attention to these issues at project inception can inform trial design and conduct by matching research approaches to the context in which trials are to be conducted. Conducting behavioral and social sciences research concurrent with vaccine clinical research is important because it can help identify potential barriers to trial implementation, as well as ultimate acceptance and dissemination of trial results. We therefore propose a conceptual framework for behavioral and social science in HIV vaccine clinical research and use examples from the behavioral and social science literature to demonstrate how the model can facilitate identification of significant areas meriting additional exploration. Standardized use of the conceptual framework could improve HIV vaccine clinical research efficiency and relevance. Published by Elsevier Ltd.

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) ...

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

Cancer Center Clinic and Research Team Perceptions of Identity and Interactions.

Science.gov (United States)

Reimer, Torsten; Lee, Simon J Craddock; Garcia, Sandra; Gill, Mary; Duncan, Tobi; Williams, Erin L; Gerber, David E

2017-12-01

Conduct of cancer clinical trials requires coordination and cooperation among research and clinic teams. Diffusion of and confusion about responsibility may occur if team members' perceptions of roles and objectives do not align. These factors are critical to the success of cancer centers but are poorly studied. We developed a survey adapting components of the Adapted Team Climate Inventory, Measure of Team Identification, and Measure of In-Group Bias. Surveys were administered to research and clinic staff at a National Cancer Institute-designated comprehensive cancer center. Data were analyzed using descriptive statistics, t tests, and analyses of variance. Responses were received from 105 staff (clinic, n = 55; research, n = 50; 61% response rate). Compared with clinic staff, research staff identified more strongly with their own group ( P teams, we also identified key differences, including perceptions of goal clarity and sharing, understanding and alignment with cancer center goals, and importance of outcomes. Future studies should examine how variation in perceptions and group dynamics between clinic and research teams may impact function and processes of cancer care.

Collaborative partnership and the social value of clinical research: a qualitative secondary analysis.

Science.gov (United States)

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

2017-10-25

Protecting human subjects from being exploited is one of the main ethical challenges for clinical research. However, there is also a responsibility to protect and respect the communities who are hosting the research. Recently, attention has focused on the most efficient way of carrying out clinical research, so that it benefits society by providing valuable research while simultaneously protecting and respecting the human subjects and the communities where the research is conducted. Collaboration between partners plays an important role and that is why we carried out a study to describe how collaborative partnership and social value are emerging in clinical research. A supra-analysis design for qualitative descriptive secondary analysis was employed to consider a novel research question that pertained to nurse leaders' perceptions of ethical recruitment in clinical research and the ethics-related aspects of clinical research from the perspective of administrative staff. The data consisted of two separate pre-existing datasets, comprising 451 pages from 41 interviews, and we considered the research question by using deductive-inductive content analysis with NVivo software. A deductive analysis matrix was generated on the basis of two requirements, namely collaborative partnership and social value, as presented in An Ethical Framework for Biomedical Research by Emanuel et al. The findings showed that collaborative partnership was a cornerstone for ethical clinical research and ways to foster inter-partner collaboration were indicated, such as supporting mutual respect and equality, shared goals and clearly defined roles and responsibilities. In addition, the social value of clinical research was an important precondition for ethical clinical research and its realisation required the research partners to demonstrate collaboration and shared responsibility during the research process. However, concerns emerged that the multidimensional meaning of clinical research for

The impact of clinical research activities on communities in rural Africa: the development of the Clinical Research Unit of Nanoro (CRUN) in Burkina Faso.

Science.gov (United States)

Tinto, Halidou; Valea, Innocent; Sorgho, Hermann; Tahita, Marc Christian; Traore, Maminata; Bihoun, Biébo; Guiraud, Issa; Kpoda, Hervé; Rouamba, Jérémi; Ouédraogo, Sayouba; Lompo, Palpouguini; Yara, Sandrine; Kabore, William; Ouédraogo, Jean-Bosco; Guiguemdé, Robert Tinga; Binka, Fred N; Ogutu, Bernhards

2014-03-22

The opportunities for developing new drugs and vaccines for malaria control look brighter now than ten years ago. However, there are few places in sub-Saharan Africa with the necessary infrastructure and expertise to support such research in compliance to international standards of clinical research (ICH-GCP). The Clinical Research Unit of Nanoro (CRUN) was founded in 2008 to provide a much-needed GCP-compliant clinical trial platform for an imminent large-scale Phase 3 malaria vaccine trial. A dynamic approach was used that entailed developing the required infrastructure and human resources, while engaging local communities in the process as key stakeholders. This provided a better understanding and ownership of the research activities by the local population. Within five years (2008-2013), the CRUN set up a fully and well-equipped GCP-compliant clinical trial research facility, which enabled to attract 25 grants. The research team grew from ten health workers prior to 2008 to 254 in 2013. A Health and Demographic Surveillance System (HDSS), which covers a total population of about 60,000 people in 24 villages was set up in the district. The local community contributed to the development of the facility through the leadership of the king and the mayor of Nanoro. As a result of their active advocacy, the government extended the national electrical grid to the new research center, and later to the entire village. This produced a positive impact on the community's quality of life. The quality of health care improved substantially, due to the creation of more elaborate clinical laboratory services and the acquisition of state-of-the-art equipment. Involving the community in the key steps of establishing the centre provided the foundation for what was to become the CRUN success story. This experience demonstrates that when clinical trials research sites are carefully developed and implemented, they can have a positive and powerful impact on local communities in

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...

The 3D model of debriefing: defusing, discovering, and deepening.

Science.gov (United States)

Zigmont, Jason J; Kappus, Liana J; Sudikoff, Stephanie N

2011-04-01

The experiential learning process involves participation in key experiences and analysis of those experiences. In health care, these experiences can occur through high-fidelity simulation or in the actual clinical setting. The most important component of this process is the postexperience analysis or debriefing. During the debriefing, individuals must reflect upon the experience, identify the mental models that led to behaviors or cognitive processes, and then build or enhance new mental models to be used in future experiences. On the basis of adult learning theory, the Kolb Experiential Learning Cycle, and the Learning Outcomes Model, we structured a framework for facilitators of debriefings entitled "the 3D Model of Debriefing: Defusing, Discovering, and Deepening." It incorporates common phases prevalent in the debriefing literature, including description of and reactions to the experience, analysis of behaviors, and application or synthesis of new knowledge into clinical practice. It can be used to enhance learning after real or simulated events. Copyright © 2011 Elsevier Inc. All rights reserved.

Training Needs of Clinical and Research Professionals to Optimize Minority Recruitment and Retention in Cancer Clinical Trials.

Science.gov (United States)

Niranjan, Soumya J; Durant, Raegan W; Wenzel, Jennifer A; Cook, Elise D; Fouad, Mona N; Vickers, Selwyn M; Konety, Badrinath R; Rutland, Sarah B; Simoni, Zachary R; Martin, Michelle Y

2017-08-03

The study of disparities in minority recruitment to cancer clinical trials has focused primarily on inquiries among minority patient populations. However, clinical trial recruitment is complex and requires a broader appreciation of the multiple factors that influence minority participation. One area that has received little attention is minority recruitment training for professionals who assume various roles in the clinical trial recruitment process. Therefore, we assessed the perspectives of cancer center clinical and research personnel on their training and education needs toward minority recruitment for cancer clinical trials. Ninety-one qualitative interviews were conducted at five U.S. cancer centers among four stakeholder groups: cancer center leaders, principal investigators, referring clinicians, and research staff. Interviews were recorded and transcribed. Qualitative analyses focused on response data related to training for minority recruitment for cancer clinical trials. Four prominent themes were identified: (1) Research personnel are not currently being trained to focus on recruitment and retention of minority populations; (2) Training for minority recruitment and retention provides for a specific focus on factors influencing minority research participation; (3) Training on cultural awareness may help to bridge cultural gaps between potential minority participants and research professionals; (4) Views differ regarding the importance of research personnel training designed to focus on recruitment of minority populations. There is a lack of systematic training for minority recruitment. Many stakeholders acknowledged the benefits of minority recruitment training and welcomed training that focuses on increasing cultural awareness to increase the participation of minorities in cancer clinical trials.

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.

THE ROLE OF LAPAROSCOPY IN DISCOVERING THE CAUSES OF CHRONIC PELVIC PAIN

Directory of Open Access Journals (Sweden)

Jadranka Domazet Fink

2003-12-01

Full Text Available Background. The aim of this study was to assess the share of organic changes in patients with chronic pelvic pain (CPP as well as evaluate the need for invasive CPP diagnostics – laparoscopy.Methods. The data for the analysis were gathered retrospectively from the descriptions of 287 CPP patients who were treated at the Clinic of Gynaecology in Ljubljana from 1993 to 1999. In this analysis the share of laparoscopically established organic causes of CPP was assessed and the findings of invasive (laparoscopy and non-invasive diagnostics (clinical status and ultrasound were compared.Results. Out of 287 patients, 272 underwent laparoscopy, 7 underwent laparotomy while 8 were only observed. As regards organic CPP causes, an organic cause was established in 70.7% patients through laparoscopy. The most frequently observed phenomena were adhesions, namely in 97 (35.7% patients, endometriosis in 68 (25.0% and pelvic varices in 29 (10% patients.By comparing the results of invasive and non-invasive diagnostics it was established that up to three times more organic changes – a possible cause of CPP – can be discovered through laparoscopy than through the use of non-invasive diagnostics methods.Conclusions. Laparoscopy is considered to be the most reliable method of diagnostics and detection of organic causes of CPP. An adequate psychological treatment within a multidisciplinary approach is necessary in patients in whom an organic cause of CPP can not be discovered in their genital tract.

[Clinical research outside of teaching hospitals: Current situation in north-eastern France].

Science.gov (United States)

Goetz, C; Dupoux, A; Déloy, L; Hertz, C; Jeanmaire, T; Parneix, N

2015-04-01

Most clinical research in France takes place in teaching hospitals. There are, however, many advantages to developing it in other hospitals: access to innovative treatments, improvement in healthcare quality, attractiveness of hospitals, increased trial inclusion rates and reduced selection bias. The objectives of our study were to report on the current situation of clinical research outside teaching hospitals. A three-stage survey was conducted between January 2012 and May 2013 in non-teaching hospitals of north-eastern France. First, questionnaires were sent to administrative and medical boards of all hospitals with more than 100 beds, then to head doctors of every department in hospitals with more than 300 beds and finally meetings were organized with members of 20 selected hospitals. The administrative and medical boards of 85 hospitals participated in the first stage of the survey; half of these hospitals were engaged in clinical research activities and for 10 the internal structuring was cross-disciplinary. Answers from 178 departments were obtained during the second stage; 47% reported a clinical research activity. Meetings with research teams in 20 hospitals allowed us to identify difficulties concerning research funding, transversal organization and sponsoring. Clinical research existed in more than half of the respondent non-teaching hospitals. Obstacles to its development can be grouped in three categories: 1) internal structuring of clinical research, 2) access to information and knowledge of how clinical research functions and to interlocutors outside the hospital and 3) access to skills necessary to sponsor clinical research. Copyright © 2015 Elsevier Masson SAS. All rights reserved.

Detecting dissonance in clinical and research workflow for translational psychiatric registries.

Science.gov (United States)

Cofiel, Luciana; Bassi, Débora U; Ray, Ryan Kumar; Pietrobon, Ricardo; Brentani, Helena

2013-01-01

The interplay between the workflow for clinical tasks and research data collection is often overlooked, ultimately making it ineffective. To the best of our knowledge, no previous studies have developed standards that allow for the comparison of workflow models derived from clinical and research tasks toward the improvement of data collection processes. In this study we used the term dissonance for the occurrences where there was a discord between clinical and research workflows. We developed workflow models for a translational research study in psychiatry and the clinic where its data collection was carried out. After identifying points of dissonance between clinical and research models we derived a corresponding classification system that ultimately enabled us to re-engineer the data collection workflow. We considered (1) the number of patients approached for enrollment and (2) the number of patients enrolled in the study as indicators of efficiency in research workflow. We also recorded the number of dissonances before and after the workflow modification. We identified 22 episodes of dissonance across 6 dissonance categories: actor, communication, information, artifact, time, and space. We were able to eliminate 18 episodes of dissonance and increase the number of patients approached and enrolled in research study trough workflow modification. The classification developed in this study is useful for guiding the identification of dissonances and reveal modifications required to align the workflow of data collection and the clinical setting. The methodology described in this study can be used by researchers to standardize data collection process.

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

Feasibility of encoding the Institute for Clinical Systems Improvement Depression Guideline using the Omaha System.

Science.gov (United States)

Monsen, Karen A; Neely, Claire; Oftedahl, Gary; Kerr, Madeleine J; Pietruszewski, Pam; Farri, Oladimeji

2012-08-01

Evidence-based clinical guidelines are being developed to bridge the gap between research and practice with the goals of improving health care quality and population health. However, disseminating, implementing, and ensuring ongoing use of clinical guidelines in practice settings is challenging. The purpose of this study was to demonstrate the feasibility of encoding evidence-based clinical guidelines using the Omaha System. Clinical documentation with Omaha System-encoded guidelines generates individualized, meaningful data suitable for program evaluation and health care quality research. The use of encoded guidelines within the electronic health record has potential to reinforce use of guidelines, and thus improve health care quality and population health. Research using Omaha System data generated by clinicians has potential to discover new knowledge related to guideline use and effectiveness. Copyright © 2012 Elsevier Inc. All rights reserved.

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.

Data from a targeted proteomics approach to discover biomarkers in saliva for the clinical diagnosis of periodontitis

Directory of Open Access Journals (Sweden)

V. Orti

2018-06-01

Full Text Available This study focused on the search for new biomarkers based on liquid chromatography-multiple reaction monitoring (LC-MRM proteomics profiling of whole saliva from patients with periodontitis compared to healthy subjects. The LC-MRM profiling approach is a new and innovative method that has already been validated for the absolute and multiplexed quantification of biomarkers in several diseases. The dataset for this study was produced using LC-MRM to monitor protein levels in a multiplex assay, it provides clinical information on salivary biomarkers of periodontitis. The data presented here is an extension of our recently published research article (Mertens et al., 2017 [1]. Keywords: Clinical chemistry, Mass spectrometry, Proteomics, Saliva biochemistry, Oral disease, Periodontitis

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.

PARTAKE survey of public knowledge and perceptions of clinical research in India.

Directory of Open Access Journals (Sweden)

Tal Burt

Full Text Available BACKGROUND: A public that is an informed partner in clinical research is important for ethical, methodological, and operational reasons. There are indications that the public is unaware or misinformed, and not sufficiently engaged in clinical research but studies on the topic are lacking. PARTAKE - Public Awareness of Research for Therapeutic Advancements through Knowledge and Empowerment is a program aimed at increasing public awareness and partnership in clinical research. The PARTAKE Survey is a component of the program. OBJECTIVE: To study public knowledge and perceptions of clinical research. METHODS: A 40-item questionnaire combining multiple-choice and open-ended questions was administered to 175 English- or Hindi-speaking individuals in 8 public locations representing various socioeconomic strata in New Delhi, India. RESULTS: Interviewees were 18-84 old (mean: 39.6, SD ± 16.6, 23.6% female, 68.6% employed, 7.3% illiterate, 26.3% had heard of research, 2.9% had participated and 58.9% expressed willingness to participate in clinical research. The following perceptions were reported (% true/% false/% not aware: 'research benefits society' (94.1%/3.5%/2.3%, 'the government protects against unethical clinical research' (56.7%/26.3%/16.9%, 'research hospitals provide better care' (67.2%/8.7%/23.9%, 'confidentiality is adequately protected' (54.1%/12.3%/33.5%, 'participation in research is voluntary' (85.3%/5.8%/8.7%; 'participants treated like 'guinea pigs'' (20.7%/53.2%/26.0%, and 'compensation for participation is adequate' (24.7%/12.9%/62.3%. CONCLUSIONS: Results suggest the Indian public is aware of some key features of clinical research (e.g., purpose, value, voluntary nature of participation, and supports clinical research in general but is unaware of other key features (e.g., compensation, confidentiality, protection of human participants and exhibits some distrust in the conduct and reporting of clinical trials. Larger, cross

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.

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.

Participants' perception of pharmaceutical clinical research: a cross-sectional controlled study

Directory of Open Access Journals (Sweden)

González-Saldivar G

2016-04-01

Full Text Available Gerardo González-Saldivar,1 René Rodríguez-Gutiérrez,2 José Luis Viramontes-Madrid,3 Alejandro Salcido-Montenegro,2 Kevin Erick Gabriel Carlos-Reyna,2 Andrés Marcelo Treviño-Alvarez,2 Neri Alejandro Álvarez-Villalobos,4 José Gerardo González-González2 1Ophthalmology Department, 2Endocrinology Division, Hospital Universitario “Dr. José E. González”, Facultad de Medicina, Universidad Autónoma de Nuevo León, Monterrey, Nuevo León, 3Instituto Nacional de Salud Pública, Cuernavaca, Morelos, 4Medical Statistics Department, Hospital Universitario “Dr. José E. González”, Facultad de Medicina, Universidad Autónoma de Nuevo León, Monterrey, Nuevo León, Mexico Background: There is scarce scientific information assessing participants’ perception of pharmaceutical research in developed and developing countries concerning the risks, safety, and purpose of clinical trials.Methods: To assess the perception that 604 trial participants (cases and 604 nonparticipants (controls of pharmaceutical clinical trials have about pharmaceutical clinical research, we surveyed participants with one of four chronic diseases from 12 research sites throughout Mexico.Results: Participation in clinical trials positively influences the perception of pharmaceutical clinical research. More cases (65.4% than controls (50.7% perceived that the main purpose of pharmaceutical research is to cure more diseases and to do so more effectively. In addition, more cases considered that there are significant benefits when participating in a research study, such as excellent medical care and extra free services, with this being the most important motivation to participate for both groups (cases 52%, controls 54.5%. We also found a sense of trust in their physicians to deal with adverse events, and the perception that clinical research is a benefit to their health, rather than a risk. More controls believed that clinical trial participants’ health is put at risk

Efficient design of clinical trials and epidemiological research: is it possible?

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Lauer, Michael S; Gordon, David; Wei, Gina; Pearson, Gail

2017-08-01

Randomized clinical trials and large-scale, cohort studies continue to have a critical role in generating evidence in cardiovascular medicine; however, the increasing concern is that ballooning costs threaten the clinical trial enterprise. In this Perspectives article, we discuss the changing landscape of clinical research, and clinical trials in particular, focusing on reasons for the increasing costs and inefficiencies. These reasons include excessively complex design, overly restrictive inclusion and exclusion criteria, burdensome regulations, excessive source-data verification, and concerns about the effect of clinical research conduct on workflow. Thought leaders have called on the clinical research community to consider alternative, transformative business models, including those models that focus on simplicity and leveraging of digital resources. We present some examples of innovative approaches by which some investigators have successfully conducted large-scale, clinical trials at relatively low cost. These examples include randomized registry trials, cluster-randomized trials, adaptive trials, and trials that are fully embedded within digital clinical care or administrative platforms.

Translational Research from an Informatics Perspective

Science.gov (United States)

Bernstam, Elmer; Meric-Bernstam, Funda; Johnson-Throop, Kathy A.; Turley, James P.; Smith, Jack W.

2007-01-01

Clinical and translational research (CTR) is an essential part of a sustainable global health system. Informatics is now recognized as an important en-abler of CTR and informaticians are increasingly called upon to help CTR efforts. The US National Institutes of Health mandated biomedical informatics activity as part of its new national CTR grant initiative, the Clinical and Translational Science Award (CTSA). Traditionally, translational re-search was defined as the translation of laboratory discoveries to patient care (bench to bedside). We argue, however, that there are many other kinds of translational research. Indeed, translational re-search requires the translation of knowledge dis-covered in one domain to another domain and is therefore an information-based activity. In this panel, we will expand upon this view of translational research and present three different examples of translation to illustrate the point: 1) bench to bedside, 2) Earth to space and 3) academia to community. We will conclude with a discussion of our local translational research efforts that draw on each of the three examples.

PARTAKE Survey of Public Knowledge and Perceptions of Clinical Research in India

Science.gov (United States)

Burt, Tal; Dhillon, Savita; Sharma, Pooja; Khan, Danish; MV, Deepa; Alam, Sazid; Jain, Sarika; Alapati, Bhavana; Mittal, Sanjay; Singh, Padam

2013-01-01

Background A public that is an informed partner in clinical research is important for ethical, methodological, and operational reasons. There are indications that the public is unaware or misinformed, and not sufficiently engaged in clinical research but studies on the topic are lacking. PARTAKE – Public Awareness of Research for Therapeutic Advancements through Knowledge and Empowerment is a program aimed at increasing public awareness and partnership in clinical research. The PARTAKE Survey is a component of the program. Objective To study public knowledge and perceptions of clinical research. Methods A 40-item questionnaire combining multiple-choice and open-ended questions was administered to 175 English- or Hindi-speaking individuals in 8 public locations representing various socioeconomic strata in New Delhi, India. Results Interviewees were 18–84 old (mean: 39.6, SD±16.6), 23.6% female, 68.6% employed, 7.3% illiterate, 26.3% had heard of research, 2.9% had participated and 58.9% expressed willingness to participate in clinical research. The following perceptions were reported (% true/% false/% not aware): ‘research benefits society’ (94.1%/3.5%/2.3%), ‘the government protects against unethical clinical research’ (56.7%/26.3%/16.9%), ‘research hospitals provide better care’ (67.2%/8.7%/23.9%), ‘confidentiality is adequately protected’ (54.1%/12.3%/33.5%), ‘participation in research is voluntary’ (85.3%/5.8%/8.7%); ‘participants treated like ‘guinea pigs’’ (20.7%/53.2%/26.0%), and ‘compensation for participation is adequate’ (24.7%/12.9%/62.3%). Conclusions Results suggest the Indian public is aware of some key features of clinical research (e.g., purpose, value, voluntary nature of participation), and supports clinical research in general but is unaware of other key features (e.g., compensation, confidentiality, protection of human participants) and exhibits some distrust in the conduct and reporting of clinical trials

A pragmatic analysis of vulnerability in clinical research.

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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.

Research fellowship programs as a pathway for training independent clinical pharmacy scientists.

Science.gov (United States)

Mueller, Eric W; Bishop, Jeffrey R; Kanaan, Abir O; Kiser, Tyree H; Phan, Hanna; Yang, Katherine Y

2015-03-01

The American College of Clinical Pharmacy (ACCP) Research Affairs Committee published a commentary in 2013 on training clinical pharmacy scientists in the context of changes in economic, professional, political, and research environments. The commentary centered on the opportunities for pharmacists in clinical/translational research including strategies for ACCP, colleges of pharmacy, and the profession to increase the number and impact of clinical pharmacy scientists. A postdoctoral fellowship is cited as a current training pathway, capable of producing independent and productive pharmacy researchers. However, a decline in the number of programs, decreased funding availability, and variability in fellowship program activities and research focus have brought into question the relevance of this research training pathway to meet demand and opportunities. In response to these points, this commentary examines the state of research fellowship training including the current ACCP research fellowship review process, the need for standardization of research fellowship programs, and strategies to strengthen and promote research fellowships as relevant researcher training pathways. © 2015 Pharmacotherapy Publications, Inc.

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

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.

[Up-to-date research for clinical application in breast cancer].

Science.gov (United States)

Koyama, Hiroki

2006-03-01

Breast cancer is still increasing in number of patients affected annually, with a peak incidence between 40-50 years of age. Various researches to control the disease have been attracting much attention scientifically and socially. Clinical application of trastuzumab (Herceptin), sentinel node biopsy to avoid unnecessary axillary dissection and individualized use of chemo-endocrine therapy as indicated by large scale clinical trials are among the recent successful results by pre-clinical and early clinical studies. In this context, the present special edition deals with articles on recent progress in breast cancer researches by leading scientists in this field. Hoping readers to understand, digest, and also to be stimulated by the updates for daily clinical practice.

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

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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.

Clinical reasoning and its application to nursing: concepts and research studies.

Science.gov (United States)

Banning, Maggi

2008-05-01

Clinical reasoning may be defined as "the process of applying knowledge and expertise to a clinical situation to develop a solution" [Carr, S., 2004. A framework for understanding clinical reasoning in community nursing. J. Clin. Nursing 13 (7), 850-857]. Several forms of reasoning exist each has its own merits and uses. Reasoning involves the processes of cognition or thinking and metacognition. In nursing, clinical reasoning skills are an expected component of expert and competent practise. Nurse research studies have identified concepts, processes and thinking strategies that might underpin the clinical reasoning used by pre-registration nurses and experienced nurses. Much of the available research on reasoning is based on the use of the think aloud approach. Although this is a useful method, it is dependent on ability to describe and verbalise the reasoning process. More nursing research is needed to explore the clinical reasoning process. Investment in teaching and learning methods is needed to enhance clinical reasoning skills in nurses.

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...

Representing clinical communication knowledge through database management system integration.

Science.gov (United States)

Khairat, Saif; Craven, Catherine; Gong, Yang

2012-01-01

Clinical communication failures are considered the leading cause of medical errors [1]. The complexity of the clinical culture and the significant variance in training and education levels form a challenge to enhancing communication within the clinical team. In order to improve communication, a comprehensive understanding of the overall communication process in health care is required. In an attempt to further understand clinical communication, we conducted a thorough methodology literature review to identify strengths and limitations of previous approaches [2]. Our research proposes a new data collection method to study the clinical communication activities among Intensive Care Unit (ICU) clinical teams with a primary focus on the attending physician. In this paper, we present the first ICU communication instrument, and, we introduce the use of database management system to aid in discovering patterns and associations within our ICU communications data repository.

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

Metabolomics and Its Application in the Development of Discovering Biomarkers for Osteoporosis Research

Directory of Open Access Journals (Sweden)

Huanhuan Lv

2016-12-01

Full Text Available Osteoporosis is a progressive skeletal disorder characterized by low bone mass and increased risk of fracture in later life. The incidence and costs associated with treating osteoporosis cause heavy socio-economic burden. Currently, the diagnosis of osteoporosis mainly depends on bone mineral density and bone turnover markers. However, these indexes are not sensitive and accurate enough to reflect the osteoporosis progression. Metabolomics offers the potential for a holistic approach for clinical diagnoses and treatment, as well as understanding of the pathological mechanism of osteoporosis. In this review, we firstly describe the study subjects of osteoporosis and bio-sample preparation procedures for different analytic purposes, followed by illustrating the biomarkers with potentially predictive, diagnosis and pharmaceutical values when applied in osteoporosis research. Then, we summarize the published metabolic pathways related to osteoporosis. Furthermore, we discuss the importance of chronological data and combination of multi-omics in fully understanding osteoporosis. The application of metabolomics in osteoporosis could provide researchers the opportunity to gain new insight into the metabolic profiling and pathophysiological mechanisms. However, there is still much to be done to validate the potential biomarkers responsible for the progression of osteoporosis and there are still many details needed to be further elucidated.

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.

The Design and Development of a Technology Based Orientation Manual for Clinical Research Coordinators

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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…

Anatomy and histology of the newly discovered adipose sac structure within the labia majora: international original research.

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Ostrzenski, Adam; Krajewski, Pawel; Davis, Kern

2016-09-01

To determine whether there is any new anatomical structure present within the labia majora. A case serial study was executed on eleven consecutive fresh human female cadavers. Stratum-by-stratum dissections of the labia majora were performed. Twenty-two anatomic dissections of labia majora were completed. Eosin and Hematoxylin agents were used to stain newly discovered adipose sac's tissues of the labia majora and the cylinder-like structures, which cover condensed adipose tissues. The histology of these two structures was compared. All dissected labia majora demonstrated the presence of the anatomic existence of the adipose sac structure. Just under the dermis of the labia majora, the adipose sac was located, which was filled with lobules containing condensed fatty tissues in the form of cylinders. The histological investigation established that the well-organized fibro-connective-adipose tissues represented the adipose sac. The absence of descriptions of the adipose sac within the labia majora in traditional anatomic and gynecologic textbooks was noted. In this study group, the newly discovered adipose sac is consistently present within the anatomical structure of the labia majora. The well-organized fibro-connective-adipose tissue represents microscopic characteristic features of the adipose sac.

Clinical trials of boron neutron capture therapy [in humans] [at Beth Israel Deaconess Medical Center][at Brookhaven National Laboratory

International Nuclear Information System (INIS)

Wallace, Christine

2001-01-01

Assessment of research records of Boron Neutron Capture Therapy was conducted at Brookhaven National Laboratory and Beth Israel Deaconess Medical Center using the Code of Federal Regulations, FDA Regulations and Good Clinical Practice Guidelines. Clinical data were collected FR-om subjects' research charts, and differences in conduct of studies at both centers were examined. Records maintained at Brookhaven National Laboratory were not in compliance with regulatory standards. Beth Israel's records followed federal regulations. Deficiencies discovered at both sites are discussed in the reports

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.

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...

Assessing Clinical Trial-Associated Workload in Community-Based Research Programs Using the ASCO Clinical Trial Workload Assessment Tool.

Science.gov (United States)

Good, Marjorie J; Hurley, Patricia; Woo, Kaitlin M; Szczepanek, Connie; Stewart, Teresa; Robert, Nicholas; Lyss, Alan; Gönen, Mithat; Lilenbaum, Rogerio

2016-05-01

Clinical research program managers are regularly faced with the quandary of determining how much of a workload research staff members can manage while they balance clinical practice and still achieve clinical trial accrual goals, maintain data quality and protocol compliance, and stay within budget. A tool was developed to measure clinical trial-associated workload, to apply objective metrics toward documentation of work, and to provide clearer insight to better meet clinical research program challenges and aid in balancing staff workloads. A project was conducted to assess the feasibility and utility of using this tool in diverse research settings. Community-based research programs were recruited to collect and enter clinical trial-associated monthly workload data into a web-based tool for 6 consecutive months. Descriptive statistics were computed for self-reported program characteristics and workload data, including staff acuity scores and number of patient encounters. Fifty-one research programs that represented 30 states participated. Median staff acuity scores were highest for staff with patients enrolled in studies and receiving treatment, relative to staff with patients in follow-up status. Treatment trials typically resulted in higher median staff acuity, relative to cancer control, observational/registry, and prevention trials. Industry trials exhibited higher median staff acuity scores than trials sponsored by the National Institutes of Health/National Cancer Institute, academic institutions, or others. The results from this project demonstrate that trial-specific acuity measurement is a better measure of workload than simply counting the number of patients. The tool was shown to be feasible and useable in diverse community-based research settings. Copyright © 2016 by American Society of Clinical Oncology.

A Data-driven Concept Schema for Defining Clinical Research Data Needs

Science.gov (United States)

Hruby, Gregory W.; Hoxha, Julia; Ravichandran, Praveen Chandar; Mendonça, Eneida A.; Hanauer, David A; Weng, Chunhua

2016-01-01

OBJECTIVES The Patient, Intervention, Control/Comparison, and Outcome (PICO) framework is an effective technique for framing a clinical question. We aim to develop the counterpart of PICO to structure clinical research data needs. METHODS We use a data-driven approach to abstracting key concepts representing clinical research data needs by adapting and extending an expert-derived framework originally developed for defining cancer research data needs. We annotated clinical trial eligibility criteria, EHR data request logs, and data queries to electronic health records (EHR), to extract and harmonize concept classes representing clinical research data needs. We evaluated the class coverage, class preservation from the original framework, schema generalizability, schema understandability, and schema structural correctness through a semi-structured interview with eight multidisciplinary domain experts. We iteratively refined the schema based on the evaluations. RESULTS Our data-driven schema preserved 68% of the 63 classes from the original framework and covered 88% (73/82) of the classes proposed by evaluators. Class coverage for participants of different backgrounds ranged from 60% to 100% with a median value of 95% agreement among the individual evaluators. The schema was found understandable and structurally sound. CONCLUSIONS Our proposed schema may serve as the counterpart to PICO for improving the research data needs communication between researchers and informaticians. PMID:27185504

The role of Clinical Trial Units in investigator- and industry-initiated research projects.

Science.gov (United States)

von Niederhäusern, Belinda; Fabbro, Thomas; Pauli-Magnus, Christiane

2015-01-01

Six multidisciplinary competence centres (Clinical Trial Units, CTUs) in Basel, Berne, Geneva, Lausanne, St. Gallen and Zurich provide professional support to clinical researchers in the planning, implementation, conduct and evaluation of clinical studies. Through their coordinated network, these units promote high-quality, nationally harmonised and internationally standardised clinical research conduct in Switzerland. We will describe why this network has been established, how it has been successful in stilling the growing need for clinical research support, which training and education opportunities it offers, and how it created national awareness for the still-existing hurdles towards clinical research excellence in Switzerland. Taking the CTU Basel as an example, we show that a considerable number (25%) of the studies submitted for regulatory approval in 2013 were supported by the CTU, decreasing the number of findings in ethics reviews by about one-third. We conclude that these achievements, together with a Swiss national funding model for clinical research, and improved national coordination, will be critical factors to successfully position Swiss clinical research at the international forefront.

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.

Clinical reasoning skills in final-year dental students: A qualitative cross-curricula comparison.

Science.gov (United States)

Nafea, E T; Dennick, R

2018-05-01

The aim of this research was to explore the perceptions of undergraduate dental students regarding clinical reasoning skills and also discover the influences of different curriculum designs on the acquisition of these skills by students. Eighteen final-year students from three different dental schools with varied curricula and cultures participated in the current research. The research used qualitative methodology. The study took place in 2013-2014. Interviews captured the participants' own understanding of clinical reasoning and its acquisition plus they "talked through" a clinical problem using a "think-aloud" technique. Thematic analysis was used to analyse the transcripts of the recorded interviews. Results obtained were related to curriculum structure. Unfamiliarity with the term clinical reasoning was common in students. Students from different schools used different strategies to reason when discussing clinical vignettes. Clinical reasoning process was dominated by pattern recognition. Students' behaviours seemed to be influenced by cultural factors. This research contributes to a greater understanding of how students learn, understand and apply dental clinical reasoning which will improve educational practices in the future. © 2017 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

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.

Clinical nursing and midwifery research in African countries: a scoping review.

Science.gov (United States)

Sun, Carolyn; Larson, Elaine

2015-05-01

Globally, the nursing shortage has been deemed a crisis, but African countries have been hit hardest. Therefore, it is of utmost importance nurses use the best available evidence and that nursing research is targeted to address gaps in the evidence. To achieve this, an understanding of what is currently available and identification of gaps in clinical nursing research is critical. We performed a scoping review of existing literature to assess clinical nursing research conducted in all African countries over the past decade, identify gaps in clinical nursing and midwifery research, determine whether they match with health priorities for countries, and define priorities for regional clinical nursing research agendas to improve health outcomes. This is a scoping review of published clinical nursing research conducted in African countries. Systematic searches of literature published between January 01, 2004 and September 15, 2014 were performed in PubMed, Medline, CINHAL, and Embase. Research was included if it was conducted by nurses, included data obtained in African countries or regions within the African continent, published in a peer-reviewed journal with an abstract, and included patient outcomes. Abstracts were independently reviewed for inclusion by two authors. The following data were extracted: countries of publication and study, study type and design, journal, language, and topics of research. Gaps in the literature were identified. Initially, 1091 papers were identified with a final sample of 73 articles meeting inclusion criteria. Studies used 12 designs, were published in 35 journals published in five countries (including two African countries); 29% of the research was published in a single journal (Curatonis). Research was mostly qualitative (57%) and included twenty countries in Africa (38%). There were 12 major topics of study, most often midwifery/maternal/child health (43%), patient experiences (38%), and human immunodeficiency virus (HIV

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.

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.

Validation of the "United Registries for Clinical Assessment and Research" (UR-CARE), a European online registry for clinical care and research in Inflammatory Bowel Disease

DEFF Research Database (Denmark)

Burisch, Johan; Gisbert, Javier P; Siegmund, Britta

2018-01-01

Background: The "United Registries for Clinical Assessment and Research" (UR-CARE) database is an initiative of the European Crohn's and Colitis Organisation (ECCO) to facilitate daily patient care and research studies in inflammatory bowel disease (IBD). Herein, we sought to validate the database......-99%); Case 5: 91% (87-93%)]. These numbers did not differ significantly from those found 6 weeks later (NcNemar's test p>0.05). Conclusion: The UR-CARE database appears to be feasible, valid and reliable as a tool and easy to use regardless of prior user experience and level of clinical IBD experience. UR......-CARE has the potential to enhance future European collaborations regarding clinical research in IBD....

Health information exchanges--Unfulfilled promise as a data source for clinical research.

Science.gov (United States)

Parker, Carol; Weiner, Michael; Reeves, Mathew

2016-03-01

To determine the use of health information exchange organizations (HIEs) to support and conduct clinical research. This scoping review included US-based studies published between January 2003 and March 2014 that used data from an HIE to address at least one of three categories of research: clinical or epidemiological research, financial evaluation, or utilization of health services. Eligibility was not restricted to research on HIEs. Studies with research questions outside of the evaluation of HIEs themselves were sought. Eighteen articles met final study inclusion criteria from an initial list of 847 hits. Fifteen studies addressed a clinical or epidemiological research question, 6 addressed a financial consideration, and 8 addressed a utilization issue. Considerable overlap was found among the research categories: 13 articles addressed more than one category. Of the eighteen included studies, only two used HIE data to answer a research objective that was NOT specific to HIE use. Research designs were varied and ranged from observational studies, such as cohort and cross-sectional studies, to randomized trials. The 18 articles represent the involvement of a small number of HIEs; 7 of the studies were from a single HIE. This review demonstrates that HIE-provided information is available and used to answer clinical or epidemiological, financial, or utilization-based research questions; however, the majority of the studies using HIE data are done with the primary goal of evaluating the use and impact of HIEs on health care delivery and outcomes. As HIEs mature and become integrated parts of the health care industry, the authors anticipate that fewer studies will be published that describe or validate the role of HIEs, and more will use HIEs as multi-institutional data sources for conducting clinical research and improving health services and clinical outcomes. Articles identified in this review indicate the limited extent that HIE data are being used for clinical

Metabolomics for Biomarker Discovery: Moving to the Clinic

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Zhang, Aihua; Sun, Hui; Yan, Guangli; Wang, Ping; Wang, Xijun

2015-01-01

To improve the clinical course of diseases, more accurate diagnostic and assessment methods are required as early as possible. In order to achieve this, metabolomics offers new opportunities for biomarker discovery in complex diseases and may provide pathological understanding of diseases beyond traditional technologies. It is the systematic analysis of low-molecular-weight metabolites in biological samples and has become an important tool in clinical research and the diagnosis of human disease and has been applied to discovery and identification of the perturbed pathways. It provides a powerful approach to discover biomarkers in biological systems and offers a holistic approach with the promise to clinically enhance diagnostics. When carried out properly, it could provide insight into the understanding of the underlying mechanisms of diseases, help to identify patients at risk of disease, and predict the response to specific treatments. Currently, metabolomics has become an important tool in clinical research and the diagnosis of human disease and becomes a hot topic. This review will highlight the importance and benefit of metabolomics for identifying biomarkers that accurately screen potential biomarkers of diseases. PMID:26090402

Does clinical equipoise apply to cluster randomized trials in health research?

Science.gov (United States)

2011-01-01

This article is part of a series of papers examining ethical issues in cluster randomized trials (CRTs) in health research. In the introductory paper in this series, Weijer and colleagues set out six areas of inquiry that must be addressed if the cluster trial is to be set on a firm ethical foundation. This paper addresses the third of the questions posed, namely, does clinical equipoise apply to CRTs in health research? The ethical principle of beneficence is the moral obligation not to harm needlessly and, when possible, to promote the welfare of research subjects. Two related ethical problems have been discussed in the CRT literature. First, are control groups that receive only usual care unduly disadvantaged? Second, when accumulating data suggests the superiority of one intervention in a trial, is there an ethical obligation to act? In individually randomized trials involving patients, similar questions are addressed by the concept of clinical equipoise, that is, the ethical requirement that, at the start of a trial, there be a state of honest, professional disagreement in the community of expert practitioners as to the preferred treatment. Since CRTs may not involve physician-researchers and patient-subjects, the applicability of clinical equipoise to CRTs is uncertain. Here we argue that clinical equipoise may be usefully grounded in a trust relationship between the state and research subjects, and, as a result, clinical equipoise is applicable to CRTs. Clinical equipoise is used to argue that control groups receiving only usual care are not disadvantaged so long as the evidence supporting the experimental and control interventions is such that experts would disagree as to which is preferred. Further, while data accumulating during the course of a CRT may favor one intervention over another, clinical equipoise supports continuing the trial until the results are likely to be broadly convincing, often coinciding with the planned completion of the trial

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)

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.

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.

Drug-eluting stents: from bench-top to clinical research

NARCIS (Netherlands)

Basalus, Mounir Welson Zakhary

2013-01-01

The development of drug-eluting stents (DES) has improved the invasive treatment of obstructive coronary artery disease by reducing both, restenosis rate and need for reinterventions. This success resulted in a widespread utilization of DES in clinical practice and entailed many clinical research

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.

78 FR 70102 - Clinical Science Research and Development Service Cooperative Studies; Scientific Evaluation...

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2013-11-22

... DEPARTMENT OF VETERANS AFFAIRS Clinical Science Research and Development Service Cooperative... notice under the Federal Advisory Committee Act, 5 U.S.C. App. 2, that the Clinical Science Research and... Development Officer through the Director of the Clinical Science Research and Development Service on the...

78 FR 41198 - Clinical Science Research and Development Service Cooperative Studies Scientific Evaluation...

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2013-07-09

... DEPARTMENT OF VETERANS AFFAIRS Clinical Science Research and Development Service Cooperative... under the Federal Advisory Committee Act, 5 U.S.C. App. 2, that the Clinical Science Research and.... The Committee advises the Chief Research and Development Officer through the Director of the Clinical...

77 FR 72438 - Clinical Science Research and Development Service Cooperative Studies Scientific Evaluation...

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2012-12-05

... DEPARTMENT OF VETERANS AFFAIRS Clinical Science Research and Development Service Cooperative... under the Federal Advisory Committee Act, 5 U.S.C. App. 2, that the Clinical Science Research and... through the Director of the Clinical Science Research and Development Service on the relevance and...

78 FR 53015 - Clinical Science Research and Development Service Cooperative Studies Scientific Evaluation...

Science.gov (United States)

2013-08-27

... DEPARTMENT OF VETERANS AFFAIRS Clinical Science Research and Development Service Cooperative... under the Federal Advisory Committee Act, 5 U.S.C. App. 2, that the Clinical Science Research and... Clinical Science Research and Development Service on the relevance and feasibility of proposed projects and...

[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.

Five-year review of an international clinical research-training program

Directory of Open Access Journals (Sweden)

Suemoto CK

2015-04-01

Full Text Available Claudia Kimie Suemoto,1,2 Sherine Ismail,1,3 Paulo César Rodrigues Pinto Corrêa,1,4,5 Faiza Khawaja,1,6 Teodoro Jerves,1 Laura Pesantez,1 Ana Claudia Camargo Gonçalves Germani,1,7 Fabio Zaina,1,8 Augusto Cesar Soares dos Santos Junior,1,9,10 Ricardo Jorge de Oliveira Ferreira,1,11 Priyamvada Singh,1,12 Judy Vicente Paulo,1,13 Suely Reiko Matsubayashi,1,14 Liliane Pinto Vidor,1,15 Guilherme Andretta,1,16 Rita Tomás,1,17 Ben MW Illigens,1,18 Felipe Fregni1,18,19 1Collaborative Learning in Clinical Research Program, Principles and Practice of Clinical Research (PPCR, Department of Physical Medicine and Rehabilitation, Spaulding Rehabilitation Hospital and Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA; 2Discipline of Geriatrics, Department of Internal Medicine, University of São Paulo Medical School, São Paulo, Brazil; 3King Abdullah International Medical Research Center, King Saud bin Abdulaziz University for Health Sciences, Pharmaceutical Care Department, King Khalid Hospital, NGHA, Jeddah, Saudi Arabia; 4Discipline of Internal Medicine and Medical Semiology, Department of Internal Medicine, Federal University of Ouro Preto (UFOP Medical School, Ouro Preto, Brazil; 5Discipline of Pneumology, Department of Internal Medicine, Centro Universitário de Belo Horizonte (Uni-BH, Belo Horizonte, Brazil; 6Canadian Centre for Advanced Eye Therapeutics, Mississauga, ON, Canada; 7Department of Preventive Medicine, University of São Paulo Medical School, São Paulo, Brazil; 8Italian Scientific Spine Institute (ISICO, Milan, Italy; 9Hospital Osvaldo Rezende Franco, Betim, Brazil; 10Nucleo de Avaliação de Tecnologia em Saude, Universidade Federal de Minas Gerais, Belo Horizonte, Brazil; 11Department of Rheumatology, Centro Hospitalar e Universitário de Coimbra, Coimbra, Portugal; 12Department of Internal Medicine, Saint Vincent Hospital, Worcester, MA, USA; 13Portuguese Institute of Oncology, Coimbra, Portugal; 14Acupuncture

Emerging role of bioinformatics tools and software in evolution of clinical research

Directory of Open Access Journals (Sweden)

Supreet Kaur Gill

2016-01-01

Full Text Available Clinical research is making toiling efforts for promotion and wellbeing of the health status of the people. There is a rapid increase in number and severity of diseases like cancer, hepatitis, HIV etc, resulting in high morbidity and mortality. Clinical research involves drug discovery and development whereas clinical trials are performed to establish safety and efficacy of drugs. Drug discovery is a long process starting with the target identification, validation and lead optimization. This is followed by the preclinical trials, intensive clinical trials and eventually post marketing vigilance for drug safety. Softwares and the bioinformatics tools play a great role not only in the drug discovery but also in drug development. It involves the use of informatics in the development of new knowledge pertaining to health and disease, data management during clinical trials and to use clinical data for secondary research. In addition, new technology likes molecular docking, molecular dynamics simulation, proteomics and quantitative structure activity relationship in clinical research results in faster and easier drug discovery process. During the preclinical trials, the software is used for randomization to remove bias and to plan study design. In clinical trials software like electronic data capture, Remote data capture and electronic case report form (eCRF is used to store the data. eClinical, Oracle clinical are software used for clinical data management and for statistical analysis of the data. After the drug is marketed the safety of a drug could be monitored by drug safety software like Oracle Argus or ARISg. Therefore, softwares are used from the very early stages of drug designing, to drug development, clinical trials and during pharmacovigilance. This review describes different aspects related to application of computers and bioinformatics in drug designing, discovery and development, formulation designing and clinical research.

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.

[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.

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

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

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...

Big-pharmaceuticalisation: clinical trials and Contract Research Organisations in India.

Science.gov (United States)

Sariola, Salla; Ravindran, Deapica; Kumar, Anand; Jeffery, Roger

2015-04-01

The World Trade Organisation's Trade Related Intellectual Property Rights [TRIPS] agreement aimed to harmonise intellectual property rights and patent protection globally. In India, the signing of this agreement resulted in a sharp increase in clinical trials since 2005. The Indian government, along with larger Indian pharmaceutical companies, believed that they could change existing commercial research cultures through the promotion of basic research as well as attracting international clinical trials, and thus create an international level, innovation-based drug industry. The effects of the growth of these outsourced and off-shored clinical trials on local commercial knowledge production in India are still unclear. What has been the impact of the increasing scale and commercialisation of clinical research on corporate science in India? In this paper we describe Big-pharmaceuticalisation in India, whereby the local pharmaceutical industry is moving from generic manufacturing to innovative research. Using conceptual frameworks of pharmaceuticalisation and innovation, this paper analyses data from research conducted in 2010-2012 and describes how Contract Research Organisations (CROs) enable outsourcing of randomised control trials to India. Focussing on twenty-five semi-structured interviews CRO staff, we chart the changes in Indian pharmaceutical industry, and implications for local research cultures. We use Big-pharmaceuticalisation to extend the notion of pharmaceuticalisation to describe the spread of pharmaceutical research globally and illustrate how TRIPS has encouraged a concentration of capital in India, with large companies gaining increasing market share and using their market power to rewrite regulations and introduce new regulatory practices in their own interest. Contract Research Organisations, with relevant, new, epistemic skills and capacities, are both manifestations of the changes in commercial research cultures, as well as the vehicles to

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

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).

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.

Clinical nurses' attitudes towards research, management and organisational resources in a university hospital: part 1.

Science.gov (United States)

Akerjordet, Kristin; Lode, Kirsten; Severinsson, Elisabeth

2012-09-01

The aim of this study was to determine clinical nurses' interest in and motivation for research. An additional aim was to identify management and organisational resources in order to improve nurses' research capacity in practice. Clinical nurses find conducting research challenging, which accords with observations of the continuing research-practice gap. This descriptive cross-sectional survey sampled 364 clinical nurses from a university hospital on the west coast of Norway. The response rate was 61%. An increasingly positive attitude towards research emerged (40%), despite the fact that few were engaged in research-based activities. Clinical nurses emphasised that lack of designated time (60%), interest (31%) and knowledge (31%) constituted important research barriers, as did lack of research supervision and support (25%). Research supervision was one of the most significant needs to enhance clinical nurses' research skills, management and organisation of research activities (30%). Conscious efforts strategically built on clinical and academic collaborative networks are required to promote and sustain clinical nurses' research capacity. The findings of this survey should be useful in the building of clinical nurses' research capacity. © 2012 Blackwell Publishing Ltd.

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)

Resolving Rivalries and Realigning Goals: Challenges of Clinical and Research Multiteam Systems.

Science.gov (United States)

Gerber, David E; Reimer, Torsten; Williams, Erin L; Gill, Mary; Loudat Priddy, Laurin; Bergestuen, Deidi; Schiller, Joan H; Kirkpatrick, Haskell; Craddock Lee, Simon J

2016-11-01

This article describes the care processes for a 64-year-old man with newly diagnosed advanced non-small-cell lung cancer who was enrolled in a first-line clinical trial of a new immunotherapy regimen. The case highlights the concept of multiteam systems in cancer clinical research and clinical care. Because clinical research represents a highly dynamic entity-with studies frequently opening, closing, and undergoing modifications-concerted efforts of multiple teams are needed to respond to these changes while continuing to provide consistent, high-level care and timely, accurate clinical data. The case illustrates typical challenges of multiteam care processes. Compared with clinical tasks that are routinely performed by single teams, multiple-team care greatly increases the demands for communication, collaboration, cohesion, and coordination among team members. As the case illustrates, the described research team and clinical team are separated, resulting in suboptimal function. Individual team members interact predominantly with members of their own team. A considerable number of team members lack regular interaction with anyone outside their team. Accompanying this separation, the teams enact rivalries that impede collaboration. The teams have misaligned goals and competing priorities that create competition. Collective identity and cohesion across the two teams are low. Research team and clinical team members have limited knowledge of the roles and work of individuals outside their team. Recommendations to increase trust and collaboration are provided. Clinical providers and researchers may incorporate these themes into development and evaluation of multiteam systems, multidisciplinary teams, and cross-functional teams within their own institutions.

An Integrated Workflow For Secondary Use of Patient Data for Clinical Research.

Science.gov (United States)

Bouzillé, Guillaume; Sylvestre, Emmanuelle; Campillo-Gimenez, Boris; Renault, Eric; Ledieu, Thibault; Delamarre, Denis; Cuggia, Marc

2015-01-01

This work proposes an integrated workflow for secondary use of medical data to serve feasibility studies, and the prescreening and monitoring of research studies. All research issues are initially addressed by the Clinical Research Office through a research portal and subsequently redirected to relevant experts in the determined field of concentration. For secondary use of data, the workflow is then based on the clinical data warehouse of the hospital. A datamart with potentially eligible research candidates is constructed. Datamarts can either produce aggregated data, de-identified data, or identified data, according to the kind of study being treated. In conclusion, integrating the secondary use of data process into a general research workflow allows visibility of information technologies and improves the accessability of clinical data.

Use of the Culture Care Theory and ethnonursing method to discover how nursing faculty teach culture care.

Science.gov (United States)

Mixer, Sandra J

2008-04-01

As the world becomes increasingly multicultural, transcultural nursing education is critical to ensuring a culturally competent workforce. This paper presents a comprehensive review of literature and results of an ethnonursing pilot study using the Culture Care Theory (CCT) to discover how nursing faculty teach culture care. The literature revealed that despite 50 years of transcultural nursing knowledge development through theory, research and practice, there remains a lack of formal, integrated culture education in nursing. The importance of faculty providing generic and professional care to nursing students and using an organising framework to teach culture care was discovered. Additionally, care was essential for faculty health and well-being to enable faculty to teach culture care. This unique use of the theory and method demonstrates its usefulness in discovering and describing the complex nature of teaching culture care. Larger scale studies are predicted to further substantiate the CCT, building the discipline of nursing.

Decision mining revisited - Discovering overlapping rules

NARCIS (Netherlands)

Mannhardt, Felix; De Leoni, Massimiliano; Reijers, Hajo A.; Van Der Aalst, Wil M P

2016-01-01

Decision mining enriches process models with rules underlying decisions in processes using historical process execution data. Choices between multiple activities are specified through rules defined over process data. Existing decision mining methods focus on discovering mutually-exclusive rules,

Decision Mining Revisited - Discovering Overlapping Rules

NARCIS (Netherlands)

Mannhardt, F.; De Leoni, M.; Reijers, H.A.; van der Aalst, W.M.P.; Nurcan, S.; Soffer, P.; Bajec, M.; Eder, J.

2016-01-01

Decision mining enriches process models with rules underlying decisions in processes using historical process execution data. Choices between multiple activities are specified through rules defined over process data. Existing decision mining methods focus on discovering mutually-exclusive rules,

Discover Earth: An earth system science program for libraries and their communities

Science.gov (United States)

Curtis, L.; Dusenbery, P.

2010-12-01

The view from space has deepened our understanding of Earth as a global, dynamic system. Instruments on satellites and spacecraft, coupled with advances in ground-based research, have provided us with astonishing new perspectives of our planet. Now more than ever, enhancing the public’s understanding of Earth’s physical and biological systems is vital to helping citizens make informed policy decisions especially when they are faced with the consequences of global climate change. In spite of this relevance, there are many obstacles to achieving broad public understanding of key earth system science (ESS) concepts. Strategies for addressing climate change can only succeed with the full engagement of the general public. As reported by U.S. News and World Report in 2010, small towns in rural America are emerging as the front line in the climate change debate in the country. The Space Science Institute’s National Center for Interactive Learning (NCIL) in partnership with the American Library Association (ALA), the Lunar and Planetary Institute (LPI), and the National Girls Collaborative Project (NGCP) have received funding from NSF to develop a national project called the STAR Library Education Network: a hands-on learning program for libraries and their communities (or STAR-Net for short). STAR stands for Science-Technology, Activities and Resources. There are two distinct components of STAR-Net: Discover Earth and Discover Tech. While the focus for education reform is on school improvement, there is considerable research that supports the role that out-of-school experiences can play in student achievement. Libraries provide an untapped resource for engaging underserved youth and their families in fostering an appreciation and deeper understanding of science and technology topics. The overarching goal of the project is to reach underserved youth and their families with informal STEM learning experiences. The Discover Earth part of STAR_Net will produce ESS

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.

Encouraging student-driven clinical research in Germany: the CHIR-Net SIGMA network

Directory of Open Access Journals (Sweden)

Frey Pia-Elena

2017-11-01

Full Text Available Evidence should define and guide modern clinical care, yet many relevant questions in surgical practice remain unconfirmed by substantial data. Evidence-based medicine requires both the implementation of its principles in day-to-day work and the acquisition of new evidence preferably by randomized controlled trials and systematic reviews. Meaningful clinical research, however, is challenging to conduct, and its overall infrastructure in Germany was, until recently, considered poor compared to other leading countries. Although this has been significantly improved after the establishment of the Study Center of the German Surgical Society (SDGC and the surgical clinical trial network CHIR-Net, limited focus has been put on the training, teaching, and recruitment of medical students to become competent clinical researchers and clinician scientists. To ensure continuing comprehensive clinical research in surgery, CHIR-Net aims to establish a student-driven multicenter research network in Germany, which is embedded in both the national CHIR-Net and the pan-European and international frameworks. Student-Initiated German Medical Audits (SIGMA is a product of the strong collaboration between clinical scientists and medical trainees, enabling students to contribute to high-quality clinical trials. Additionally, participants are offered extensive training to support the next generation of research-active clinicians. Starting on 2018, SIGMA will perform its first multicenter observational study in Germany.

'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...

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

Perspectives for medical informatics. Reusing the electronic medical record for clinical research.

Science.gov (United States)

Prokosch, H U; Ganslandt, T

2009-01-01

Even though today most university hospitals have already implemented commercial hospital information systems and started to build up comprehensive electronic medical records, reuse of such data for data warehousing and research purposes is still very rare. Given this situation, the focus of this paper is to present an overview on exemplary projects, which have already tackled this challenge, reflect on current initiatives within the United States of America and the European Union to establish IT infrastructures for clinical and translational research, and draw attention to new challenges in this area. This paper does not intend to provide a fully comprehensive review on all the issues of clinical routine data reuse. It is based, however, on a presentation of a large variety of historical, but also most recent activities in data warehousing, data retrieval and linking medical informatics with translational research. The article presents an overview of the various international approaches to this issue and illustrates concepts and solutions which have been published, thus giving an impression of activities pursued in this field of medical informatics. Further, problems and open questions, which have also been named in the literature, are presented and three challenges (to establish comprehensive clinical data warehouses, to establish professional IT infrastructure applications supporting clinical trial data capture and to integrate medical record systems and clinical trial databases) related to this area of medical informatics are identified and presented. Translational biomedical research with the aim "to integrate bedside and biology" and to bridge the gap between clinical care and medical research today and in the years to come, provides a large and interesting field for medical informatics researchers. Especially the need for integrating clinical research projects with data repositories built up during documentation of routine clinical care, today still leaves

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.

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)

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

What specifications for a centre or network of excellence in clinical research?

Science.gov (United States)

Diebolt, Vincent; Lang, Marie; Thoby, Frédérique

2016-02-01

The Giens 2015 Workshop Round Table entitled "What specifications for a centre or network of excellence in clinical research?" took a viewpoint distinct from earlier work and studies on changes in clinical research activities in France. The purpose of the present work was to identify, starting from concrete examples, the main strengths and advantages of clinical research activity in France related, in part, to the background environment and also to the specific characteristics of the investigation centres considered to be among the most high-performance units in activity. The criteria retained were grouped into a set of specifications that could be used to establish a "label of excellence" upon which the different teams and clinical research centres could model themselves. It was thus considered that belonging to a centre or structured network with at least a national configuration, when this is possible for the medial topic in question, constitutes a real advantage. Four benchmarks were identified: the scientific and clinical expertise of the head investigator, as well as the qualification and operational capacity of the centre's team; definition and measurement of performance using clearly displayed indicators and evaluation procedures; the quality of the overall trial "process" and of each of its component steps; communication, because know-how and promotion go hand in hand, with the main objective of informing the professional and general public about the value of the research centre meeting the above-mentioned criteria, about its networks of competencies, and more generally, about the important assets of the background of clinical research in France. This sector of research is funded by the public authorities via calls for public grants, financial aids for structures supporting clinical research in the University Hospital Centres and other healthcare institutions allowing for a professionalization of the research occupations, and the national public health

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...

[Which research is needed to support clinical decision-making on integrative medicine? Can comparative effectiveness research close the gap?].

Science.gov (United States)

Witt, Claudia M; Huang, Wen-jing; Lao, Lixing; Berman, Brian M

2013-08-01

In clinical research on complementary and integrative medicine, experts and scientists have often pursued a research agenda in spite of an incomplete understanding of the needs of end users. Consequently, the majority of previous clinical trials have mainly assessed the efficacy of interventions. Scant data is available on their effectiveness. Comparative effectiveness research (CER) promises to support decision makers by generating evidence that compares the benefits and harms of best care options. This evidence, more generalizable than evidence generated by traditional randomized clinical trials (RCTs), is better suited to inform real-world care decisions. An emphasis on CER supports the development of the evidence base for clinical and policy decision-making. Whereas in most areas of complementary and integrative medicine data on CER is scarce, available acupuncture research already contributes to CER evidence. This paper will introduce CER and make suggestions for future research.

[Clinical research activity of the French cancer cooperative network: Overview and perspectives].

Science.gov (United States)

Dubois, Claire; Morin, Franck; Moro-Sibilot, Denis; Langlais, Alexandra; Seitz, Jean-François; Girault, Cécile; Salles, Gilles; Haioun, Corinne; Deschaseaux, Pascal; Casassus, Philippe; Mathiot, Claire; Pujade-Lauraine, Éric; Votan, Bénédicte; Louvet, Christophe; Delpeut, Christine; Bardet, Étienne; Vintonenko, Nadejda; Hoang Xuan, Khê; Vo, Maryline; Michon, Jean; Milleron, Bernard

The French Cancer Plan 2014-2019 stresses the importance of strengthening collaboration between all stakeholders involved in the fight against cancer, including cancer cooperative groups and intergroups. This survey aimed to describe the basics characteristics and clinical research activity among the Cancer Cooperative Groups (Groupes coopérateurs en oncologie). The second objective was to identify facilitators and barriers to their research activity. A questionnaire was sent to all the clinicians involved in 2014 as investigators in a clinical trial sponsored by one of the ten members of the Cancer Cooperative Groups network. The questions were related to their profile, research activity and the infrastructure existing within their healthcare center to support clinical research and related compliance activities. In total, 366 investigators responded to our survey. The academic clinical trials sponsored by the Cancer Cooperative Groups represented an important part of the research activity of the investigators in France in 2014. These academic groups contributed to the opening of many research sites throughout all regions in France. Factors associated with a higher participation of investigators (more than 10 patients enrolled in a trial over a year) include the existing support of healthcare professionals (more than 2 clinical research associate (CRA) OR=11.16 [3.82-32.6] compared to none) and the practice of their research activity in a University Hospital Center (CHU) rather than a Hospital Center (CH) (OR=2.15 [1.20-3.83]). This study highlighted factors that can strengthen investigator clinical research activities and subsequently improve patient access to evidence-based new cancer therapies in France. Copyright © 2017 Société Française du Cancer. Published by Elsevier Masson SAS. All rights reserved.

Integrating utilization-focused evaluation with business process modeling for clinical research improvement.

Science.gov (United States)

Kagan, Jonathan M; Rosas, Scott; Trochim, William M K

2010-10-01

New discoveries in basic science are creating extraordinary opportunities to design novel biomedical preventions and therapeutics for human disease. But the clinical evaluation of these new interventions is, in many instances, being hindered by a variety of legal, regulatory, policy and operational factors, few of which enhance research quality, the safety of study participants or research ethics. With the goal of helping increase the efficiency and effectiveness of clinical research, we have examined how the integration of utilization-focused evaluation with elements of business process modeling can reveal opportunities for systematic improvements in clinical research. Using data from the NIH global HIV/AIDS clinical trials networks, we analyzed the absolute and relative times required to traverse defined phases associated with specific activities within the clinical protocol lifecycle. Using simple median duration and Kaplan-Meyer survival analysis, we show how such time-based analyses can provide a rationale for the prioritization of research process analysis and re-engineering, as well as a means for statistically assessing the impact of policy modifications, resource utilization, re-engineered processes and best practices. Successfully applied, this approach can help researchers be more efficient in capitalizing on new science to speed the development of improved interventions for human disease.

Models to enhance research capacity and capability in clinical nurses: a narrative review.

Science.gov (United States)

O'Byrne, Louise; Smith, Sheree

2011-05-01

To identify models used as local initiatives to build capability and capacity in clinical nurses. The National Health Service, Nursing and Midwifery Council and the United Kingdom Clinical Research Collaboration all support the development of the building of research capability and capacity in clinical nurses in the UK. Narrative review. A literature search of databases (including Medline and Pubmed) using the search terms nursing research, research capacity and research capability combined with building, development, model and collaboration. Publications which included a description or methodological study of a structured initiative to tackle research capacity and capability development in clinical nurses were selected. Three models were found to be dominant in the literature. These comprised evidence-based practice, facilitative and experiential learning models. Strong leadership, organisational need and support management were elements found in all three models. Methodological issues were evident and pertain to small sample sizes, inconsistent and poorly defined outcomes along with a lack of data. Whilst the vision of a research ready and active National Health Service is to be applauded to date, there appears to be limited research on the best approach to support local initiatives for nurses that build research capability and capacity. Future studies will need to focus on well-defined objectives and outcomes to enable robust evidence to support local initiatives. To build research capability and capacity in clinical nurses, there is a need to evaluate models and determine the best approach that will provide clinical nurses with research opportunities. © 2010 Blackwell Publishing Ltd.

Using mixed methods to identify and answer clinically relevant research questions.

Science.gov (United States)

Shneerson, Catherine L; Gale, Nicola K

2015-06-01

The need for mixed methods research in answering health care questions is becoming increasingly recognized because of the complexity of factors that affect health outcomes. In this article, we argue for the value of using a qualitatively driven mixed method approach for identifying and answering clinically relevant research questions. This argument is illustrated by findings from a study on the self-management practices of cancer survivors and the exploration of one particular clinically relevant finding about higher uptake of self-management in cancer survivors who had received chemotherapy treatment compared with those who have not. A cross-sectional study generated findings that formed the basis for the qualitative study, by informing the purposive sampling strategy and generating new qualitative research questions. Using a quantitative research component to supplement a qualitative study can enhance the generalizability and clinical relevance of the findings and produce detailed, contextualized, and rich answers to research questions that would be unachievable through quantitative or qualitative methods alone. © The Author(s) 2015.

Dive and Discover: Bringing Oceanographic Research into the Classroom and to the General Public

Science.gov (United States)

Fornari, D. J.; Fino, D.; Humphris, S. E.; Fruth, L. L.; Dean, S.

2001-12-01

We have developed the "Dive and Discover" web site for use in classrooms and for the general public to provide near real-time, daily access to oceanographic research expeditions, particularly those using deep submergence vehicles operated by Woods Hole Oceanographic Institution. The site was one of five science sites nominated for a 2001 Webby Award, was selected by Scientific American as one of the top five sites in the category of earth and environmental science, and was one of Eisenhower National Clearinghouse's "digital dozen" for science resources. The web site consists of two major components. A series of educational modules provide both general educational information about the oceans and the people that study them, as well as cruise-specific information about the natural systems being studied, the participating scientists, and the data and sample-collecting methodologies and technologies being used. The second component consists of modules that allow access to near real-time updates of the progress of the cruise, images of seafloor features and animals, samples of data being collected and used on board, and general information about life on board. In addition, a Mail Buoy provides e-mail access for students to ask questions of the scientists on board the ship during the course of the expedition. COSI Toledo have a linked Educator's Companion that gives access to COSI project management tips, background information, activities, correlations to national science education standards, assessment tools, and a vast array of resources to assist educators in using the web site. We have worked with teachers and students from all over the United States to test, evaluate, and refine the web site during five cruises in the Pacific and Indian Oceans over the last two years. These cruises focused on various problems associated with mid-ocean ridge volcanism, and the chemical, physical and biological processes associated with seafloor hydrothermal activity. Our intention

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.

77 FR 31072 - Clinical Science Research and Development Service Cooperative Studies Scientific Evaluation...

Science.gov (United States)

2012-05-24

... DEPARTMENT OF VETERANS AFFAIRS Clinical Science Research and Development Service Cooperative... Development Officer through the Director of the Clinical Science Research and Development Service on the... notice under Public Law 92-463 (Federal Advisory Committee Act) that a meeting of the Clinical Science...

76 FR 19189 - Clinical Science Research and Development Service Cooperative Studies Scientific Evaluation...

Science.gov (United States)

2011-04-06

... DEPARTMENT OF VETERANS AFFAIRS Clinical Science Research and Development Service Cooperative... through the Director of the Clinical Science Research and Development Service on the relevance and... notice under Public Law 92-463 (Federal Advisory Committee Act) that a meeting of the Clinical Science...

76 FR 65781 - Clinical Science Research and Development Service Cooperative Studies Scientific Evaluation...

Science.gov (United States)

2011-10-24

... DEPARTMENT OF VETERANS AFFAIRS Clinical Science Research and Development Service Cooperative... Clinical Science Research and Development Service on the relevance and feasibility of proposed projects and... notice under Public Law 92-463 (Federal Advisory Committee Act) that a meeting of the Clinical Science...

75 FR 28686 - Clinical Science Research and Development Service; Cooperative Studies Scientific Evaluation...

Science.gov (United States)

2010-05-21

... DEPARTMENT OF VETERANS AFFAIRS Clinical Science Research and Development Service; Cooperative... through the Director of the Clinical Science Research and Development Service on the relevance and... notice under Public Law 92-463 (Federal Advisory Committee Act) that a meeting of the Clinical Science...

Sharing Privacy Protected and Statistically Sound Clinical Research Data Using Outsourced Data Storage

Directory of Open Access Journals (Sweden)

Geontae Noh

2014-01-01

Full Text Available It is critical to scientific progress to share clinical research data stored in outsourced generally available cloud computing services. Researchers are able to obtain valuable information that they would not otherwise be able to access; however, privacy concerns arise when sharing clinical data in these outsourced publicly available data storage services. HIPAA requires researchers to deidentify private information when disclosing clinical data for research purposes and describes two available methods for doing so. Unfortunately, both techniques degrade statistical accuracy. Therefore, the need to protect privacy presents a significant problem for data sharing between hospitals and researchers. In this paper, we propose a controlled secure aggregation protocol to secure both privacy and accuracy when researchers outsource their clinical research data for sharing. Since clinical data must remain private beyond a patient’s lifetime, we take advantage of lattice-based homomorphic encryption to guarantee long-term security against quantum computing attacks. Using lattice-based homomorphic encryption, we design an aggregation protocol that aggregates outsourced ciphertexts under distinct public keys. It enables researchers to get aggregated results from outsourced ciphertexts of distinct researchers. To the best of our knowledge, our protocol is the first aggregation protocol which can aggregate ciphertexts which are encrypted with distinct public keys.

[Introduction of neuroethics: out of clinic, beyond academia in human brain research].

Science.gov (United States)

Fukushi, Tamami; Sakura, Osamu

2008-11-01

Higher cognitive function in human brain is one of well-developed fields of neuroscience research in the 21st century. Especially functional magnetic resonance imaging (fMRI) and near infrared recording system have brought so many non-clinical researchers whose background is such as cognitive psychology, economics, politics, pedagogy, and so on, to the human brain mapping study. Authors have introduced the ethical issues related to incidental findings during the fMRI recording for non-clinical purpose, which is a typical problem derived from such expanded human brain research under non clinical condition, that is, neuroethics. In the present article we would introduce neuroethical issues in contexts of "out of clinic" and "beyond academia".

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.

75 FR 79446 - Clinical Science Research and Development Service; Cooperative Studies Scientific Evaluation...

Science.gov (United States)

2010-12-20

... DEPARTMENT OF VETERANS AFFAIRS Clinical Science Research and Development Service; Cooperative... Officer through the Director of the Clinical Science Research and Development Service on the relevance and... notice under Public Law 92-463 (Federal Advisory Committee Act) that a meeting of the Clinical Science...

76 FR 73781 - Clinical Science Research and Development Service; Cooperative Studies Scientific Evaluation...

Science.gov (United States)

2011-11-29

... DEPARTMENT OF VETERANS AFFAIRS Clinical Science Research and Development Service; Cooperative... Officer through the Director of the Clinical Science Research and Development Service on the relevance and... notice under Public Law 92-463 (Federal Advisory Committee Act) that a meeting of the Clinical Science...

An ontologically founded architecture for information systems in clinical and epidemiological research.

Science.gov (United States)

Uciteli, Alexandr; Groß, Silvia; Kireyev, Sergej; Herre, Heinrich

2011-08-09

This paper presents an ontologically founded basic architecture for information systems, which are intended to capture, represent, and maintain metadata for various domains of clinical and epidemiological research. Clinical trials exhibit an important basis for clinical research, and the accurate specification of metadata and their documentation and application in clinical and epidemiological study projects represents a significant expense in the project preparation and has a relevant impact on the value and quality of these studies.An ontological foundation of an information system provides a semantic framework for the precise specification of those entities which are presented in this system. This semantic framework should be grounded, according to our approach, on a suitable top-level ontology. Such an ontological foundation leads to a deeper understanding of the entities of the domain under consideration, and provides a common unifying semantic basis, which supports the integration of data and the interoperability between different information systems.The intended information systems will be applied to the field of clinical and epidemiological research and will provide, depending on the application context, a variety of functionalities. In the present paper, we focus on a basic architecture which might be common to all such information systems. The research, set forth in this paper, is included in a broader framework of clinical research and continues the work of the IMISE on these topics.

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

CRISPR/Cas9 for cancer research and therapy.

Science.gov (United States)

Zhan, Tianzuo; Rindtorff, Niklas; Betge, Johannes; Ebert, Matthias P; Boutros, Michael

2018-04-16

CRISPR/Cas9 has become a powerful method for making changes to the genome of many organisms. First discovered in bacteria as part of an adaptive immune system, CRISPR/Cas9 and modified versions have found a widespread use to engineer genomes and to activate or to repress the expression of genes. As such, CRISPR/Cas9 promises to accelerate cancer research by providing an efficient technology to dissect mechanisms of tumorigenesis, identify targets for drug development, and possibly arm cells for cell-based therapies. Here, we review current applications of the CRISPR/Cas9 technology for cancer research and therapy. We describe novel Cas9 variants and how they are used in functional genomics to discover novel cancer-specific vulnerabilities. Furthermore, we highlight the impact of CRISPR/Cas9 in generating organoid and mouse models of cancer. Finally, we provide an overview of the first clinical trials that apply CRISPR/Cas9 as a therapeutic approach against cancer. Copyright © 2018 The Authors. Published by Elsevier Ltd.. All rights reserved.

The evolving professional identity of the clinical research nurse: A qualitative exploration.

Science.gov (United States)

Kunhunny, Swapna; Salmon, Debra

2017-12-01

To examine the perspectives of CRNs in the UK on their professional role identity, in order to inform the professional practice of Clinical Research Nursing. Clinical research nurses (CRN) make a significant contribution to healthcare research within the UK and internationally. However, lack of clarity about their role, and scope of practice renders their contribution within the profession and in the minds of the wider public invisible. This has implications in terms of promoting the role nurses play not only in terms of recruitment, retention, and care of research participants but also as research leaders of the future. Exploratory qualitative design using thematic analysis conducted within a realist paradigm. Participants viewed the positive aspects of their identity 'as agents of change' who were fundamental to the clinical research process. Resourcefulness and the ability to guide members of the research team were valued as key to job satisfaction. Successful navigation through the complexity of advice, support, management and leadership tasks related to their role in caring for research patients were role affirming and generated a sense of pride. However, lack of recognition, clarity of the role and career development opportunities within an identified structure undermined the CRN identity and optimism about progression in the future. Participants reported feeling invisible to colleagues within the clinical community, isolated and excluded from wider nursing groups. The study describes UK CRN practice, highlighting the positive benefits and challenges associated with the role, including the need to support professional and career development to maximise their research contribution. This study provides nurses, health care and research organisations and academic nursing educators with a broadened understanding of the professional role, identity and context of clinical research nursing practice in the United Kingdom, with recommendations to improve its

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.

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.

Building Surgical Research Capacity Globally: Efficacy of a Clinical Research Course for Surgeons in Low-Resource Settings

Directory of Open Access Journals (Sweden)

Theodore A. Miclau

2017-11-01

Full Text Available Musculoskeletal injury confers an enormous burden of preventable disability and mortality in low- and moderate-income countries (LMICs. Appropriate orthopedic and trauma care services are lacking. Leading international health agencies emphasize the critical need to create and sustain research capacity in the developing world as a strategic factor in the establishment of functional, independent health systems. One aspect of building research capacity is partnership between developing and developed countries, and knowledge sharing via these collaborations. This study evaluated the efficacy of a short, intensive course designed to educate surgeons on fundamental aspects of clinical research using evidence-based medicine (EBM principles. Orthopedic surgeons from the United States and Canada presented a one-day course on the fundamentals of clinical research in Havana, Cuba. Knowledge acquisition was assessed on the part of course participants and surveyed current involvement with and attitudes toward clinical research. Questionnaires were presented to participants immediately preceding and following the course. The mean pre-test score was 43.9% (95% CI: 41.1–46.6%. The mean post-test score was 59.3% (95% CI: 56.5–62.1%. There were relative score increases in each subgroup based on professional level, subjective level of familiarity with EBM concepts, and subjective level of experience in research. This study establishes the short-term efficacy of an intensive course designed to impart knowledge in EBM and clinical research. Further study is necessary to determine the long-term benefits of this type of course. This may be a useful part of an overall strategy to build health research capacity in LMICs, ultimately contributing to improved access to high-quality surgical care.

Latent topic discovery of clinical concepts from hospital discharge summaries of a heterogeneous patient cohort.

Science.gov (United States)

Lehman, Li-Wei; Long, William; Saeed, Mohammed; Mark, Roger

2014-01-01

Patients in critical care often exhibit complex disease patterns. A fundamental challenge in clinical research is to identify clinical features that may be characteristic of adverse patient outcomes. In this work, we propose a data-driven approach for phenotype discovery of patients in critical care. We used Hierarchical Dirichlet Process (HDP) as a non-parametric topic modeling technique to automatically discover the latent "topic" structure of diseases, symptoms, and findings documented in hospital discharge summaries. We show that the latent topic structure can be used to reveal phenotypic patterns of diseases and symptoms shared across subgroups of a patient cohort, and may contain prognostic value in stratifying patients' post hospital discharge mortality risks. Using discharge summaries of a large patient cohort from the MIMIC II database, we evaluate the clinical utility of the discovered topic structure in identifying patients who are at high risk of mortality within one year post hospital discharge. We demonstrate that the learned topic structure has statistically significant associations with mortality post hospital discharge, and may provide valuable insights in defining new feature sets for predicting patient outcomes.

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.

NHS Trusts' clinical research activity and overall CQC performance - Is there a correlation?

Science.gov (United States)

Jonker, L; Fisher, S J

2015-11-01

Since the late 2000's, the creation of the National Institute for Health Research (NIHR) has transformed clinical research activity in the United Kingdom. This study sought to establish if there is a link between clinical research activity and overall NHS Trust performance. Retrospective cohort study. Data for NHS Trust performance were obtained from public databases, namely the Care Quality Commission (CQC) 2013 risk rating for overall performance, and 2012-13 NIHR records for clinical research activity. Applying Spearman's rank analysis, none of the Trust categories showed a correlation with CQC risk rating: small hospitals, r = -0.062 (P = 0.76; n = 27); medium, r = -0.224 (P = 0.13; n = 47); large, r = -0.008 (P = 0.96; n = 57); academic, r = -0.18 (P = 0.41; n = 24). Similar results were observed when CQC risk rating was compared with the number of different clinical research studies conducted per Trust. The degree of NIHR National Portfolio clinical research activity is not significantly related to CQC risk rating, used as an indicator of overall NHS Trust performance. Other studies have previously shown that increased research activity correlates with improved mortality rates, one component of CQC risk rating scores. Alternative tools may have to be explored to evaluate the impact of clinical research on NHS Trusts and its patients. Copyright © 2015 The Royal Society for Public Health. Published by Elsevier Ltd. All rights reserved.

An institutional review board-based clinical research quality assurance program.

Science.gov (United States)

Lad, Pramod M; Dahl, Rebecca

2013-01-01

Despite the acknowledged importance of quality assurance in the clinical research process, the problem of how such a program should be implemented at the level of an academic teaching hospital or a similar institution has not been addressed in the literature. Despite the fact that quality assurance is expected in programs which certify and accredit Institutional Review Boards (IRBs), very little is known about the role of the IRB in programs of clinical research quality assurance. In this article we consider the definition of clinical research quality assurance, and describe a program designed to achieve it. The key elements of such a program are education at the site level, which has both mandatory and voluntary components, and an auditing and monitoring program, which reinforces the education on quality assurance. The role of the IRB in achieving the program goals and the organizational placement of the quality assurance program within the IRB structure and function are important items of discussion.

Data Mining and Machine Learning Methods for Dementia Research.

Science.gov (United States)

Li, Rui

2018-01-01

Patient data in clinical research often includes large amounts of structured information, such as neuroimaging data, neuropsychological test results, and demographic variables. Given the various sources of information, we can develop computerized methods that can be a great help to clinicians to discover hidden patterns in the data. The computerized methods often employ data mining and machine learning algorithms, lending themselves as the computer-aided diagnosis (CAD) tool that assists clinicians in making diagnostic decisions. In this chapter, we review state-of-the-art methods used in dementia research, and briefly introduce some recently proposed algorithms subsequently.

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…

Did Viking discover life on Mars?

Science.gov (United States)

Klein, H. P.

1999-01-01

A major argument in the claim that life had been discovered during the Viking mission to Mars is that the results obtained in the Labeled Release (LR) experiment are analogous to those observed with terrestrial microorganisms. This assertion is critically examined and found to be implausible.

Nuclear medical approaches to clinical research; Nuklearmedizinische Ansaetze in der klinischen Forschung

Energy Technology Data Exchange (ETDEWEB)

Otte, Andreas; Nguyen, Tristan (eds.)

2009-11-15

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.

The discovered preference hypothesis - an empirical test

DEFF Research Database (Denmark)

Lundhede, Thomas; Ladenburg, Jacob; Olsen, Søren Bøye

Using stated preference methods for valuation of non-market goods is known to be vulnerable to a range of biases. Some authors claim that these so-called anomalies in effect render the methods useless for the purpose. However, the Discovered Preference Hypothesis, as put forth by Plott [31], offers...... an nterpretation and explanation of biases which entails that the stated preference methods need not to be completely written off. In this paper we conduct a test for the validity and relevance of the DPH interpretation of biases. In a choice experiment concerning preferences for protection of Danish nature areas...... as respondents evaluate more and more choice sets. This finding supports the Discovered Preference Hypothesis interpretation and explanation of starting point bias....

77 FR 41431 - Proposed Collection; Comment Request: Impact of Clinical Research Training and Medical Education...

Science.gov (United States)

2012-07-13

... Request: Impact of Clinical Research Training and Medical Education at the Clinical Center on Physician Careers in Academia and Clinical Research SUMMARY: In compliance with the requirement of Section 3506(c)(2... approval. Proposed Collection Title: The Impact of Clinical Research Training and Medical Education at the...

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...

The need for patient-centred clinical research in idiopathic pulmonary fibrosis.

Science.gov (United States)

Russell, Anne-Marie; Sprangers, Mirjam A G; Wibberley, Steven; Snell, Noel; Rose, Daniel M; Swigris, Jeff J

2015-09-24

Patient-centredness is an accepted term and is perceived by healthcare professionals to be morally and ethically desirable. We are motivated by the belief that this approach will improve the patient-professional experience of the decision-making process and improve health outcomes. We acknowledge that patients, either as participants or as co-investigators, have positive contributions to make to research. As the idiopathic pulmonary fibrosis (IPF) community enters a new era of clinical research activity we consider that there is greater capacity for patient involvement and partnership.Patient involvement in research can be optimised through collaborations in the research design, study conduct, and dissemination. There is increasing interest in using patient- reported outcomes (PROs), such as health-related quality of life, and symptoms measures to inform decision-making and ensure patient perspectives are taken into account. PROs are an essential component of specialist IPF services, to monitor and improve care delivery and to measure and benchmark performance. In clinical trials, PROs can additionally be used to define entry criteria, evaluate efficacy of an intervention, and evaluate adverse events. We suggest that there is a much wider scope for including patient-centred PROs in clinical research and for creative thought in developing patient co-investigator roles.Participation in research activity requires highly refined decision-making processes, particularly in a condition such as IPF, which has an often unpredictable trajectory. The IPF research landscape has changed and the design and conduct of clinical trials in IPF requires some radical rethinking. It is accepted that involving patients in the role of co-investigators will impact the research questions we ask and result in study designs that are patient-centred. IPF clinical trials have been hindered by the lack of availability of validated, disease-specific questionnaires. A conservative approach

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

How Can a Clinical Research Approach Contribute to Knowledge-Building for the Teaching Profession?

Science.gov (United States)

Bulterman-Bos, Jacquelien

2017-01-01

This article explains what clinical research is and why it is necessary. The term "clinical" refers to an academic way of solving practical problems. Clinical research starts from a view of science that not only acknowledges the value of rational analysis and empirical research, but also acknowledges the need for human skills and…

Unique roles of SPET brain imaging in clinical and research studies

International Nuclear Information System (INIS)

Seibyl, J.; Jennings, D.; Tabamo, R.; Marek, K.

2005-01-01

The increasing availability of PET imaging in Nuclear medicine expands the armamentarium of clinical and research tools for improving diagnosis and treatment of neuropsychiatric disorders. Nonetheless, the role of SPEC imaging remains critical to both research and clinical practice. The development of rational strategies for guiding the selection of imaging modalities flows from primarily the nature of the clinical or research question and the availability of appropriate radiopharmaceuticals. There has been extensive SPECT and PET work in Parkinson's disease (PD) which highlights the value of both these scintigraphic modalities. Three main areas of interest in PD include imaging for improving diagnostic accuracy, for monitoring the progression of disease, and for assessing the therapeutic efficacy of drugs with neoroprotective potential. The demands of the clinical or research question posed to imaging dictates the selection of radiotracer and imaging modality. Diagnosis of PD represents the easiest challenge with many imaging bio markers showing high sensitivity for detecting abnormal reduction of dopaminergic function based on qualitative review of images. On the other hand, using imaging to evaluate treatments which purportedly slow the rate of disease progression, indicated by the reduction of the rate of loss in a quantitative imaging signal in patients studied over time, represents the most rigorous requirement of the imaging measure. In each of these applications presynaptic markers of dopaminergic function using SPECT and PET have been extremely valuable. Review of neuroimaging studies of PD provides a useful example of optimized approaches to clinical and research studies in neuropsychiatric disorders

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

Project Stakeholder Management in the clinical research environment: how to do it right.

Directory of Open Access Journals (Sweden)

Seithikurippu R. Pandi-Perumal

2015-05-01

Full Text Available This review introduces a conceptual framework for understanding stakeholder management in the clinical and community-based research environment. In recent years, an evolution in practice has occurred in which many applicants for public and non-governmental funding of public health research in hospital settings. Community health research projects are inherently complex, have sought to involve patients and other stakeholders in the center of the research process. Substantial evidence has now been provided that stakeholder involvement is essential for management effectiveness in clinical research. Feedback from stakeholders has critical value for research managers inasmuch as it alerts them to the social, environmental and ethical implications of research activities. Additionally those who are directly affected by program development and clinical research, the patients, their families, and others, almost universally have a strong motivation to be involved in the planning and execution of new program changes. The current overview introduces a conceptual framework for stakeholder management in the clinical research environment and offers practical suggestions for fostering meaningful stakeholder engagement. The fifth edition of PMBOK® of the Project Management Institute (PMI, has served as basis for many of the suggested guidelines that are put forward in this article.

Project Stakeholder Management in the Clinical Research Environment: How to Do it Right

Science.gov (United States)

Pandi-Perumal, Seithikurippu R.; Akhter, Sohel; Zizi, Ferdinard; Jean-Louis, Girardin; Ramasubramanian, Chellamuthu; Edward Freeman, R.; Narasimhan, Meera

2015-01-01

This review introduces a conceptual framework for understanding stakeholder management (ShM) in the clinical and community-based research environment. In recent years, an evolution in practice has occurred in many applicants for public and non-governmental funding of public health research in hospital settings. Community health research projects are inherently complex, have sought to involve patients and other stakeholders in the center of the research process. Substantial evidence has now been provided that stakeholder involvement is essential for management effectiveness in clinical research. Feedback from stakeholders has critical value for research managers inasmuch as it alerts them to the social, environmental, and ethical implications of research activities. Additionally, those who are directly affected by program development and clinical research, the patients, their families, and others, almost universally have a strong motivation to be involved in the planning and execution of new program changes. The current overview introduces a conceptual framework for ShM in the clinical research environment and offers practical suggestions for fostering meaningful stakeholder engagement. The fifth edition of PMBOK® of the Project Management Institute, has served as basis for many of the suggested guidelines that are put forward in this article. PMID:26042053

Project Stakeholder Management in the Clinical Research Environment: How to Do it Right.

Science.gov (United States)

Pandi-Perumal, Seithikurippu R; Akhter, Sohel; Zizi, Ferdinard; Jean-Louis, Girardin; Ramasubramanian, Chellamuthu; Edward Freeman, R; Narasimhan, Meera

2015-01-01

This review introduces a conceptual framework for understanding stakeholder management (ShM) in the clinical and community-based research environment. In recent years, an evolution in practice has occurred in many applicants for public and non-governmental funding of public health research in hospital settings. Community health research projects are inherently complex, have sought to involve patients and other stakeholders in the center of the research process. Substantial evidence has now been provided that stakeholder involvement is essential for management effectiveness in clinical research. Feedback from stakeholders has critical value for research managers inasmuch as it alerts them to the social, environmental, and ethical implications of research activities. Additionally, those who are directly affected by program development and clinical research, the patients, their families, and others, almost universally have a strong motivation to be involved in the planning and execution of new program changes. The current overview introduces a conceptual framework for ShM in the clinical research environment and offers practical suggestions for fostering meaningful stakeholder engagement. The fifth edition of PMBOK(®) of the Project Management Institute, has served as basis for many of the suggested guidelines that are put forward in this article.

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.

Minimum reporting standards for clinical research on groin pain in athletes

DEFF Research Database (Denmark)

Delahunt, Eamonn; Thorborg, Kristian; Khan, Karim M

2015-01-01

Groin pain in athletes is a priority area for sports physiotherapy and sports medicine research. Heterogeneous studies with low methodological quality dominate research related to groin pain in athletes. Low-quality studies undermine the external validity of research findings and limit the ability...... to generalise findings to the target patient population. Minimum reporting standards for research on groin pain in athletes are overdue. We propose a set of minimum reporting standards based on best available evidence to be utilised in future research on groin pain in athletes. Minimum reporting standards...... are provided in relation to: (1) study methodology, (2) study participants and injury history, (3) clinical examination, (4) clinical assessment and (5) radiology. Adherence to these minimum reporting standards will strengthen the quality and transparency of research conducted on groin pain in athletes...

Mary Ellen Avery’s Research Career- Remembrance of Things Past

Directory of Open Access Journals (Sweden)

John Steven Torday

2014-04-01

Full Text Available Mary Ellen Avery’s research is recognized as a milestone in biomedical research. She had discovered the underlying cause of Hyaline Membrane Disease, surfactant deficiency, fostering ever more vigorous efforts to reduce neonatal mortality in the burgeoning practice of Neonatology. Neonatology is the only clinical discipline that began as an experiment, making it a model for biomedical research. Avery knew that the concerted effort to treat preterm newborns could potentially do more harm than good, violating her oath to Hippocrates, if not held to the highest scientific standards. She remained true to that pledge throughout her career, as recounted in this Review.

Pre-clinical research in small animals using radiotherapy technology. A bidirectional translational approach

International Nuclear Information System (INIS)

Tillner, Falk; Buetof, Rebecca; Krause, Mechthild; Enghardt, Wolfgang; Helmholtz-Zentrum Dresden-Rossendorf, Dresden; Technische Univ. Dresden; Helmholtz-Zentrum Dresden-Rossendorf, Dresden

2014-01-01

For translational cancer research, pre-clinical in-vivo studies using small animals have become indispensable in bridging the gap between in-vitro cell experiments and clinical implementation. When setting up such small animal experiments, various biological, technical and methodical aspects have to be considered. In this work we present a comprehensive topical review based on relevant publications on irradiation techniques used for pre-clinical cancer research in mice and rats. Clinical radiotherapy treatment devices for the application of external beam radiotherapy and brachytherapy as well as dedicated research irradiation devices are feasible for small animal irradiation depending on the animal model and the experimental goals. In this work, appropriate solutions for the technological transfer of human radiation oncology to small animal radiation research are summarised. Additionally, important information concerning the experimental design is provided such that reliable and clinically relevant results can be attained.

Pre-clinical research in small animals using radiotherapy technology. A bidirectional translational approach

Energy Technology Data Exchange (ETDEWEB)

Tillner, Falk; Buetof, Rebecca [Technische Univ. Dresden (Germany). OncoRay - National Center for Radiation Research in Oncology; Helmholtz-Zentrum Dresden-Rossendorf, Dresden (Germany); Technische Univ. Dresden (Germany). Dept. of Radiation Oncology; Thute, Prasad [Technische Univ. Dresden (Germany). OncoRay - National Center for Radiation Research in Oncology; Helmholtz-Zentrum Dresden-Rossendorf, Dresden (Germany); Krause, Mechthild [Technische Univ. Dresden (Germany). OncoRay - National Center for Radiation Research in Oncology; Helmholtz-Zentrum Dresden-Rossendorf, Dresden (Germany); Technische Univ. Dresden (Germany). Dept. of Radiation Oncology; German Cancer Consortium (DKTK), Dresden (Germany); German Cancer Research Center (DKFZ), Heidelberg (Germany); Enghardt, Wolfgang [Technische Univ. Dresden (Germany). OncoRay - National Center for Radiation Research in Oncology; Helmholtz-Zentrum Dresden-Rossendorf, Dresden (Germany); Technische Univ. Dresden (Germany). Dept. of Radiation Oncology; Helmholtz-Zentrum Dresden-Rossendorf, Dresden (Germany). Inst. of Radiooncology

2014-07-01

For translational cancer research, pre-clinical in-vivo studies using small animals have become indispensable in bridging the gap between in-vitro cell experiments and clinical implementation. When setting up such small animal experiments, various biological, technical and methodical aspects have to be considered. In this work we present a comprehensive topical review based on relevant publications on irradiation techniques used for pre-clinical cancer research in mice and rats. Clinical radiotherapy treatment devices for the application of external beam radiotherapy and brachytherapy as well as dedicated research irradiation devices are feasible for small animal irradiation depending on the animal model and the experimental goals. In this work, appropriate solutions for the technological transfer of human radiation oncology to small animal radiation research are summarised. Additionally, important information concerning the experimental design is provided such that reliable and clinically relevant results can be attained.

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

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

Retention of minority participants in clinical research studies.

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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.

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...

[Methodology for clinical research in Orthodontics, the assets of the beOrtho website].

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Ruiz, Martial; Thibult, François

2014-06-01

The rules applying to the "evidence-based" methodology strongly influenced the clinical research in orthodontics. However, the implementation of clinical studies requires rigour, important statistical and methodological knowledge, as well as a reliable environment in order to compile and store the data obtained from research. We developed the project "beOrtho.com" (based on orthodontic evidence) in order to fill up the gap between our desire to drive clinical research and the necessity of methodological rigour in the exploitation of its results. BeOrtho website was created to answer the issue of sample recruitment, data compilation and storage, while providing help for the methodological design of clinical studies. It allows the development and monitoring of clinical studies, as well as the creation of databases. On the other hand, we designed an evaluation grid for clinical studies which helps developing systematic reviews. In order to illustrate our point, we tested a research protocol evaluating the interest of the mandibular advancement in the framework of Class II treatment. © EDP Sciences, SFODF, 2014.

Clinical research of traditional Chinese medicine in big data era.

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Zhang, Junhua; Zhang, Boli