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  1. Trial by jury in the United States

    Directory of Open Access Journals (Sweden)

    Lochhead Robert

    2015-10-01

    Full Text Available Th e Republic of Moldova is considering the adoption of trial by jury in select criminal cases. Th e following article is intended to contribute to the discussion of that proposal. Th e article will briefl y describe the history of juries under the English common law and as adopted by the United States. It will then outline some of the basic procedures in trials by jury as currently practiced in the United States federal court system.

  2. Trial by Jury in Russian Military Courts

    Directory of Open Access Journals (Sweden)

    Nikolai P. Kovalev

    2008-07-01

    Full Text Available One of peculiar features of the military criminal justice system in Russia is that in some cases military defendants may apply for trial by jury. Unlike the existing U.S. court-martial jury and the Russian military jury of the early 1900s (World War I period which were comprised of the members of the armed forces, in modern Russia jurors trying military defendants are civilians. This article aims to provide a brief history of military jury in Russia and identify issues of independence and impartiality in Russian military courts with participation of lay decision-makers. In particular, the article will analyze two high-profile cases which resulted in acquittals of Russian officers accused of killing several Chechen civilians during counter-terrorist operations in Chechnya.

  3. The effects of jury size, evidence complexity, and note taking on jury process and performance in a civil trial.

    Science.gov (United States)

    Horowitz, Irwin A; Bordens, Kenneth S

    2002-02-01

    A total of 567 jury-eligible men and women who were assigned to 6- or 12-person juries saw a videotaped civil trial that contained either I or 4 plaintiffs. Half the juries took notes, whereas the remainder did not. Six-person juries that did not take notes awarded multiple plaintiffs the highest amounts of compensation. Six-person juries also gave the highest punitive damages when they did not take notes and judged multiple plaintiffs. The punitive awards of 6-person juries were highly variable compared with 12-person juries. Multiple plaintiffs also increased the unpredictability of jury punitive awards. Twelve-person juries deliberated longer, recalled more probative information, and relied less than 6-person juries on evaluative statements and nonprobative evidence. Limitations and implications are discussed.

  4. Jury selection and jury trial in Spain: between theory and practice

    Directory of Open Access Journals (Sweden)

    Mar Jimeno-Bulnes

    2011-12-01

    Full Text Available The Jury Court in Spain is composed of nine citizens and is headed by a magistrate belonging to the Provincial Court, Chamber of Criminal. These citizens participate as lay assessors in a very particular way. The Spanish Jury Law 5/1995 contemplates its intervention in criminal proceedings as a sort of ‘duty-right’; one hand, inasmuch as it is a right, the law guarantees a remuneration; on the other, inasmuch as it is a duty, the Jury Law does not provide any sort of sanction because of inassistance. Also legal status of the Spanish jurors is established by a complicated system of qualification and disqualifications causes. There are four categories for disqualification: incapacities, incompatibilities, prohibitions and excuses, which contemplate various personal and professional circumstances. In contrast, certain omissions in the regulation may be appreciated such as the conscientious objection for example, which becomes the most controversial question with regard to the duty to act as a juror.The purpose of present paper is to discuss the abover points and examines how jury selection and service actually proceeds in Spanish Jury Courts. An initial reference is made to the composition of the lists of prospective jurors, which includes an explanation of the way in which prospective jurors are designated by random from the electoral census and how the definitive lists are drawn up in each province at two-yearly intervals and delivered to the Provincial Courts. Subsequently, the trial jury selection system is presented along with other measures that relate to jury participation in criminal proceedings, such as the completion of a questionnaire on lawful grounds for disqualification and the distribution of a copy of the ‘jury handbook’ to each selected juror. References are also made to the possibility of challenges for cause and without cause (peremptory challenges both by the parties to the trial, defence and prosecution, as well as to

  5. When Justice Is Up to You. Celebrating America's Guarantee of Trial by Jury.

    Science.gov (United States)

    National Inst. for Citizen Education in the Law, Washington, DC.

    Featuring a mock trial tested in the District of Columbia, the objective of this manual is to help students learn more about the constitutional guarantee of trial by jury. Prepared as five separate lessons, the manual examines one alternative to the jury system--trial by ordeal; traces the development of the guarantee of trial by jury; explores…

  6. Origin of a Jury Trial in the European Countries

    Directory of Open Access Journals (Sweden)

    Radik N. Hamitov

    2017-11-01

    Full Text Available Traditionally it is believed that the birthplace of the jury trial creation is England, but the issue of the birthplace location of this particular form of popular participation in the criminal justice administration is not yet fully resolved by the historical science. The continental lawyers were particularly interested in the jury trial among other institutions of English law, in which the English themselves identified the stronghold of the country's law and order, its political and civil freedom. It is not difficult to see that the main role was not played by the judges, but by the community representatives in this form of justice administration. Since then the community has been gaining more and more importance in England as a state body in the matter of justice administration, and the initial forms of its activity have being further developed in this direction. This works investigates roots of jury trial by basing on such methods as historical, systemic, formally logical, concrete-historical, comparative legal analysis method.­ The authors, in turn, come to the conclusion that the jury trial has its roots still in the Ancient States, but the classical modern model owes its origin to England.

  7. The verdict on jury trials for juveniles: the effects of defendant's age on trial outcomes.

    Science.gov (United States)

    Warling, Diane; Peterson-Badali, Michele

    2003-01-01

    With the progression to more adult-like policies and procedures for youth in the justice system, the right to a jury trial has been extended to young offenders. These youth would not be tried by a jury of their peers, however, but by a jury of adults. The concern is that adult jurors may hold negative attitudes about youth that might influence their decision making in a case involving a young defendant. Two studies examined whether and under what conditions defendant's age affects jurors' decisions about the guilt and sentencing of an accused. In study 1, data were gathered from two samples of jury eligible adults: one university sample and one public sample. Mock jurors read written transcripts of a trial involving a defendant who was presented as either 13, 17, or 25 years of age. Results indicated that the defendant's age had no effect on mock jurors' verdict or their ratings of defendant guilt. However, younger defendants were granted shorter sentences than the adult defendants. In study 2, mock jurors read the same trial presented in study 1 but were asked to deliberate about the case and render group verdicts. These group verdicts did not differ significantly by defendant's age. Age-related themes that emerged from group deliberations were identified, and results indicated that age tended to be used as a mitigating factor in favor of youth rather than against them. These findings are discussed in terms of their implications for youth justice policy and practice. Copyright 2003 John Wiley & Sons, Ltd.

  8. Trials by Juries: Suggested Practices for Database Trials

    Science.gov (United States)

    Ritterbush, Jon

    2012-01-01

    Librarians frequently utilize product trials to assess the content and usability of a database prior to committing funds to a new subscription or purchase. At the 2012 Electronic Resources and Libraries Conference in Austin, Texas, three librarians presented a panel discussion on their institutions' policies and practices regarding database…

  9. Goffman on the jury: real jurors' attention to the "offstage" of trials.

    Science.gov (United States)

    Rose, Mary R; Diamond, Shari Seidman; Baker, Kimberly M

    2010-08-01

    Social psychologist Erving Goffman, in his classic work The Presentation of Self in Everyday Life, provides a framework that explains why jurors may turn their attention at the courthouse to information not formally presented from the witness stand. We dub this "offstage observation," a type of juror behavior that has not been systematically examined empirically. Analyzing a unique data source of 50 actual jury deliberations in civil trials, we find that jurors do look to the offstage in evaluating the claims of the parties. However, in contrast to predictions, these observations played a surprisingly minor role in the jury deliberation process.

  10. FREEDOM OF PRESS AND JURY TRIAL IN ISTRIA 1848/1849

    Directory of Open Access Journals (Sweden)

    Dunja Pastović

    2015-01-01

    Full Text Available In Istria, as a part of the Austrian legal system, jury trial was initially introduced in the revolutionary year of 1848 only for press offenses, in the framework of aspirations for freedom of thought and expression through the press, which represented the most appropriate medium for the dissemination of new ideas and mobilization of the political masses. Trial by jury was supposed to secure impartial and objective trials, which could not be expected of professional judges due to insufficient guarantees of their impartiality. This paper examines the press-related orders and laws passed during 1848 and 1849 which regulated the freedom of press and jury jurisdiction. On the basis of an analysis of the legislative framework, jurisprudence, and the Istrian press during the examined time period, the author has decided that the introduction of the freedom of the press and jury trials for press offenses in 1848/1849 on the territory of Istria didn’t have a large practical significance.

  11. Court grants courier a jury trial based on fear of AIDS.

    Science.gov (United States)

    1996-03-08

    A medical courier who was exposed to blood from a leaking container will be granted a jury trial in Albuquerque, NM. Courier [name removed] was splashed with blood and became alarmed because she had paper cuts on her hands. Repeated blood tests for HIV and hepatitis B were negative. A Bernallilo County judge initially dismissed [name removed]'s lawsuit when the hospital revealed that there was no HIV present in the splashed liquid. A three-judge panel of the Court of Appeals ruled to allow [name removed] a jury trial because New Mexico law no longer requires a plaintiff to prove that the defendant's actions created actual danger or physical impact. The panel determined that [name removed]'s allegations stated a cause for negligent infliction of emotional distress.

  12. Crime and Punishment: the Impact of Skin Color and Socioeconomic Status of Defendants and Victims in Jury Trials in Brazil.

    Science.gov (United States)

    da Silva, Rogério Ferreira; Oliveira Lima, Marcus Eugênio

    2016-11-14

    Social judgments are often influenced by racism. Voluntary crimes against life, and in particular the crime of homicide, may be the most critical situations of the impact of racism in social judgments. We analyzed 114 homicide trials conducted by the 1st Jury Court, in a Brazilian judicial capital, concluded between 2003 and 2007, for the purpose of investigating the effects of skin color and the socioeconomic status of the defendant and the victim of homicides in the jury trial court's decision. The results indicate that the social and economic profile of defendants and victims of homicide is identical. They are almost all poor (more than 70%), with low education (more than 73%) and frequently non-Whites (more than 88%). We found that judges assign longer sentences to black (β = .34, p = .01) and poor defendants (β = .23, p socioeconomic status in social judgments and in discrimination.

  13. Juris International

    CERN Document Server

    A database on international trade law aimed at lawyers and legal counsel in developing and transition economies. Juris International is a multilingual collection (English, Spanish, and French) of legal information on international trade. Juris International aims to facilitate and reduce the work involved in research for business lawyers, advisers and in-house counsel, and state organizations in developing nd transition economies, by providing access to texts which have often been difficult to obtain. Its objective is to gather a large quantity of basic information at one site (favoring complete legal texts), without the need to send for the information, and consequently without excessive communication costs for users who d benefit from an efficient and cheap telecommunications network.

  14. [Psychiatry and criminology in Criminal Justice: Jury Trial Courts and Appellate Courts in the Federal District of Rio de Janeiro, during the 1930s].

    Science.gov (United States)

    Dias, Allister Andrew Teixeira

    2015-01-01

    As part of a research study on the 1930s and 1940s medical-criminological debate in Brazil, this research paper analyzes some of the uses and criticisms of arguments of a psychiatric and criminological nature, among certain jurists who carried out important work in the city of Rio de Janeiro during the 1930s. In this context, these magistrates, tended to have significant psychiatric and criminological knowledge, in spite of all the heterogeneity, plurality and differences in perspectives that existed among them. We selected two principal areas to conduct an analysis of the activities of these jurists: the Appellate Court of the Federal District of Rio de Janeiro and Jury Trial Courts.

  15. The Invention of the Jury in " The Auto Mary " by Ariano Suassuna

    Directory of Open Access Journals (Sweden)

    Ezilda Claudia de Melo

    2016-06-01

    Full Text Available It identified the intersections between the jury and literature , the "Auto da Compadecida " Ariano Suassuna . He embarked at the intersection field between law and Literary Arts to identify the characters, ritual and emotion in the jury of the show presented by him . The trial is the real key to understanding this work and is the intersection point of this research, with the law as it is intended to relate the institution of the jury from the buildings Ariano Suassuna . It was concluded that emotionality gives on the rationality of the jury.

  16. Silmapaistev Juri Lotmani ja Zara Mintsi arhiiv

    Index Scriptorium Estoniae

    2007-01-01

    Tallinna Ülikoolis paikneb rahvusvaheliselt tunnustatud semiootiku Juri Lotmani ja tema abikaasa Zara Mintsi arhiiv ja raamatukogu. Juri Lotmani poeg ja Tallinna Ülikooli Eesti Humanitaarinstituudi professor Mihhail Lotman on rahul, et arhiiv asub Eestis

  17. JurisLIT Final Report.

    Science.gov (United States)

    Sacramento County Probation Dept., Sacramento, CA.

    JurisLIT was a literacy training effort operated jointly by the Sacramento County Probation Department, the Sacramento County Office of Education, the Los Rios Community College District, and the Superior and Municipal Courts of Sacramento County from March 1990 to March 1994. The program required selected probationers aged 18-30 to participate in…

  18. Blinded by the White: A Comparative Analysis of Jury Challenges on Racial Grounds

    Directory of Open Access Journals (Sweden)

    Thalia Anthony

    2017-08-01

    Full Text Available Indigenous peoples in Australia, the United States and Canada are significantly overrepresented as defendants in criminal trials and yet vastly underrepresented on juries in criminal trials. This means that all-white juries mostly determine the guilt of Indigenous defendants or white defendants responsible for harming Indigenous victims. In this article, we explore cases in which Indigenous defendants have perceived that an all-white jury’s prejudice against Indigenous people would prevent them receiving a fair trial. It focuses on Indigenous defendants (often facing charges in relation to protesting against white racism challenging the array of all-white juries. Across these cases, Australian courts rely on formal notions of fairness in jury selection to dismiss the Indigenous defendant’s perception of bias and foreclose an inquiry into the potential prejudices of white jurors. We compare the Australian judicial ‘colour-blindness’ towards all-white juries with that of the United States and Canada. We argue that the tendency for courts in the United States and Canada to question jurors on their biases provides useful lessons for Australian judiciaries, including in relation to the impending trials of Indigenous defendants in Kalgoorlie, Western Australia, accused of committing crimes in response to white racist violence. Nonetheless, across all jurisdictions where there is a challenge to the array based on racial composition, courts consistently uphold all-white juries. We suggest that the judicial view of the racial neutrality of white jury selection misapprehends the substantive biases in jury selection and the injustice perceived by defendants in having a white jury adjudicate an alleged crime that is committed in circumstances involving protest against white prejudice.

  19. Juri Jerjomini lavastused suvel Tallinnas / Andres Laasik

    Index Scriptorium Estoniae

    Laasik, Andres, 1960-2016

    2006-01-01

    5.-7. juulini mängitakse Estonia teatris Mossoveti teatris valminud Juri Jerjomini lavastusi - Fjodor Dostojevski ja Ivan Turgenevi teoste põhjal "Mees, naine ja armuke" ja Tennessee Williamsi "Tramm nimega iha"

  20. How should we go about jury research in Scotland?

    OpenAIRE

    Chalmers, James; Leverick, Fiona

    2016-01-01

    Considers why jury research is needed in Scotland, and the methods that could be used. Discusses the justifications for research into jury reasoning and decision-making advanced by the Post-Corroboration Safeguards Review, and its proposals on issues such as simple majority verdicts. Examines options for research with real or mock juries, the possible research questions, and whether reform of the Contempt of Court Act 1981 would be necessary.

  1. Juri Jerjomin : teatr dolzhen bõt derzkim / Juri Jerjomin ; interv. Boris Tuch

    Index Scriptorium Estoniae

    Jerjomin, Juri

    2006-01-01

    5.-7. juulini toimuvad Estonia teatris Moskva Mossoveti-nim. Teatri külalisetendused. Mängitakse Juri Jerjomini lavastusi "Mees, naine ja armuke" (F. Dostojevski ja I. Turgenevi teoste põhjal) ja Tennessee Williamsi "Tramm nimega Iha". Vestluses lavastajaga ka vene teatrist, arengust, näitekirjanikest, lavastustest

  2. Einstein's Jury The Race to Test Relativity

    CERN Document Server

    Crelinsten, Jeffrey

    2006-01-01

    Einstein's Jury is the dramatic story of how astronomers in Germany, England, and America competed to test Einstein's developing theory of relativity. Weaving a rich narrative based on extensive archival research, Jeffrey Crelinsten shows how these early scientific debates shaped cultural attitudes we hold today. The book examines Einstein's theory of general relativity through the eyes of astronomers, many of whom were not convinced of the legitimacy of Einstein's startling breakthrough. These were individuals with international reputations to uphold and benefactors and shareholders to p

  3. How Juries Assess Universal Design in Norwegian Architectural School Competitions.

    Science.gov (United States)

    Houck, Leif D

    2016-01-01

    This paper investigates how architectural school competition juries assess Universal Design. The method used is a case study of 18 recent architectural school competitions in Norway. The results show that most competition briefs ask for Universal Designed buildings. In 8 of the 18 cases, Universal Design is mentioned as an assessment criterion. In 11 of the 18 cases, Universal Design is commented on by the juries in the jury reports, but only in 3 of the cases, do the juries assess this aspect consistently on every competition project. The overall impression is that some amount of uncertainty looms concerning how Universal Design should be assessed in the competition stage. Based on the findings, future juries should concentrate on orientation and overview prior to technicalities and details.

  4. Defendants' Rights in Criminal Trials.

    Science.gov (United States)

    Martin, Ralph C., II; Keeley, Elizabeth

    1997-01-01

    Reviews the protections afforded by the Constitution for defendants in criminal trials. These include the right to a jury trial (in cases of possible incarceration), an impartial jury, and the requirement of a unanimous verdict. Defends the use of plea bargaining as essential to an efficient criminal justice system. (MJP)

  5. Einstein's Jury: The Race to Test Relativity

    International Nuclear Information System (INIS)

    Ehlers, Juergen

    2007-01-01

    'I know very well that my theory rests on a shaky foundation. What attracts me to it is that it leads to consequences that seem to be accessible to experiment, and it provides a starting point for the theoretical understanding of gravitation', wrote Einstein in 1911. Einstein's Jury by Jeffrey Crelinsten-well documented, well written, and fascinating to read-describes how, from 1909 on, Einstein's two theories of relativity became known to astronomers, and how the predictions made between 1907 and 1915 were received as challenges to observers. The author gives a non-technical account of the efforts made until 1930 to test these predictions; he focuses on two of the three classical tests, namely gravitational redshift and bending of light; the 'jury' consists mainly of American observers-Adams, Campbell, Curtis, Hale, Perrin, St John, Trumpler and others-working with newly built large telescopes, and the Britons Eddington and Evershed. The major steps which, after a long struggle, convinced the majority of astronomers that Einstein was right, are narrated chronologically in rather great detail, especially the work at Lick Observatory, before and after the famous British observation of 1919, on solar eclipses, and the work at Mount Wilson and the Indian Kodaikanal Observatories to extract the gravitational redshift from the complicated spectrum of the sun. The account of the eclipse work which was carried out between 1918 and 1923 by Lick astronomers corrects the impression suggested by many historical accounts that the British expedition alone settled the light-bending question. Apart from these main topics, the anomalous perihelion advance of Mercury and the ether problem are covered. By concentrating on astronomy rather than on physics this book complements the rich but repetitive literature on Einstein and relativity which appeared in connection with the commemoration of Einstein's annus mirabilis, 2005. The well told stories include curiosities such as the

  6. PlanJury: probabilistic plan evaluation revisited

    Science.gov (United States)

    Witte, M.; Sonke, J.-J.; van Herk, M.

    2014-03-01

    Purpose: Over a decade ago, the 'Van Herk margin recipe paper' introduced plan evaluation through DVH statistics based on population distributions of systematic and random errors. We extended this work for structures with correlated uncertainties (e.g. lymph nodes or parotid glands), and considered treatment plans containing multiple (overlapping) dose distributions (e.g. conventional lymph node and hypo-fractionated tumor doses) for which different image guidance protocols may lead to correlated errors. Methods: A command-line software tool 'PlanJury' was developed which reads 3D dose and structure data exported from a treatment planning system. Uncertainties are specified by standard deviations and correlation coefficients. Parameters control the DVH statistics to be computed: e.g. the probability of reaching a DVH constraint, or the dose absorbed at given confidence in a (combined) volume. Code was written in C++ and parallelized using OpenMP. Testing geometries were constructed using idealized spherical volumes and dose distributions. Results: Negligible stochastic noise could be attained within two minutes computation time for a single target. The confidence to properly cover both of two targets was 90% for two synchronously moving targets, but decreased by 7% if the targets moved independently. For two partially covered organs at risk the confidence of at least one organ below the mean dose threshold was 40% for synchronous motion, 36% for uncorrelated motion, but only 20% for either of the organs separately. Two abutting dose distributions ensuring 91% confidence of proper target dose for correlated motions led to 28% lower confidence for uncorrelated motions as relative displacements between the doses resulted in cold spots near the target. Conclusions: Probabilistic plan evaluation can efficiently be performed for complicated treatment planning situations, thus providing important plan quality information unavailable in conventional PTV based evaluations.

  7. How ordinary judges and juries decide the seemingly complex technological questions of patentability over the prior art.

    Science.gov (United States)

    Kieff, F Scott

    2003-01-01

    Determinations of patentability over the prior art are often thought to raise questions that are so technologically complex that they require special training and judgment to answer, especially in fast-moving fields like modern biotechnology. This essay explores the somewhat counterintuitive argument that under the U.S. system they do not and should not. According to this view, determinations of patentability over the prior art are based entirely on factual inquiries that are best made by lay judges and juries, just like the factual determinations these people regularly make in any ordinary nonpatent trial. This is good because judges and juries are adept at these determinations, and because appellate courts are adept at reviewing them. It leads to a system that is cheaper overall in allowing private litigants to better predict outcomes that also better approximate the correct answer than would be possible under other regimes premised upon the expert technological knowledge and judgment of a decisionmaker.

  8. Investigating Comprehension in Real World Tasks: Understanding Jury Instructions.

    Science.gov (United States)

    Charrow, Veda R.; Charrow, Robert

    This paper discusses the results of part of an ongoing project studying an aspect of real world language usage, the comprehension of standard jury instructions. Problems in the comprehension of these instructions include the memory load that they impose, the fact that most instructions are read only once, and the fact that instructions are written…

  9. Juri Lotman Püha Graali otsinguil / L. G. C.

    Index Scriptorium Estoniae

    L. G. C.

    2008-01-01

    Dokumentaalfilm semiootik Juri Lotmanist (1922-1993) "Lotmani maailm" : stsenaristid Agne Nelk, Rein Pakk : režissöör A. Nelk : produtsent Kiur Aarma : animatsioon Rait Siska : Ruut, 2008. Autoriks L. G. C. - Leonard Gaius Cohen e. Lemmit Kaplinski

  10. Statistical Outlier Detection for Jury Based Grading Systems

    DEFF Research Database (Denmark)

    Thompson, Mary Kathryn; Clemmensen, Line Katrine Harder; Rosas, Harvey

    2013-01-01

    This paper presents an algorithm that was developed to identify statistical outliers from the scores of grading jury members in a large project-based first year design course. The background and requirements for the outlier detection system are presented. The outlier detection algorithm...... and the follow-up procedures for score validation and appeals are described in detail. Finally, the impact of various elements of the outlier detection algorithm, their interactions, and the sensitivity of their numerical values are investigated. It is shown that the difference in the mean score produced...... by a grading jury before and after a suspected outlier is removed from the mean is the single most effective criterion for identifying potential outliers but that all of the criteria included in the algorithm have an effect on the outlier detection process....

  11. A trap for the unwary: jury decision making in cases involving the entrapment defense.

    Science.gov (United States)

    Peters, Christopher S; Lampinen, James Michael; Malesky, L Alvin

    2013-02-01

    This article examines the opinions of jury-eligible participants regarding entrapment-related issues in online sex offender sting operations. Participants provided lower guilt ratings when the undercover officer initiated the online sexual solicitation than when the defendant initiated the online sexual solicitation. This effect was mediated by the causal attributions (situational vs. dispositional) made by mock jurors for the defendant's actions. The results also suggested that the entrapment defense was less successful for participants with a crime control orientation than for participants with a due process orientation. Based on the results, it is implied that law enforcement should exercise caution when performing these types of sting operations. Furthermore, defense and prosecuting attorneys should take into account the originators of the sexual solicitation when deciding whether to plea bargain or take a case to trial.

  12. Probability of criminal acts of violence: a test of jury predictive accuracy.

    Science.gov (United States)

    Reidy, Thomas J; Sorensen, Jon R; Cunningham, Mark D

    2013-01-01

    The ability of capital juries to accurately predict future prison violence at the sentencing phase of aggravated murder trials was examined through retrospective review of the disciplinary records of 115 male inmates sentenced to either life (n = 65) or death (n = 50) in Oregon from 1985 through 2008, with a mean post-conviction time at risk of 15.3 years. Violent prison behavior was completely unrelated to predictions made by capital jurors, with bidirectional accuracy simply reflecting the base rate of assaultive misconduct in the group. Rejection of the special issue predicting future violence enjoyed 90% accuracy. Conversely, predictions that future violence was probable had 90% error rates. More than 90% of the assaultive rule violations committed by these offenders resulted in no harm or only minor injuries. Copyright © 2013 John Wiley & Sons, Ltd.

  13. Juri Lotmani kunstiteksti lugemise õpetus / Ülle Pärli

    Index Scriptorium Estoniae

    Pärli, Ülle

    2007-01-01

    Ilukirjanduslike tekstide kasutamisest vene keele õpetamisel. Kirjandusteksti analüüsi põhimõtetest Juri Lotmani monograafiates. Lotmani osalusel koostatud kirjandusõpikutest ja kirjanduslikust lugemikust

  14. Using Pretest-Posttest Research Designs to Enhance Jury Decision-Making

    Directory of Open Access Journals (Sweden)

    Jane Goodman-Delahunty

    2016-06-01

    Full Text Available When lay jurors are unfamiliar with key evidentiary issues, expert evidence, judicial instructions and group deliberation may enhance their understanding of this evidence. Systematic steps to assess the relationship between juror biases in cases of child sexual abuse are offered as an example to illustrate a programmatic research approach. Using pretest-posttest research designs, the effectiveness of three traditional legal procedural safeguards to reduce common jury misconceptions in the context of simulated trials were tested and compared. By measuring mock-juror knowledge before and after each intervention, knowledge gains attributable to these interventions were distinguished from practice effects. Unexpected increases in acquittals following deliberation underscored the importance of adding adequate control groups and of testing deliberation effects in jury simulation studies. Benefits of this research paradigm to assist courts, legal counsel and policy makers in devising effective methods to enhance jury decisions in complex criminal cases are discussed. Cuando los miembros del jurado popular no están familiarizados con los temas probatorios clave, las pruebas periciales, las instrucciones judiciales y la deliberación de grupo pueden mejorar su comprensión de las evidencias. Se ofrecen pasos sistemáticos para evaluar la relación entre sesgos del jurado en casos de abusos a menores como un ejemplo para ilustrar un enfoque de investigación programática. Se probó y comparó la efectividad de tres garantías procesales jurídicas tradicionales para reducir los malentendidos comunes de los jurados en el contexto de juicios simulados, usando patrones de investigación pre y post análisis. Al medir el conocimiento de jurados en juicios simulados antes y después de cada intervención, se distinguían los conocimientos adquiridos atribuibles a estas intervenciones. Un aumento inesperado de absoluciones después de la deliberación pon

  15. Juri Lotmani raamatu tõlge kandideerib USAs auhinnale

    Index Scriptorium Estoniae

    2014-01-01

    Juri Lotmani monograafia "Непредсказуемые механизмы культуры" tõlge inglise keelde "The Unpredictable Workings of Culture" nomineeriti Ameerika Slaavi ja Ida-Euroopa Keelte Õpetajate Ühingu 2013. aasta parima tõlkeraamatu auhinnale. Tõlke autor on Kenti Ülikooli slavistika professor Brian Baer ning raamat on ilmunud Tallinna Ülikooli Kirjastuse väljaandena

  16. Is 'good' communication achievable in jury instructions? Applying communication theory to instances of instructions in jury trials.

    Directory of Open Access Journals (Sweden)

    Patrizia Anesa

    2012-08-01

    Full Text Available Stating that 'good' communication plays a crucial role in everybody's personal and professional life would be to state the obvious. However, this well-established concept constantly seems to call for a reflection upon basic questions, such as: how can we define 'good' communication? What are the criteria that can be applied  in order to identify it and to discern it, if possible, from 'bad' communication? Is it possible to achieve it? How? Between whom? In which circumstances? What are its consequences?

  17. Hotel guest's $14.5 million jury verdict set aside on appeal.

    Science.gov (United States)

    1999-08-20

    A Missouri Court of Appeals judge reversed a $14.5 million judgement against [name removed] Inc., which had been held liable for the beating and sexual assault of a guest in its hotel. The guest, identified as [name removed], had requested an upgrade to a concierge room, to increase her safety, but the hotel did not fill her request. When [name removed] opened her hotel room door the next morning, an assailant attacked, beat and raped her. The assailant escaped hotel security, but was later apprehended. The initial case against [name removed] and the assailant resulted in a $22.5 million judgement for [name removed] Both parties appealed. [Name removed] prevailed in its argument that the initial trial judge misinstructed the jury, and that [name removed] was unable to show clear and convincing evidence that the hotel's willful or conscious disregard for guest safety caused the situation. However, the court ruled against [name removed] on the basis of [name removed]'s fear-of-AIDS claim, because of her exposure to the virus.

  18. Novas estratégias em educação: avaliação da técnica Tribunal do Júri na capacitação de conselheiros na área de saúde da mulher em Santa Catarina, Brasil New educational strategies: evaluation of the Jury Trial technique for training council members in women's health in Santa Catarina, Brazil

    Directory of Open Access Journals (Sweden)

    Eleonor Minho Conill

    2003-04-01

    Full Text Available Descreve-se e avalia-se a técnica Tribunal do Júri, instrumento educativo inovador utilizado em uma oficina piloto sobre Controle Social e Gênero para conselheiros de saúde da Grande Florianópolis, Santa Catarina, Brasil. Estudaram-se sua confiabilidade e validade utilizando a opinião dos participantes complementado com observação qualitativa dos trabalhos. Houve unanimidade na aceitação da técnica por parte dos conselheiros pela "aquisição de conhecimentos" e "por ser participativa, democrática e dinâmica". A avaliação positiva coincide com trabalho anterior feito com secretários municipais, notando-se menor preferência por atividades cognitivas formais que também compunham a oficina. Conclui-se reforçando a importância do uso dessa inovação em capacitações, por ser aceita por públicos distintos, permitir o mapeamento de conteúdo programático e ser útil face a temáticas novas e polêmicas ao favorecer vivências práticas e reflexivas.This article describes and evaluates the Jury Trial technique, an innovative educational instrument used in a pilot workshop on Social Control and Gender by health council members in Greater Metropolitan Florianópolis, Santa Catarina, Brazil. The reliability and validity were studied based on the participants' opinions, complemented by qualitative observation of the work. There was consensus in acceptance of the technique based on "acquisition of knowledge" and the fact that it was participatory, democratic, and dynamic. The positive evaluation agrees with a previous study that interviewed municipal health secretaries, with a smaller preference of formal cognitive activities that were also part of the workshop. The article concludes by emphasizing the importance of this innovative technique in training programs, since it is accepted by different target publics, allows for designing the program contents, and is useful in relation to new and controversial issues since it favors

  19. Argumentation in Science Teacher Education: The simulated jury as a resource for teaching and learning

    Science.gov (United States)

    Drumond Vieira, Rodrigo; da Rocha Bernardo, José Roberto; Evagorou, Maria; Florentino de Melo, Viviane

    2015-05-01

    In this article, we focus on the contributions that a simulated jury-based activity might have for pre-service teachers, especially for their active participation and learning in teacher education. We observed a teacher educator using a series of simulated juries as teaching resources to help pre-service teachers develop their pedagogical knowledge and their argumentation abilities in a physics teacher methods course. For the purposes of this article, we have selected one simulated jury-based activity, comprising two opposed groups of pre-service teachers that presented aspects that hinder the teachers' development of professional knowledge (against group) and aspects that allow this development (favor group). After the groups' presentations, a group of judges was formed to evaluate the discussion. We applied a multi-level method for discourse analysis and the results showed that (1) the simulated jury afforded the pre-service teachers to position themselves as active knowledge producers; (2) the teacher acted as 'animator' of the pre-service teachers' actions, showing responsiveness to the emergence of circumstantial teaching and learning opportunities and (3) the simulated jury culminated in the judges' identification of the pattern 'concrete/obstacles-ideological/possibilities' in the groups' responses, which was elaborated by the teacher for the whole class. Implications from this study include using simulated juries for teaching and learning and for the development of the pre-service teachers' argumentative abilities. The potential of simulated juries to improve teaching and learning needs to be further explored in order to inform the uses and reflections of this resource in science education.

  20. Social Justice and Environmental Awareness Developed through a Citizens' Jury

    Science.gov (United States)

    Knight, J.

    2014-12-01

    A Citizens' Jury (CJ) is a discussion forum in which managers, policymakers or politicians are able to present their case to the general public ('citizens') to whom they are accountable, and for these citizens to critically ask questions of the managers/policymakers/politicians in order to better understand issues surrounding local development, planning and policy, impacts and adaptive measures, and to highlight their concerns. A CJ can be useful with respect to developing social justice and environmental awareness issues because it can empower community action and present different viewpoints. A practical CJ exercise is used in a second-year undergraduate course entitled Climate Change and Society, at University of the Witwatersrand, Johannesburg, South Africa. The CJ is used to consider some of the impacts of management policies used for climate change and sustainable development adaption, based on a hypothetical scenario. This scenario is that a major energy company wants to build a dam with hydroelectric power station in a developing country. This will provide low-carbon renewable energy to the country, investment in electricity infrastructure, and the company is committed to help economic development in the country, including in jobs and education. However, building and flooding of the dam will involve displacing 10,000 people from rural communities, flooding agricultural areas and areas of high biodiversity, and archaeological sites. The exercise is based on students, in groups, assuming different 'identities' which may include a local business person, resident, politician, member of an NGO, tourist, engineer, farmer etc, from which viewpoint they must argue for/against the proposal and to question other peoples' viewpoints. This exercise is useful because it allows students to develop understandings of different viewpoints, evaluate risk and impacts on different communities, and highlights the complexity of real-world decision-making.

  1. Application of uti possidetis juris principle in the process of determination of international borders

    Directory of Open Access Journals (Sweden)

    Tubić Bojan

    2011-01-01

    Full Text Available Uti possidetis juris principle was basic rule in determining international borders in the period of decolonization. It was applied in Latin America and Africa, but also at the end of 20th century in the processes of dissolution of USSR, SFRY and Czechoslovakia. Uti possidetis juris principle is based on the presumption that former colonial administrative borders kept stability and territorial integrity. It was undoubtedly connected with the right of self-determination. It keeps the existing borders by preventing secession, but in that way it does not solve the problem of badly determined and disputed borders. The unclear foundations on which the borders were determined can be a source of chaos and indisputes, which was shown n some cases before the International Court of Justice. The dominant theory is that uti possidetis juris principle should be applied with certain limitations, in the period after decolonization as a basis for preserving the territorial integrity of postcolonial states.

  2. "Ja rabotaju na zhenshtshin", govorit znamenitõi rezhissjor Juri Jerjomin / Polina Nilina

    Index Scriptorium Estoniae

    Nilina, Polina

    2006-01-01

    5.-7. juulini toimuvad Estonia teatris Moskva Mossoveti-nim. Teatri külalisetendused. Juri Jerjomini lavastus "Mees, naine ja armuke" F. Dostojevski ja I. Turgenevi teoste põhjal, peaosas Valentin Gaft ning lavastus Tennessee Williamsi järgi "Tramm nimega Iha". Teatrist, näitlejatest, lavastustest

  3. The problem of the autocatalytic origin of culture in Juri Lotman's cultural philosophy / Linnar Priimägi

    Index Scriptorium Estoniae

    Priimägi, Linnar, 1954-

    2005-01-01

    Kultuuri ülesehitusest ja funktsioonidest Juri Lotmani kultuurifilosofias. Kultuuri autokatalüütilisuses on paradoks, mille kohaselt kultuur ei saa tekkida millegi muu kui kultuuri olemasolu eeldusel

  4. An optimized outlier detection algorithm for jury-based grading of engineering design projects

    DEFF Research Database (Denmark)

    Thompson, Mary Kathryn; Espensen, Christina; Clemmensen, Line Katrine Harder

    2016-01-01

    This work characterizes and optimizes an outlier detection algorithm to identify potentially invalid scores produced by jury members while grading engineering design projects. The paper describes the original algorithm and the associated adjudication process in detail. The impact of the various...... (the base rule and the three additional conditions) play a role in the algorithm's performance and should be included in the algorithm. Because there is significant interaction between the base rule and the additional conditions, many acceptable combinations that balance the FPR and FNR can be found......, but no true optimum seems to exist. The performance of the best optimizations and the original algorithm are similar. Therefore, it should be possible to choose new coefficient values for jury populations in other cultures and contexts logically and empirically without a full optimization as long...

  5. Yes, the government should tax soft drinks: findings from a citizens' jury in Australia.

    Science.gov (United States)

    Moretto, Nicole; Kendall, Elizabeth; Whitty, Jennifer; Byrnes, Joshua; Hills, Andrew P; Gordon, Louisa; Turkstra, Erika; Scuffham, Paul; Comans, Tracy

    2014-02-27

    Taxation has been suggested as a possible preventive strategy to address the serious public health concern of childhood obesity. Understanding the public's viewpoint on the potential role of taxation is vital to inform policy decisions if they are to be acceptable to the wider community. A Citizens' Jury is a deliberative method for engaging the public in decision making and can assist in setting policy agendas. A Citizens' Jury was conducted in Brisbane, Australia in May 2013 to answer the question: Is taxation on food and drinks an acceptable strategy to the public in order to reduce rates of childhood obesity? Citizens were randomly selected from the electoral roll and invited to participate. Thirteen members were purposively sampled from those expressing interest to broadly reflect the diversity of the Australian public. Over two days, participants were presented with evidence on the topic by experts, were able to question witnesses and deliberate on the evidence. The jurors unanimously supported taxation on sugar-sweetened drinks but generally did not support taxation on processed meats, snack foods and foods eaten/ purchased outside the home. They also supported taxation on snack foods on the condition that traffic light labelling was also introduced. Though they were not specifically asked to deliberate strategies outside of taxation, the jurors strongly recommended more nutritional information on all food packaging using the traffic light and teaspoon labelling systems for sugar, salt and fat content. The Citizens' Jury suggests that the general public may support taxation on sugar-sweetened drinks to reduce rates of obesity in children. Regulatory reforms of taxation on sugar-sweetened drinks and improved labelling of nutritional information on product packaging were strongly supported by all members of the jury. These reforms should be considered by governments to prevent childhood obesity and the future burden on society from the consequences of obesity.

  6. Excusable neglect in malpractice suits against radiologists: a proposed jury instruction to recognize the human condition.

    Science.gov (United States)

    Caldwell, Charles; Seamone, Evan R

    2007-01-01

    This article unwraps the nature and source of human errors involved in Radiology, revealing unique elements of the specialty that warrant special consideration in medical malpractice cases. The authors compare these errors to negligent practices in other professions and conclude that a general concept of negligence cannot adequately address the complexities of decision-making in Radiology. After analyzing legal precedent, they develop an innovative jury instruction that recognizes particular situations of error in Radiology that occur in the absence of negligence.

  7. Yes, The Government Should Tax Soft Drinks: Findings from a Citizens’ Jury in Australia

    Science.gov (United States)

    Moretto, Nicole; Kendall, Elizabeth; Whitty, Jennifer; Byrnes, Joshua; Hills, Andrew P.; Gordon, Louisa; Turkstra, Erika; Scuffham, Paul; Comans, Tracy

    2014-01-01

    Taxation has been suggested as a possible preventive strategy to address the serious public health concern of childhood obesity. Understanding the public’s viewpoint on the potential role of taxation is vital to inform policy decisions if they are to be acceptable to the wider community. A Citizens’ Jury is a deliberative method for engaging the public in decision making and can assist in setting policy agendas. A Citizens’ Jury was conducted in Brisbane, Australia in May 2013 to answer the question: Is taxation on food and drinks an acceptable strategy to the public in order to reduce rates of childhood obesity? Citizens were randomly selected from the electoral roll and invited to participate. Thirteen members were purposively sampled from those expressing interest to broadly reflect the diversity of the Australian public. Over two days, participants were presented with evidence on the topic by experts, were able to question witnesses and deliberate on the evidence. The jurors unanimously supported taxation on sugar-sweetened drinks but generally did not support taxation on processed meats, snack foods and foods eaten/ purchased outside the home. They also supported taxation on snack foods on the condition that traffic light labelling was also introduced. Though they were not specifically asked to deliberate strategies outside of taxation, the jurors strongly recommended more nutritional information on all food packaging using the traffic light and teaspoon labelling systems for sugar, salt and fat content. The Citizens’ Jury suggests that the general public may support taxation on sugar-sweetened drinks to reduce rates of obesity in children. Regulatory reforms of taxation on sugar-sweetened drinks and improved labelling of nutritional information on product packaging were strongly supported by all members of the jury. These reforms should be considered by governments to prevent childhood obesity and the future burden on society from the consequences of

  8. Yes, The Government Should Tax Soft Drinks: Findings from a Citizens’ Jury in Australia

    Directory of Open Access Journals (Sweden)

    Nicole Moretto

    2014-02-01

    Full Text Available Taxation has been suggested as a possible preventive strategy to address the serious public health concern of childhood obesity. Understanding the public’s viewpoint on the potential role of taxation is vital to inform policy decisions if they are to be acceptable to the wider community. A Citizens’ Jury is a deliberative method for engaging the public in decision making and can assist in setting policy agendas. A Citizens’ Jury was conducted in Brisbane, Australia in May 2013 to answer the question: Is taxation on food and drinks an acceptable strategy to the public in order to reduce rates of childhood obesity? Citizens were randomly selected from the electoral roll and invited to participate. Thirteen members were purposively sampled from those expressing interest to broadly reflect the diversity of the Australian public. Over two days, participants were presented with evidence on the topic by experts, were able to question witnesses and deliberate on the evidence. The jurors unanimously supported taxation on sugar-sweetened drinks but generally did not support taxation on processed meats, snack foods and foods eaten/ purchased outside the home. They also supported taxation on snack foods on the condition that traffic light labelling was also introduced. Though they were not specifically asked to deliberate strategies outside of taxation, the jurors strongly recommended more nutritional information on all food packaging using the traffic light and teaspoon labelling systems for sugar, salt and fat content. The Citizens’ Jury suggests that the general public may support taxation on sugar-sweetened drinks to reduce rates of obesity in children. Regulatory reforms of taxation on sugar-sweetened drinks and improved labelling of nutritional information on product packaging were strongly supported by all members of the jury. These reforms should be considered by governments to prevent childhood obesity and the future burden on society from

  9. Investigating the Extent to Which Patients Should Control Access to Patient Records for Research: A Deliberative Process Using Citizens’ Juries

    Science.gov (United States)

    Bozentko, Kyle; Clement, Sarah; Hunn, Amanda; Hassan, Lamiece; Norris, Ruth; Oswald, Malcolm; Peek, Niels

    2018-01-01

    Background The secondary use of health data for research raises complex questions of privacy and governance. Such questions are ill-suited to opinion polling where citizens must choose quickly between multiple-choice answers based on little information. Objective The aim of this project was to extend knowledge about what control informed citizens would seek over the use of health records for research after participating in a deliberative process using citizens’ juries. Methods Two 3-day citizens’ juries, of 17 citizens each, were convened to reflect UK national demographics from 355 eligible applicants. Each jury addressed the mission “To what extent should patients control access to patient records for secondary use?” Jurors heard from and questioned 5 expert witnesses (chosen either to inform the jury, or to argue for and against the secondary use of data), interspersed with structured opportunities to deliberate among themselves, including discussion and role-play. Jurors voted on a series of questions associated with the jury mission, giving their rationale. Individual views were polled using questionnaires at the beginning and at end of the process. Results At the end of the process, 33 out of 34 jurors voted in support of the secondary use of data for research, with 24 wanting individuals to be able to opt out, 6 favoring opt in, and 3 voting that all records should be available without any consent process. When considering who should get access to data, both juries had very similar rationales. Both thought that public benefit was a key justification for access. Jury 1 was more strongly supportive of sharing patient records for public benefit, whereas jury 2 was more cautious and sought to give patients more control. Many jurors changed their opinion about who should get access to health records: 17 people became more willing to support wider information sharing of health data for public benefit, whereas 2 moved toward more patient control over

  10. (REThinking the Legal Education Through the Storytelling Practices: The Example of the Jury

    Directory of Open Access Journals (Sweden)

    Tamer Fakhoury Filho

    2016-10-01

    Full Text Available It is necessary to (rethink legal education using new methodologies. This requires changing the dominant mindset in teaching and practice of law (still essentially based on conflict and judicial proceedings. A new model can be implemented with the strategic analysis of the law and the storytelling. The storytelling in the classroom and in professional practice, is one of the viable ways to implement these changes. As the storytelling is already used in the jury, it can also be used in other professional fields and enhanced as a tool teaching of law, regardless of discipline.

  11. Beyond the 2008 Justice Reforms: Establishing a Legitimate Rule of Law in Mexico with Jury Trials

    Science.gov (United States)

    2011-10-28

    States with separation of powers , including executive, legislative, and judicial branches, granted by the 1917 Constitution. The executive branch role...law system prevents an overreaching judicial branch from legislating new laws. This provides a strong separation of powers . However, when coupled

  12. Engaging the public in healthcare decision-making: results from a Citizens' Jury on emergency care services.

    Science.gov (United States)

    Scuffham, P A; Moretto, N; Krinks, R; Burton, P; Whitty, J A; Wilson, A; Fitzgerald, G; Littlejohns, P; Kendall, E

    2016-11-01

    Policies addressing ED crowding have failed to incorporate the public's perspectives; engaging the public in such policies is needed. This study aimed at determining the public's recommendations related to alternative models of care intended to reduce crowding, optimising access to and provision of emergency care. A Citizens' Jury was convened in Queensland, Australia, to consider priority setting and resource allocation to address ED crowding. Twenty-two jurors were recruited from the electoral roll, who were interested and available to attend the jury from 15 to 17 June 2012. Juror feedback was collected via a survey immediately following the end of the jury. The jury considered that all patients attending the ED should be assessed with a minority of cases diverted for assistance elsewhere. Jurors strongly supported enabling ambulance staff to treat patients in their homes without transporting them to the ED, and allowing non-medical staff to treat some patients without seeing a doctor. Jurors supported (in principle) patient choice over aspects of their treatment (when, where and type of health professional) with some support for patients paying towards treatment but unanimous opposition for patients paying to be prioritised. Most of the jurors were satisfied with their experience of the Citizens' Jury process, but some jurors perceived the time allocated for deliberations as insufficient. These findings suggest that the general public may be open to flexible models of emergency care. The jury provided clear recommendations for direct public input to guide health policy to tackle ED crowding. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

  13. How a deliberative approach includes women in the decisions of screening mammography: a citizens' jury feasibility study in Andalusia, Spain

    Science.gov (United States)

    Baena-Cañada, José M; Luque-Ribelles, Violeta; Quílez-Cutillas, Alicia; Rosado-Varela, Petra; Benítez-Rodríguez, Encarnación; Márquez-Calderón, Soledad; Rivera-Bautista, Juan Manuel

    2018-01-01

    Objectives To verify whether a citizens' jury study is feasible to the Andalusian population and to know if women, when better informed, are able to answer the research question of whether the Andalusian Public Health System must continue offering screening mammography to women aged 50–69. The reasons for the pertinent decision and recommendations to the political authorities will be stated. Design Qualitative research study with the methodology of citizens' jury. Setting Breast cancer screening programme in Andalusia (Spain). Participants Thirteen women aged 50–69 with secondary school or higher education accepted to participate as a jury. Two epidemiologists were the expert witnesses. The main researcher was the neutral moderator. Interventions Jury met on Monday, 15 February 2016. The moderator indicated to the jury that it had to assess the screening programme’s key benefits and main harm. On Tuesday, 16 February, the expert witnesses positioned for and against the programme. On Thursday, 18 February, the jury deliberated, reached final conclusions, submitted its vote and stated its recommendations to politicians. The deliberation session was transcribed and analysed with the support of ATLAS.ti.5.2 software. Primary and secondary outcome measures Feasibility in the Andalusian population, women’s vote and opinion, reasons for votes and recommendations to political authorities. Results Eleven participants voted yes and two voted no. There are three reasons to vote ‘yes’: health, the test nature, and individual freedom. Some women invoke the lack of efficacy and the cost to justify their negative vote, at least in universal terms. On completion, they made suggestions to be submitted to the pertinent authorities for the improvement of information, psychology services and research. Conclusions The deliberative strategy is feasible and causes a favourable positioning regarding screening mammography, although information changes the opinion of some women

  14. Simulated jury and brain storm: Understanding the implementation of Belo Monte Hydroelectric dam

    Directory of Open Access Journals (Sweden)

    Marcos Marques Formigosa

    2017-12-01

    Full Text Available The physics teaching still finds many obstacles in basic education, mainly because of the strong resistance that we find within its methodologies, still centered in the didactic book and the memorization of formulas and laws. This manuscript aims to present the results of the strategies of Simulated Jury and Brain Storm developed in a Countryside Education Degree (emphasis in Natural Sciences, specifically at Fundamentals of Physics III in two classes of the 4th Period, in the countryside Of Paraense Amazon. In one class we used the strategy Cerebral Storm and another strategy was the Simulated Jury, the Electricity content. The analyzes were made based on the reports of the students in the class and notes made by the teacher/researcher. These developed strategies allowed the rupture of the stereotypes presented among the students about the methodologies used by their teachers in teaching Physics contents, which was based on traditional expository classes, and with the strategies used they realized that they can approach the contents of and, above all, led them to a critical reality understanding in which they are inserted.

  15. Introducing consumer directed care in residential care settings for older people in Australia: views of a citizens' jury.

    Science.gov (United States)

    Laver, Kate; Gnanamanickam, Emmanuel; Whitehead, Craig; Kurrle, Susan; Corlis, Megan; Ratcliffe, Julie; Shulver, Wendy; Crotty, Maria

    2018-01-01

    Objectives Health services worldwide are increasingly adopting consumer directed care approaches. Traditionally, consumer directed care models have been implemented in home care services and there is little guidance as to how to implement them in residential care. This study used a citizens' jury to elicit views of members of the public regarding consumer directed care in residential care. Methods A citizens' jury involving 12 members of the public was held over two days in July 2016, exploring the question: For people with dementia living in residential care facilities, how do we enable increased personal decision making to ensure that care is based on their needs and preferences? Jury members were recruited through a market research company and selected to be broadly representative of the general public. Results The jury believed that person-centred care should be the foundation of care for all older people. They recommended that each person's funding be split between core services (to ensure basic health, nutrition and hygiene needs are met) and discretionary services. Systems needed to be put into place to enable the transition to consumer directed care including care coordinators to assist in eliciting resident preferences, supports for proxy decision makers, and accreditation processes and risk management strategies to ensure that residents with significant cognitive impairment are not taken advantage of by goods and service providers. Transparency should be increased (perhaps using technologies) so that both the resident and nominated family members can be sure that the person is receiving what they have paid for. Conclusions The views of the jury (as representatives of the public) were that people in residential care should have more say regarding the way in which their care is provided and that a model of consumer directed care should be introduced. Policy makers should consider implementation of consumer directed care models that are economically viable

  16. A "nudge" at all? The jury is still out on financial health incentives.

    Science.gov (United States)

    Mitchell, Marc; Faulkner, Guy

    2012-01-01

    A comprehensive, multi-level approach to curb chronic disease-related costs in Canada is needed. One target for intervention is the economic domain. The emergence of user financial incentives (UFI) in public health policy as well as their broad implementation in corporate settings has stimulated a growing but limited body of research in this area. The authors'position is that the jury is still out on the question of their effectiveness in sustaining long-term health behaviour change, given the nature of the UFI that have been designed and delivered to date--that is, UFI with limited theoretical and contextual consideration. It is their contention that manipulating UFI design features (there are seven core features with a range of attributes) to exploit contextual (e.g., personal income) and theoretical (e.g., self-efficacy) factors may optimize UFI effectiveness over the long term. Although UFI are not the solution, they might very well be apart.

  17. Harnessing the Potential to Quantify Public Preferences for Healthcare Priorities through Citizens’ Juries

    Directory of Open Access Journals (Sweden)

    Jennifer A. Whitty

    2014-07-01

    Full Text Available Despite progress towards greater public engagement, questions about the optimal approach to access public preferences remain unanswered. We review two increasingly popular methods for engaging the public in healthcare priority-setting and determining their preferences; the Citizens’ Jury (CJ and Discrete Choice Experiment (DCE. We discuss the theoretical framework from which each method is derived, its application in healthcare, and critique the information it can provide for decision-makers. We conclude that combining deliberation of an informed public via CJs and quantification of preferences using DCE methods, whilst it remains to be tested as an approach to engaging the public in priority-setting, could potentially achieve much richer information than the application of either method in isolation.

  18. Reflections from the Jury Box: Improving Evidence Based Practice through a Comparison with Our Legal System

    Directory of Open Access Journals (Sweden)

    Valerie Coppenrath

    2017-08-01

    Full Text Available Background: An experience serving jury duty prompted reflection on the parallels between evidenced based medicine and our legal system. Findings: The steps of the legal system can be tied to each step of the practice of evidenced based medicine. Implications: Patients should be included in evidence based decisions. Pharmacists can act as resources for other providers practicing evidenced based medicine. Educators can use this analogy to teach evidence based medicine. Conflict of Interest We declare no conflicts of interest or financial interests that the authors or members of their immediate families have in any product or service discussed in the manuscript, including grants (pending or received, employment, gifts, stock holdings or options, honoraria, consultancies, expert testimony, patents and royalties.   Type: Commentary

  19. Involving a Citizens' Jury in Decisions on Individual Screening for Prostate Cancer.

    Directory of Open Access Journals (Sweden)

    Paola Mosconi

    Full Text Available Most public health agencies and learned societies agree that the prostate-specific antigen (PSA test in asymptomatic men should not be recommended, on account of its potential for harm. Yet PSA is still widely used as a screening test and is not being abandoned. This remains a significant public health issue, and citizens' engagement is needed. This study was designed to produce a deliberation on the PSA screening test by a citizens' jury.Fifteen citizens were selected and balanced for sex, age, and education. They received an information booklet and participated in a two-day meeting with experts to reach a deliberation on the question "Should the National Health Service discourage or recommend PSA as an individual screening test for prostate cancer in men 55-69 years old?". A facilitator ran the jurors' discussion.All except three of the jurors decided that the National Health Service should discourage the use of PSA as an individual screening test for prostate cancer in 55-69 year-old men. The jury was particularly convinced by the uncertainty of the test outcomes, the utility of the test, and its cost/benefit ratio. Before the meeting 60% of jurors would have recommended the test to a relative, and all the male jurors would have done so. After the meeting these percentages fell to 15% and 12%.This experience confirms the feasibility and effectiveness of delegating to a group of citizens the responsibility to decide on public health issues on behalf of the community. Public health authorities should invest in information campaigns aimed at the public and in educational initiatives for physicians. This also provided an opportunity to disseminate information on screening, over-diagnosis, and over-treatment.

  20. Introduction to Juries and Mixed Tribunals across the Globe: New Developments, Common Challenges and Future Directions

    Directory of Open Access Journals (Sweden)

    Nancy S. Marder

    2016-06-01

    Full Text Available The introduction to the special issue describes the goals of the conference on Juries and Mixed Tribunals across the Globe, and identifies themes that emerged as jury scholars from all over the world examined different forms of lay participation in legal decision-making. The introduction focuses on common challenges that different systems of lay participation face, including the selection of impartial fact finders and the presentation of complex cases to lay citizens. The introduction and special issue articles also highlight new developments and innovative practices to address these challenges, including some tools, like decision trees, that remain highly controversial. The introduction closes by emphasizing the enduring political importance of citizen participation in law. La introducción a este número especial describe los objetivos de la conferencia sobre jurados y tribunales mixtos en el mundo, e identifica los temas que surgieron cuando académicos de todo el mundo especializados en jurados analizaron diferentes formas de participación de legos en la toma de decisiones jurídicas. La introducción se centra en los desafíos comunes a los que se enfrentan los diferentes sistemas de participación de legos, incluyendo la selección de jurados imparciales y la presentación de casos complejos a ciudadanos profanos en la materia. La introducción y el número especial también destacan nuevos desarrollos y prácticas innovadoras para afrontar estos retos, incluyendo algunas herramientas, como los árboles de decisiones, que todavía son muy controvertidas. La introducción finaliza, haciendo hincapié en la importancia política duradera de la participación ciudadana en el derecho. DOWNLOAD THIS PAPER FROM: http://ssrn.com/abstract=2785708

  1. Expert Testimony, "Regular People," and Public Values: Arguing Common Sense at a Death Penalty Trial.

    Science.gov (United States)

    Chappell, Virginia A.

    1995-01-01

    Presents a case study of a particular courtroom case dealing with the death penalty. Analyzes the processes and communications of the trial jury. Discusses the interplay of common-sense and expert claims at three crucial stages of the trial. (HB)

  2. Effects of trial complexity on decision making.

    Science.gov (United States)

    Horowitz, I A; ForsterLee, L; Brolly, I

    1996-12-01

    The ability of a civil jury to render fair and rational decisions in complex trials has been questioned. However, the nature, dimensions, and effects of trial complexity on decision making have rarely been addressed. In this research, jury-eligible adults saw a videotape of a complex civil trial that varied in information load and complexity of the language of the witnesses. Information load and complexity differentially affected liability and compensatory decisions. An increase in the number of plaintiffs decreased blameworthiness assigned to the defendant despite contrary evidence and amount of probative evidence processed. Complex language did not affect memory but did affect jurors' ability to appropriately compensate differentially worthy plaintiffs. Jurors assigned compensatory awards commensurate with the plaintiffs' injuries only under low-load and less complex language conditions.

  3. Community perspectives on the use of regulation and law for obesity prevention in children: A citizens' jury.

    Science.gov (United States)

    Street, Jackie M; Sisnowski, Jana; Tooher, Rebecca; Farrell, Lucy C; Braunack-Mayer, Annette J

    2017-05-01

    Childhood obesity is a significant challenge for public health internationally. Regulatory and fiscal measures propagated by governments offer a potentially effective response to this issue. Fearing public criticism, governments are often reluctant to use such measures. In this study we asked a descriptively representative and informed group of Australians their views on the use of legislation and fiscal measures by governments to address childhood obesity. A citizens' jury, held in South Australia in April 2015, was asked to consider the question: What laws, if any, should we have in Australia to address childhood obesity? The jury agreed that prevention of obesity was complex requiring multifaceted government intervention. Recommendations fell into the areas of health promotion and education (n=4), regulation of food marketing (n=3), taxation/subsidies (n=2) and a parliamentary enquiry. School-based nutrition education and health promotion and mandatory front-of-pack interpretive labelling of food and drink were ranked 1 and 2 with taxation of high fat, high sugar food and drink third. The recommendations were similar to findings from other citizens' juries held in Australia suggesting that the reticence of decision makers in Australia, and potentially elsewhere, to use legislative and fiscal measures to address childhood obesity is misguided. Supporting relevant informed public discussion could facilitate a politically acceptable legislative approach. Copyright © 2017 Elsevier B.V. All rights reserved.

  4. A citizens' jury on regulation of McDonald's products and operations in Australia in response to a corporate health impact assessment.

    Science.gov (United States)

    Anaf, Julia; Baum, Fran; Fisher, Matthew

    2018-04-01

    1) To report outcomes from a citizens' jury examining regulatory responses to the health impacts of McDonald's Australia; 2) To determine the value of using citizens' juries to develop policy recommendations based on the findings of health impact assessment of transnational corporations (TNCs). A citizens' jury engaged 15 randomly selected and demographically representative jurors from metropolitan Adelaide to deliberate on the findings of a Corporate Health Impact Assessment, and to decide on appropriate policy actions. Jurors unanimously called for government regulation to ensure that transnational fast food corporations pay taxes on profits in the country of income. A majority (two-thirds) also recommended government regulation to reduce fast food advertising, and improve standards of consumer information including a star-ratings system. A minority held the view that no further regulation is required of the corporate fast food industry in Australia. The jury's recommendations can help inform policy makers about the importance of ending the legal profit-shifting strategies by TNCs that affect taxation revenue. They also endorse regulating the fast food industry to provide healthier food, and employing forms of community education and awareness-raising. Implications for public health: Citizens' juries can play an important role in providing feedback and policy recommendations in response to the findings of a health impact assessment of transnational corporations. © 2018 The Authors.

  5. When domestic goes capital: Juror decision making in capital murder trials involving domestic homicide.

    Science.gov (United States)

    Richards, Tara N; Smith, M Dwayne; Fogel, Sondra J; Bjerregaard, Beth

    2015-08-01

    Prior research suggests that homicide cases involving familial offenders and victims are subject to a "domestic discount" that reduces sentencing severity. However, the operation of a domestic discount in regard to death penalty sentencing has been rarely examined. The current research uses a near-population of jury decisions in capital murder trials conducted in North Carolina from 1991 to 2009 (n = 800), and a series of logistic regression analyses to determine whether there is (a) a direct effect between offender-victim relationship (e.g., domestic, friend/acquaintance, and stranger) and jury decision making, and/or (b) whether domestic offender-victim relationship (as well as other offender-victim relationships) moderates the effect of legal and extralegal case characteristics on jury assessment of the death penalty. Our findings revealed no empirical support for a "domestic discount" whereby juries are less likely to impose death sentences in cases involving domestic homicides. However, substantial differences in predictors of death sentencing were found across offender-victim dyads; most notably, domestic homicide cases demonstrated the most legalistic model of jury decisions to impose death sentences. (c) 2015 APA, all rights reserved).

  6. La teoría de los diferenciales de Salomon Maimon, la pregunta quid juris y la posibilidad de la metafísica como ciencia

    Directory of Open Access Journals (Sweden)

    Hernán Pringe

    2016-06-01

    Full Text Available Este trabajo estudia la teoría de los diferenciales de Salomon Maimon como respuesta a la cuestión quid juris y a la vez como clave para la fundamentación de la posibilidad de la metafísica como ciencia. Se reconstruye primero la crítica de Maimon al tratamiento kantiano de la pregunta quid juris. Luego, se analiza la respuesta del propio Maimon a esa pregunta, para establecer finalmente cómo tal respuesta abre el camino para la explicación de la posibilidad de la metafísica como ciencia.

  7. What choices should we be able to make about designer babies? A Citizens' Jury of young people in South Wales.

    Science.gov (United States)

    Iredale, Rachel; Longley, Marcus; Thomas, Christian; Shaw, Anita

    2006-09-01

    Young people will increasingly have the option of using new technologies for reproductive decision making but their voices are rarely heard in debates about acceptable public policy in this area. Capturing the views of young people about potentially esoteric topics, such as genetics, is difficult and methodologically challenging. A Citizens' Jury is a deliberative process that presents a question to a group of ordinary people, allows them to examine evidence given by expert witnesses and personal testimonies and arrive at a verdict. This Citizens' Jury explored designer babies in relation to inherited conditions, saviour siblings and sex selection with young people. Fourteen young people aged 16-19 in Wales. Acceptance of designer baby technology was purpose-specific; it was perceived by participants to be acceptable for preventing inherited conditions and to create a child to save a sibling, but was not recommended for sex selection. Jurors stated that permission should not depend on parents' age, although some measure of suitability should be assessed. Preventing potential parents from going abroad was considered impractical. These young people felt the Human Fertilisation and Embryology Authority should have members under 20 and that the term 'designer baby' was not useful. Perspectives on the acceptability of this technology were nuanced, and based on implicit value judgements about the extent of individual benefit derived. Young people have valuable and interesting contributions to make to the debate about genetics and reproductive decision making and a variety of innovative methods must be used to secure their involvement in decision-making processes.

  8. What choices should we be able to make about designer babies? A Citizens’ Jury of young people in South Wales

    Science.gov (United States)

    Iredale, Rachel; Longley, Marcus; Thomas, Christian; Shaw, Anita

    2006-01-01

    Abstract Background  Young people will increasingly have the option of using new technologies for reproductive decision making but their voices are rarely heard in debates about acceptable public policy in this area. Capturing the views of young people about potentially esoteric topics, such as genetics, is difficult and methodologically challenging. Design  A Citizens’ Jury is a deliberative process that presents a question to a group of ordinary people, allows them to examine evidence given by expert witnesses and personal testimonies and arrive at a verdict. This Citizens’ Jury explored designer babies in relation to inherited conditions, saviour siblings and sex selection with young people. Participants  Fourteen young people aged 16–19 in Wales. Results  Acceptance of designer baby technology was purpose‐specific; it was perceived by participants to be acceptable for preventing inherited conditions and to create a child to save a sibling, but was not recommended for sex selection. Jurors stated that permission should not depend on parents’ age, although some measure of suitability should be assessed. Preventing potential parents from going abroad was considered impractical. These young people felt the Human Fertilisation and Embryology Authority should have members under 20 and that the term ‘designer baby’ was not useful. Conclusions  Perspectives on the acceptability of this technology were nuanced, and based on implicit value judgements about the extent of individual benefit derived. Young people have valuable and interesting contributions to make to the debate about genetics and reproductive decision making and a variety of innovative methods must be used to secure their involvement in decision‐making processes. PMID:16911135

  9. Trials

    Directory of Open Access Journals (Sweden)

    Michele Fornaro

    2010-01-01

    Full Text Available Mental Retardation (MR is a developmental disability characterized by impairments in adaptive daily life skills and difficulties in social and interpersonal functioning. Since multiple causes may contribute to MR, associated clinical pictures may vary accordingly. Nevertheless, when psychiatric disorders as Treatment Resistant Depression (TRD and/or alcohol abuse co-exist, their proper detection and management is often troublesome, essentially due to a limited vocabulary MR people could use to describe their symptoms, feelings and concerns, and the lack of reliable screening tools. Furthermore, MR people are among the most medicated subjects, with (over prescription of antidepressants and/or typical antipsychotics being the rule rather than exception. Thus, treatment resistance or even worsening of depression, constitute frequent occurrences. This report describes the case of a person with MR who failed to respond to repetitive trials of antidepressant monotherapies, finally recovering using aripiprazole to fluvoxamine augmentation upon consideration of a putative bipolar diathesis for “agitated” TRD. Although further controlled investigations are needed to assess a putative bipolar diathesis in some cases of MR associated to TRD, prudence is advised in the long-term prescription of antidepressant monotherapies in such conditions.

  10. Do Juries Let Some Defendants Get Away With Murder? Examining the Effect of Pre-Cognitive Decision Making on Insanity Defense Cases

    OpenAIRE

    Resnikoff, Theodore

    2017-01-01

    This research examines the effect of bias on Insanity Defense cases, theorizing that juries treat Insanity Defense cases differently from other types of cases because they are ill equipped to contemplate them. Insanity Defense cases are statistically rare, yet the success rate of such defenses is surprisingly high. This thesis presents a qualitative argument examining reasons for the success of the Insanity Defense, explains the neuroscience, and effect of group dynamics on decision making, a...

  11. Individual differences in eyewitness identification accuracy between sequential and simultaneous line-ups: consequences for police practice and jury decisions

    Directory of Open Access Journals (Sweden)

    Dominic Willmott

    2016-10-01

    Full Text Available Background Although previous research has indicated that sequential line-up procedures result in fewer mistaken identifications, this was found to be at the expense of accurate identifications more typical within simultaneous procedures. Hence, there remains a lack of agreement about which procedure is superior, and the interaction such procedures have with eyewitness confidence. The interaction between witness demographics and identification accuracy also remains unclear. Participants and procedure The opportunistic sample, consisting of 60 people from the general population, was divided randomly into two experimental conditions: simultaneous (SIM and sequential (SEQ. Participants in the sequential procedure observed 12 photographs, one at a time, deciding if they believed the suspect to be the person shown in the current photograph and unable to return to a given picture once they decided the individual shown was not the suspect described. Participants in the simultaneous condition were shown all 12 photographs concurrently and asked to determine which, if any, of the photographs was the suspect described. Results No significant differences were found in identification accuracy between line-up procedures, but significant differences in confidence levels between the two line-up procedures were found. Additionally, analysis of demographic features showed previous line-up experience to be significantly associated with identification accuracy. Conclusions The present research provides new insight into the interaction of eyewitness confidence between line-up techniques, offering an alternative explanation of witness confidence as well as procedural fairness. Evidence of practice effects increasing the accuracy of identification provides beneficial future implications for police line-up procedures and safer jury decisions, often reliant on identification evidence.

  12. Obtaining consumer perspectives using a citizens' jury: does the current country of origin labelling in Australia allow for informed food choices?

    Science.gov (United States)

    Withall, Elizabeth; Wilson, Annabelle M; Henderson, Julie; Tonkin, Emma; Coveney, John; Meyer, Samantha B; Clark, Jacinta; McCullum, Dean; Ankeny, Rachel; Ward, Paul R

    2016-12-09

    Contemporary food systems are vast and complex, creating greater distance between consumers and their food. Consequently, consumers are required to put faith in a system of which they have limited knowledge or control. Country of origin labelling (CoOL) is one mechanism that theoretically enables consumer knowledge of provenance of food products. However, this labelling system has recently come under Australian Government review and recommendations for improvements have been proposed. Consumer engagement in this process has been limited. Therefore this study sought to obtain further consumer opinion on the issue of CoOL and to identify the extent to which Australian consumers agree with Australian Government recommendations for improvements. A citizens' jury was conducted with a sample of 14 South Australian consumers to explore their perceptions on whether the CoOL system allows them to make informed food choices, as well as what changes (if any) need to be made to enable informed food choices (recommendations). Overall, jurors' perception of usefulness of CoOL, including its ability to enable consumers to make informed food choices, fluctuated throughout the Citizens' Jury. Initially, the majority of the jurors indicated that the labels allowed informed food choice, however by the end of the session the majority disagreed with this statement. Inconsistencies within jurors' opinions were observed, particularly following delivery of information from expert witnesses and jury deliberation. Jurors provided recommendations for changes to be made to CoOL, which were similar to those provided in the Australian Government inquiry. Consumers in this study engaged with the topical issue of CoOL and provided their opinions. Overall, consumers do not think that the current CoOL system in Australia enables consumers to make informed choices. Recommendations for changes, including increasing the size of the label and the label's font, and standardising its position, were made.

  13. Moskva pisaraid ei usu : 5. Venemaa rahvuslik teatrifestival "Zolotaja Maska" 10. märtsist 5. aprillini 1999 Moskvas / Juri Ljubimov, Kadi Herkül ; interv. Olga Jero

    Index Scriptorium Estoniae

    Ljubimov, Juri, 1917-2014

    1999-01-01

    Vaadeldakse lavastusi - A. Tshehhovi "Tatjana Repina" (lav. Valeri Fokin), W. Shakespeare'i "Talvemuinasjutt" (lav. Declan Donnellan), A. Ostrovski "Äike" (lav.Henrietta Janovskaja), A. Krutshjonõhhi "Võit päikese üle" (lav. Aleksandr Ponomarjov), W. Gombrowiczi "Iwona, Burgundia printsess" (lav. Oleg Rõbkin) ja H. Pinteri "Majahoidja" (lav. Juri Butussov)

  14. Trial-Based Thought Record (TBTR): preliminary data on a strategy to deal with core beliefs by combining sentence reversion and the use of analogy with a judicial process.

    Science.gov (United States)

    Oliveira, Irismar Reis de

    2008-03-01

    To propose the Trial-Based Thought Record, a modified, 7-column thought record addressing core beliefs by sentence reversion and the analogy to a trial. Clients (n = 30) participated in a simulation of a trial and exhibited shifts in their adherence to core beliefs and in the intensity of corresponding emotions after each step (investigation, prosecutor s plea, defense attorney s plea, prosecutor s second plea, defense attorney s second plea, and jury verdict) during a session. Significant mean reductions existed between percent values after investigation (taken as baseline) and defense attorney s plea (p < 0.001), and after the jury s verdict, either in beliefs (p < 0.001) or in intensity of emotions (p < 0.001). Significant differences also emerged between the defense attorney s first and second pleas (p = 0.009) and between the defense attorney s second plea and jury s verdict concerning core beliefs (p = 0.005) and emotions (p = 0.02). Trial-Based Thought Record may at least temporarily help patients constructively reduce attachment to negative core beliefs and corresponding emotions.

  15. What difference do brain images make in US criminal trials?

    Science.gov (United States)

    Hardcastle, Valerie Gray; Lamb, Edward

    2018-05-09

    One of the early concerns regarding the use of neuroscience data in criminal trials is that even if the brain images are ambiguous or inconclusive, they still might influence a jury in virtue of the fact that they appear easy to understand. By appearing visually simple, even though they are really statistically constructed maps with a host of assumptions built into them, a lay jury or a judge might take brain scans to be more reliable or relevant than they actually are. Should courts exclude brain scans for being more prejudicial than probative? Herein, we rehearse a brief history of brain scans admitted into criminal trials in the United States, then describe the results of a recent analysis of appellate court decisions that referenced 1 or more brain scans in the judicial decision. In particular, we aim to explain how courts use neuroscience imaging data: Do they interpret the data correctly? Does it seem that scans play an oversized role in judicial decision-making? And have they changed how criminal defendants are judged? It is our hope that in answering these questions, clinicians and defence attorneys will be able to make better informed decisions regarding about how to manage those incarcerated. © 2018 John Wiley & Sons, Ltd.

  16. Commentary: Pursuing justice in death penalty trials.

    Science.gov (United States)

    Watson, Clarence; Eth, Spencer; Leong, Gregory B

    2012-01-01

    The capital trial, by its nature, is fraught with emotionally disturbing elements that jurors must face when deciding the ultimate fate of a guilty defendant. A confluence of mitigating and aggravating factors influences a capital jury's decision to impose a sentence of death. The presence or absence of defendant remorse in these cases may make all the difference in whether a capital defendant's life is spared. This commentary examines the onerous emotional toll encountered by capital jurors in light of the findings of Corwin and colleagues regarding defendant remorse and juror's need for affect. The commentary also presents practical and ethics-related considerations that should be kept in mind when reflecting on their study.

  17. Arbitrariness and the death penalty: how the defendant's appearance during trial influences capital jurors' punishment decision.

    Science.gov (United States)

    Antonio, Michael E

    2006-01-01

    This paper examines the impact of the defendant's appearance during the trial on capital jurors' punishment decision. The data used in this analysis were gathered by the Capital Jury Project (CJP), a national program of research on the decision-making of capital jurors. A series of multivariate logistic regression analyses were conducted using four aggravating circumstances related to the killing and eight defendant appearance variables as predictors of jurors' punishment decision at three points during the capital trial: (1) after the punishment phase ended, but before formal deliberation began; (2) when the first vote was taken on punishment at jury deliberations; and (3) at the final vote on punishment. Results indicated that when the defendant appeared emotionally involved during the trial (i.e. sorry and sincere) jurors either favored a life sentence or were undecided about punishment; however, when the defendant appeared emotionally uninvolved during the trial (i.e. bored) jurors either sought a death sentence or remained undecided. Policy implications will be discussed. Copyright (c) 2006 John Wiley & Sons, Ltd.

  18. The duty to give reasons as a guarantee for a fair trial under the sight of the European Court of Human Rights

    Directory of Open Access Journals (Sweden)

    Marcella Alves Mascarenhas Nardelli

    2015-06-01

    Full Text Available This paper aims to define the outlines of the judicial duty to provide reasons for their decisions in its theoretical aspect - according to contemporary procedural knowledge -, as well as to establish its importance for the concretion of a fair trial. At the same time, the duty to give reasons will be analyzed in a practical perspective according to the case-law of the European Court of Human Rights, with a special emphasis in the case Taxquet v. Belgium and its impact on Jury Trials.

  19. Role of anti-angiogenesis therapy in the management of hepatocellular carcinoma: The jury is still out

    Institute of Scientific and Technical Information of China (English)

    Hong; Sun; Man-Sheng; Zhu; Wen-Rui; Wu; Xiang-De; Shi; Lei-Bo; Xu

    2014-01-01

    As the leading cause of disease-related deaths,cancer is a major public health threat worldwide.Surgical resection is still the first-line therapy for patients with early-stage cancers.However,postoperative relapse and metastasis remain the cause of 90%of deaths of patients with solid organ malignancies,including hepatocellular carcinoma(HCC).With the rapid development of molecular biology techniques in recent years,molecularly targeted therapies using monoclonal antibodies,small molecules,and vaccines have become a milestone in cancer therapeutic by significantly improv-ing the survival of cancer patients,and have opened a window of hope for patients with advanced cancer.Hypervascularization is a major characteristic of HCC.It has been reported that anti-angiogenic treatments,which inhibit blood vessel formation,are highly effective for treating HCC.However,the efficacy and safety of anti-angiogenesis therapies remain controversial.Sorafenib is an oral multikinase inhibitor with antiproliferative and anti-angiogenic effects and is the first molecular target drug approved for the treatment of advanced HCC.While sorafenib has shown promising therapeutic effects,substantial evidence of primary and acquired resistance to sorafenib has been reported.Numerous clinical trials have been conducted to evaluate a large number of molecularly targeted drugs for treating HCC,but most drugs exhibited less efficacy and/or higher toxicity compared to sorafenib.Therefore,understanding the mechanism(s)underlying sorafenib resistance of cancer cells is highlighted for efficiently treating HCC.This concise review aims to provide an overview of anti-angiogenesis therapy in the management of HCC and to discuss the common mechanisms of resistance to anti-angiogenesis therapies.

  20. Trial-based psychotherapy and the efficacy of trial-based thought record in changing unhelpful core beliefs and reducing self-criticism.

    Science.gov (United States)

    de Oliveira, Irismar Reis; Hemmany, Curt; Powell, Vania B; Bonfim, Thaís D; Duran, Erica P; Novais, Nilma; Velasquez, Michella; Di Sarno, Elaine; Alves, Gledson L; Cesnik, Joici A

    2012-03-01

    The best prevention against relapse results when patients are taught to restructure negative core beliefs (CBs). Efficacy of the trial-based thought record (TBTR) in decreasing the credit given by patients to negative CBs and corresponding emotions was evaluated. Patients (n = 166) were submitted to a simulation of a legal trial to assess their adherence to negative CBs and corresponding emotions after each cognitive therapy technique incorporated by TBTR. Significant reductions existed in percent values after the first and second defense attorney pleas, as well as after jury's verdict and initial preparation for the appeal (p < 0.001), relative to the investigation phase. Significant differences also emerged between the defense attorney's first and second pleas and between the defense attorney's second plea and jury's verdict, as well as preparation for the appeal (p < 0.001). There was no significant difference between percentages presented by patients submitted to TBTR used in the empty chair format relative to the conventional format. Similarly, there was no difference between outcomes, regardless of therapists' level of exposure to TBTR. TBTR may help patients reduce attachment to negative CBs and corresponding emotions. Outcomes were significantly favorable regardless of the format use and therapists' level of exposure to TBTR.

  1. Clinical Trials

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    Full Text Available ... Clinical Trials About Clinical Trials Clinical trials are research studies that explore whether a medical strategy, treatment, or ... humans. What Are Clinical Trials? Clinical trials are research studies that explore whether a medical strategy, treatment, or ...

  2. Jury still out on uranium

    International Nuclear Information System (INIS)

    Mudd, G.

    1999-01-01

    The author, a volunteer researcher on nuclear issues for the Australian Conservation Foundation and Friends of the Earth, claims that opposition to nuclear industry in Australia is based on scientific evidence, moral arguments and year of experience in Australia and globally. He stated that as result on uranium mining the radioactivity on the respective sites increases and that these small increases in background radiation are linked to increases in cancer rates. New scientific evidence also suggests that exposure to low levels of ionising nuclear radiation increases cancer risks. Sites such as Chernobyl in the Ukraine, Sellafield in the United Kingdom, Radium Hill and Maralinga in South Australia and Three Mile Island in America are given as examples of increased health problems arising from nuclear activities. (author) Copyright (1999) Australasian Science

  3. Olestra? The Jury's Still Out

    Science.gov (United States)

    Doyle, Ellin

    1997-04-01

    Although it has been more than a year since the FDA approved the use of olestra in certain foods, this fat substitute, a mixture of sucrose polyesters, is still controversial. It would seem that a fat substitute that is heat stable and has an acceptable flavor and texture would be welcomed enthusiastically in a country where increasing numbers of people, young and old, exceed their ideal body weight. Obesity and diets containing high levels of fat have been linked to numerous health problems, including cardiovascular diseases, certain types of cancer, and adult-onset diabetes; they may also exacerbate some chronic problems such as arthritis in joints of the lower extremities. Nevertheless, some scientists and consumer groups question olestra's safety and usefulness.

  4. Clinical Trials

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    Full Text Available ... questions and clinical trials. Optimizing our Clinical Trials Enterprise NHLBI has a strong tradition of supporting clinical ... multi-pronged approach to Optimize our Clinical Trials Enterprise that will make our clinical trials enterprise even ...

  5. Clinical Trials

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    Full Text Available ... to-kol). This plan explains how the trial will work. The trial is led by a principal ... for the clinical trial. The protocol outlines what will be done during the clinical trial and why. ...

  6. Clinical Trials

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    Full Text Available ... take part in a clinical trial. When researchers think that a trial's potential risks are greater than ... care costs for clinical trials. If you're thinking about taking part in a clinical trial, find ...

  7. Clinical Trials

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    Full Text Available ... of clinical trials contribute to medical knowledge and practice. Why Clinical Trials Are Important Clinical trials are ... earlier than they would be in general medical practice. This is because late-phase trials have large ...

  8. Clinical Trials

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    Full Text Available ... clinical trials contribute to medical knowledge and practice. Why Clinical Trials Are Important Clinical trials are a ... will be done during the clinical trial and why. Each medical center that does the study uses ...

  9. Clinical Trials

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    Full Text Available ... medical strategy, treatment, or device is safe and effective for humans. What Are Clinical Trials? Clinical trials ... and Centers sponsor clinical trials. Many other groups, companies, and organizations also sponsor clinical trials. Examples include ...

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    Full Text Available ... and treatments that work best. How Clinical Trials Work If you take part in a clinical trial, ... kol). This plan explains how the trial will work. The trial is led by a principal investigator ( ...

  11. Clinical Trials

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    Full Text Available ... Trial Protocol Each clinical trial has a master plan called a protocol (PRO-to-kol). This plan explains how the trial will work. The trial ... clinical trial; and detailed information about the treatment plan. Eligibility Criteria A clinical trial's protocol describes what ...

  12. Juror Judgments and Discussion: Effect of Presentation and Memory Factors on Polarization.

    Science.gov (United States)

    Kaplan, Martin F.; Miller, Charles E.

    Mock juries of six females each listened to a tape-recording of facts in a courtroom trial. Twelve juries heard guilt-appearing facts, and twelve heard innocent-appearing facts. In half the juries hearing each type of trial, jurors heard the facts in the same (Homogeneous) order; in the remaining juries, each of the six jurors heard the facts in a…

  13. Clinical Trials

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    Full Text Available ... protocol affect the trial's results. Comparison Groups In most clinical trials, researchers use comparison groups. This means ... study before you agree to take part. Randomization Most clinical trials that have comparison groups use randomization. ...

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    Full Text Available ... clinical trials are vital to the process of improving medical care. Many people volunteer because they want ... care costs for clinical trials. If you're thinking about taking part in a clinical trial, find ...

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    Full Text Available ... or vulnerable patients (such as children). A DSMB's role is to review data from a clinical trial ... a Clinical Trial If you're interested in learning more about, or taking part in, clinical trials, ...

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    Full Text Available ... Clinical Trials About Clinical Trials Clinical trials are research studies that explore whether a medical strategy, treatment, ... required to have an IRB. Office for Human Research Protections The U.S. Department of Health and Human ...

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    Full Text Available ... Trials About Clinical Trials Clinical trials are research studies that explore whether a medical strategy, treatment, or ... and Clinical Studies Web page. Children and Clinical Studies Learn more about Children and Clinical Studies Importance ...

  18. Clinical Trials

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    Full Text Available ... criteria differ from trial to trial. They include factors such as a patient's age and gender, the ... bias. "Bias" means that human choices or other factors not related to the protocol affect the trial's ...

  19. Clinical Trials

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    Full Text Available ... more information about eligibility criteria, go to "How Do Clinical Trials Work?" Some trials enroll people who ... for adults. For more information, go to "How Do Clinical Trials Protect Participants?" For more information about ...

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    Full Text Available ... you agree to take part in the trial. Talk with your doctor about specific trials you're ... part in a clinical trial is your decision. Talk with your doctor about all of your treatment ...

  1. Clinical Trials

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    Full Text Available ... any clinical trial before you agree to take part in the trial. Talk with your doctor about specific trials you're interested in. For a list of questions to ask your doctor and the ...

  2. Clinical Trials

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    Full Text Available ... and treatments that work best. How Clinical Trials Work If you take part in a clinical trial, ... study? How might this trial affect my daily life? Will I have to be in the hospital? ...

  3. Clinical Trials

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    Full Text Available ... and treatments that work best. How Clinical Trials Work If you take part in a clinical trial, ... from a study at any time, for any reason. Also, during the trial, you have the right ...

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    Full Text Available ... or device is safe and effective for humans. What Are Clinical Trials? Clinical trials are research studies ... parents, clinicians, researchers, children, and the general public. What to Expect During a clinical trial, doctors, nurses, ...

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    Full Text Available ... under way. For example, some trials are stopped early if benefits from a strategy or treatment are ... stop a trial, or part of a trial, early if the strategy or treatment is having harmful ...

  6. Post-trial obligations - DOI: 10.3395/reciis.v2.Sup1.210en

    Directory of Open Access Journals (Sweden)

    Doris Schroeder

    2008-12-01

    Full Text Available In its essence, post-trial obligations describe a duty by research sponsors to provide a successfully tested drug to research participants who took part in the relevant clinical trials after the trial has been concluded. In some instances, this duty is extended beyond the research participants. This article is divided into three main parts. The first part outlines the legal basis for post-trial obligations by looking at international guidelines, including those issued by the World Medical Association. National legislation is exemplified through resolutions and guidelines issued by Brazil and South Africa respectively. The second part analyses the ethical foundation for post-trial obligations, in particular the attempt to minimize exploitation of research subjects. The third part raises obstacles and challenges for the implementation of post-trial obligations. The jury is still out on whether post-trial obligations in the form of access to drugs for clinical trial participants is the best, or even a good way, to avoid exploitation in medical research.

  7. Clinical Trials

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    Full Text Available ... need to travel or stay in hospitals to take part in clinical trials. For example, the National Institutes of Health Clinical Center in ... Maryland, runs clinical trials. Many other clinical trials take place in medical centers and ... trial can have many benefits. For example, you may gain access to new treatments before ...

  8. Clinical Trials

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    Full Text Available ... of clinical trials contribute to medical knowledge and practice. Why Clinical Trials Are Important Clinical trials are a key ... Enterprise NHLBI has a strong tradition of supporting clinical trials that have not only shaped medical practice around the world, but have improved the health ...

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    Full Text Available ... clinical trials. If you're thinking about taking part in a clinical trial, find out ahead of time about costs and coverage. You should learn about the risks and benefits of any clinical trial before you agree to take part in the trial. Talk with your doctor about ...

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    Full Text Available ... medical knowledge and practice. Why Clinical Trials Are Important Clinical trials are a key research tool for ... other for moderate persistent asthma. The results provided important treatment information for doctors and patients. The results ...

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    Full Text Available ... groups, companies, and organizations also sponsor clinical trials. Examples include Government Agencies, such as the U.S. Departments ... sponsor trials that test principles or strategies. For example, one NHLBI study explored whether the benefits of ...

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    Full Text Available ... Departments of Defense and Veterans Affairs; private companies; universities; and nonprofit organizations. NIH Institutes and Centers (including ... our campus or trials NIH has sponsored at universities, medical centers, and hospitals. ClinicalTrials.gov View a ...

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    Full Text Available ... Entire Site NHLBI Entire Site Health Topics News & Resources Intramural Research ... or device is safe and effective for humans. What Are Clinical Trials? Clinical trials are research ...

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    Full Text Available ... sponsor clinical trials. Many other groups, companies, and organizations also sponsor clinical trials. Examples include Government Agencies, ... and Veterans Affairs; private companies; universities; and nonprofit organizations. NIH Institutes and Centers (including the NHLBI) usually ...

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    Full Text Available ... decisionmaking. The purpose of clinical trials is research, so the studies follow strict scientific standards. These standards ... otherwise. The purpose of clinical trials is research, so the studies follow strict scientific standards. These standards ...

  16. Clinical Trials

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    Full Text Available ... identified earlier than they would be in general medical practice. This is because late-phase trials have large ... supporting clinical trials that have not only shaped medical practice around the world, but have improved the health ...

  17. Clinical Trials

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    Full Text Available ... Working at the NHLBI Contact and FAQs Accessible Search Form Search the NHLBI, use the drop down list to ... to learn more about clinical research and to search for clinical trials: NHLBI Clinical Trials Browse a ...

  18. Clinical Trials

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    Full Text Available ... people who fit the patient traits for that study (the eligibility criteria). Eligibility criteria differ from trial to trial. They include factors such as a patient's age and gender, the type and stage of disease, and whether ...

  19. Clinical Trials

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    Full Text Available ... medical strategy, treatment, or device is safe and effective for humans. What Are Clinical Trials? Clinical trials ... medical strategy, treatment, or device is safe and effective for humans. These studies also may show which ...

  20. Clinical Trials

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    Full Text Available ... and treatments that work best. How Clinical Trials Work If you take part in a clinical trial, ... care providers might be part of your treatment team. They will monitor your health closely. You may ...

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  6. Aleksandro-Nevski sobor / Juri Nikiforov

    Index Scriptorium Estoniae

    Nikiforov, Juri

    2002-01-01

    Tallinna Aleksander Nevski peakiriku ehituslugu: arhitekt Mihhail Preobrazhenski. Mosaiikpannoode looja on akadeemik A. Frolov, ikonostaasid (puit) teostas Pjotr Abrosimov (?), ikoonimaalid - akadeemik Aleksandr Novoskoltsev ja tema töökoda, vitraažid - Emil Schteinke (?), maalid - Mihhail Vassiljev ja Aleksandr Blazov, seinamaalingud - Grigori Prokofjev. 2002. a. lisandusid kaks Andrei Lobanovi vitraaži

  7. Tort Law and the Civil Jury.

    Science.gov (United States)

    Pittman, Keith A.

    1997-01-01

    Briefly reviews the historical developments of tort law and identifies some of its main component. Tort law concerns wrongful acts (not involving a breach of contract) that may result in a civil action. Major areas include personal injury and wrongful death, intentional torts, negligence, professional malpractice, misrepresentation, and libel.…

  8. The Consumer as 'Voter', 'Judge' and 'Jury'

    DEFF Research Database (Denmark)

    Schwarzkopf, Stefan

    2011-01-01

    . It was, however, the development of market research methods during the 1930s and 1940s, which provided the crucial backdrop for the sudden rise to prominence of an idea that assumes that consumers dictate what is produced through their ‘‘votes,’’ that is, daily choices. Innovations in the measurement...

  9. Lomonossovi "Iiobi valitud oodist" / Juri Lotman

    Index Scriptorium Estoniae

    Lotman, Juri, 1922-1993

    2007-01-01

    17.-18. saj. Lääne-Euroopa ja Venemaa ideoloogilisest olukorrast M. Lomonossovi luuletuse "Iiobist valitud ood" alusel. Lisa: Lomonossov, Mihhail. Oda, võbrannaja iz Iovõ. Lk. 119-123. Varem ilm.: Lotman, J. M. Izbrannõje stati v treh tomah, t. II. - Tallinn, 1992. Lk. 29-39

  10. Tüketici Sorunları Hakem Heyeti Raporları Ve Tüketici Davranışları: Odunpazarı Örneği / Ground Jury of the Consumer Issues Reports and Consumer Behavior: Odunpazarı Example

    Directory of Open Access Journals (Sweden)

    Muhittin ADIYAMAN

    2012-12-01

    Full Text Available Bu çalışma 4077 Sayılı Tüketicinin Korunması Hakkında Kanun’la hukuk sistemimize kazandırılan Tüketici Sorunları Hakem Heyetlerinin işleyişi, şikâyetlerin alınma ve değerlendirme sürecine dair 358.566 nüfuslu Odunpazarı ilçesinde tüketici sorunlarına üretilen çözümlerin boyutu ve tüketici davranışlarını sunmayı amaçlayan bir uygulama örneğidir. Çalışmamız; Tüketici Sorunları Hakem Heyeti Yönetmeliğinin 25. Maddesi gereği dörder aylık dönemler hâlinde hazırlanan Eskişehir Odunpazarı Tüketici Sorunları Hakem Heyeti’nin 2009-2012 yılları arasındaki faaliyet raporlarında belirtilen müracaat sayıları, tüketicinin lehine ve aleyhine olarak sonuçlanan karar sayıları ve şikâyetlerin türünü kapsamaktadır. Tüketici Sorunları Hakem Heyetleri aynı yönetmelik çerçevesinde çalışmalarına rağmen şikâyetlerin alınma ve değerlendirme sürecinde uygulama farklılıkları olabilmektedir. Bu farklılıklardan biri de Müdürlüğümüzün iş akışını hızlandırmak amacıyla geliştirdiği bir yazılımla şikâyetleri alıp değerlendirmesidir. Tüketici Sorunları Hakem Heyetlerinin raporlarına ait ülke çapında sistemli bir veri tabanı olmalı; Hakem Heyetlerinin uygulamalarına ve karar sonuçlarına yönelik karşılaştırmaların yapılarak, tüketici sorunlarının detaylı tetkiki sonucu üretilecek çözümlerle tüketici mağduriyetlerinin önüne geçilmelidir. Ground Jury of the Consumer Issues Reports and Consumer Behavior: Odunpazarı Example This study is an example of application with Law No. 4077 on Consumer Protection offered to judicial system functioning ground jury of the consumer Issues, about the process complaints of inclusion and assessment aims to provide generated solutions to consumer problems and consumer behavior of Odunpazarı district with 358.566 population. Our study contains; with the regulation 25 on ground jury of the consumer

  11. Clinical Trials

    Medline Plus

    Full Text Available ... an important gap in information and education for parents, clinicians, researchers, children, and the general public. What to Expect During a clinical trial, doctors, nurses, social workers, and other health care providers might be part of your treatment team. ...

  12. Clinical Trials

    Medline Plus

    Full Text Available ... taking the same treatment the same way. These patients are closely watched by Data and Safety Monitoring Boards. Even if you don't directly ... risk procedures (such as gene therapy) or vulnerable patients (such as ... trial for safety problems or differences in results among different groups. ...

  13. The Trial

    Science.gov (United States)

    Bryant, Jen

    2004-01-01

    Growing up in Flemington, New Jersey, put Jen Bryant in the heart of the lore behind the Lindbergh baby kidnapping. Family stories of the events of the day and extensive research led to "The Trial," a novel in verse. The first several parts of this novel are included here.

  14. Clinical Trials

    Medline Plus

    Full Text Available Skip to main content U.S. Department of Health & Human Services Health Topics Health Topics A-Z Clinical Trials Publications and Resources Health Education and Awareness The Science Science Home Blood Disorders and Blood Safety Sleep ...

  15. Clinical Trials

    Medline Plus

    Full Text Available ... treatments produce better results for certain illnesses or groups of people; look at the best age and frequency for doing screening tests, such as mammography; and compare two or more screening tests to see which test ... Some companies and groups sponsor clinical trials that test the safety of ...

  16. Clinical Trials

    Medline Plus

    Full Text Available ... patient has had certain treatments or has other health problems. Eligibility criteria ensure that new approaches are tested ... public. What to Expect During a clinical trial, doctors, nurses, social workers, and other health care providers might be part of your treatment ...

  17. Clinical Trials

    Medline Plus

    Full Text Available ... This shows how the approach affects a living body and whether it's harmful. However, an approach that works well in the lab or animals doesn't always work well in people. Thus, research in humans is needed. For safety purposes, clinical trials start ...

  18. Clinical Trials

    Medline Plus

    Full Text Available ... edge approaches, such as gene therapy or new biological treatments. Health insurance and health care providers don't ... of a trial, early if the strategy or treatment is having harmful effects. Food and Drug Administration In the United States, the Food and ...

  19. Clinical Trials

    Medline Plus

    Full Text Available ... U.S. Departments of Defense and Veterans Affairs; private companies; universities; and nonprofit organizations. NIH Institutes and Centers (including the NHLBI) usually sponsor trials that test principles or strategies. For example, one NHLBI study explored whether the ...

  20. Clinical Trials

    Medline Plus

    Full Text Available ... to main content U.S. Department of Health & Human Services Health Topics Health Topics A-Z Clinical Trials Publications and Resources Health Education and Awareness The Science Science Home Blood Disorders and Blood Safety Sleep Science and ...

  1. Clinical Trials

    Medline Plus

    Full Text Available ... protect patients and help produce reliable study results. Clinical trials are one of the final stages of a long and careful research process. The process often begins in a laboratory (lab), where scientists first develop and test new ...

  2. Clinical Trials

    Medline Plus

    Full Text Available ... benefits of lowering high blood pressure in the elderly outweighed the risks. Other examples of clinical trials ... child to enroll. Also, children aged 7 and older often must agree (assent) to take part ... about how you feel. Some people will need to travel or stay in hospitals ...

  3. Clinical Trials

    Medline Plus

    Full Text Available ... Trials Publications and Resources Health Education and Awareness The Science Science Home Blood Disorders and Blood Safety Sleep ... Activity Population and Epidemiology Studies Women’s Health All Science A-Z Grants ... in the Press Research Features All Events Past Events Upcoming ...

  4. Clinical Trials

    Medline Plus

    Full Text Available ... safe a treatment is or how well it works. Children (aged 18 and younger) get special protection as research subjects. Almost always, parents must give legal consent for their child to take part in a clinical trial. When ...

  5. Clinical Trials

    Medline Plus

    Full Text Available ... As a result, the U.S. Food and Drug Administration now recommends never using HT to prevent heart disease. When HT is used for menopausal symptoms, it should be taken only at the smallest dose and for the shortest time possible. Clinical trials, like the two described above, ...

  6. Clinical Trials

    Medline Plus

    Full Text Available ... Diseases Heart and Vascular Diseases Precision Medicine Activities Obesity, Nutrition, and Physical Activity Population and Epidemiology Studies ... include factors such as a patient's age and gender, the type and stage of disease, ... helps ensure that any differences observed during a trial are due to the ...

  7. Clinical Trials

    Medline Plus

    Full Text Available ... an important gap in information and education for parents, clinicians, researchers, children, and the general public. What to Expect During ... trial's potential risks are greater than minimal, both parents must give permission for their child to enroll. Also, children aged 7 and older ...

  8. Clinical Trials

    Medline Plus

    Full Text Available ... Wide Range of Audiences The Children and Clinical Studies Program has been successfully developed and evaluated to fill an important gap in information and education for parents, clinicians, researchers, children, and the general public. What to Expect During a clinical trial, doctors, ...

  9. Clinical Trials

    Medline Plus

    Full Text Available ... approach that works well in the lab or animals doesn't always work well in people. Thus, research in humans is needed. For safety purposes, clinical trials start with small groups of patients to find out whether a ...

  10. Textbook of clinical trials

    National Research Council Canada - National Science Library

    Day, Simon; Machin, David; Green, Sylvan B

    2006-01-01

    ... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xix INTRODUCTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 1 The Development of Clinical Trials Simon...

  11. Types of Cancer Clinical Trials

    Science.gov (United States)

    Information about the several types of cancer clinical trials, including treatment trials, prevention trials, screening trials, supportive and palliative care trials. Each type of trial is designed to answer different research questions.

  12. Understanding Clinical Trials

    Science.gov (United States)

    Watch these videos to learn about some basic aspects of cancer clinical trials such as the different phases of clinical trials, methods used to protect patient safety, and how the costs of clinical trials are covered.

  13. A petition to Mr Peel: Gideon Mantell and the trial of Hannah Russell.

    Science.gov (United States)

    Flanagan, R J; Watson, K D

    2009-07-01

    In the summer of 1826, Hannah Russell was tried for petty treason, viz. the murder of her husband, Benjamin Russell, by poisoning. Their lodger, Daniel Leney, was indicted as her accomplice. The exact circumstances surrounding the death were unclear but Hannah was known to have purchased white arsenic (arsenious oxide). A local surgeon, Thomas Evans, supported at the post-mortem examination by two further surgeons, not only reported severe corrosion of the gastrointestinal tract, but also the recovery of nearly an eighth of an ounce of arsenic from the victim's stomach. Both accused were convicted and sentenced to death. Leney was executed, but Hannah Russell was respited because the trial judge, Sir Robert Graham, had doubts as to a direction he had given to the jury. The surgeon and paleontologist Gideon Mantell took up her case, stressing that death from arsenic could not have taken place as quickly as was alleged and maintaining that the chemical evidence of arsenic poisoning was inconclusive. He gained the support of some eminent chemists and physicians. Subsequently, forensic toxicologists [Sir] Robert Christison and Alfred Swaine Taylor pointed out that Mantell's arguments as to the possible time to death in arsenic poisoning were quite wrong. Moreover, Evans gave details of the analyses he and his colleagues had undertaken to Christison, who pronounced the findings sound, as indeed did Mantell after Evans and his colleagues published details of their investigations in the Sussex Advertiser. Papers in The National Archives show that Hannah was pardoned for the offence for which she was indicted, leaving it open to prefer a lesser charge. That this was never done may have been due to Mantell's campaign, at least in part, but the pardon she did receive was due to the concern of the trial judge as to the implications of the evidence presented at trial.

  14. Clinical trials of homoeopathy.

    Science.gov (United States)

    Kleijnen, J; Knipschild, P; ter Riet, G

    1991-01-01

    OBJECTIVE--To establish whether there is evidence of the efficacy of homoeopathy from controlled trials in humans. DESIGN--Criteria based meta-analysis. Assessment of the methodological quality of 107 controlled trials in 96 published reports found after an extensive search. Trials were scored using a list of predefined criteria of good methodology, and the outcome of the trials was interpreted in relation to their quality. SETTING--Controlled trials published world wide. MAIN OUTCOME MEASURES--Results of the trials with the best methodological quality. Trials of classical homoeopathy and several modern varieties were considered separately. RESULTS--In 14 trials some form of classical homoeopathy was tested and in 58 trials the same single homoeopathic treatment was given to patients with comparable conventional diagnosis. Combinations of several homoeopathic treatments were tested in 26 trials; isopathy was tested in nine trials. Most trials seemed to be of very low quality, but there were many exceptions. The results showed a positive trend regardless of the quality of the trial or the variety of homeopathy used. Overall, of the 105 trials with interpretable results, 81 trials indicated positive results whereas in 24 trials no positive effects of homoeopathy were found. The results of the review may be complicated by publication bias, especially in such a controversial subject as homoeopathy. CONCLUSIONS--At the moment the evidence of clinical trials is positive but not sufficient to draw definitive conclusions because most trials are of low methodological quality and because of the unknown role of publication bias. This indicates that there is a legitimate case for further evaluation of homoeopathy, but only by means of well performed trials. PMID:1825800

  15. Managing clinical trials

    Directory of Open Access Journals (Sweden)

    Kenyon Sara

    2010-07-01

    Full Text Available Abstract Managing clinical trials, of whatever size and complexity, requires efficient trial management. Trials fail because tried and tested systems handed down through apprenticeships have not been documented, evaluated or published to guide new trialists starting out in this important field. For the past three decades, trialists have invented and reinvented the trial management wheel. We suggest that to improve the successful, timely delivery of important clinical trials for patient benefit, it is time to produce standard trial management guidelines and develop robust methods of evaluation.

  16. Remune trial will stop; new trials planned.

    Science.gov (United States)

    James, J S

    1999-05-21

    A clinical trial using remune, the anti-HIV vaccine developed by the late Dr. Jonas Salk, has been ended. The study is a clinical-endpoint trial which looks for statistically significant differences in AIDS sickness or death between patients who add remune to their treatment regimens versus those who use a placebo. Agouron Pharmaceuticals and the Immune Response Corporation who were conducting the trial announced their decision to stop it after an analysis by the Data Safety Monitoring Board. No differences in clinical endpoints were found and it was projected that continuing the trial would likely not find any. The companies are now planning two new Phase III trials using viral load testing rather than clinical endpoints as study criteria.

  17. 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.

  18. Clinical trial methodology

    National Research Council Canada - National Science Library

    Peace, Karl E; Chen, Ding-Geng

    2011-01-01

    "Now viewed as its own scientific discipline, clinical trial methodology encompasses the methods required for the protection of participants in a clinical trial and the methods necessary to provide...

  19. Hepatitis C: Clinical Trials

    Science.gov (United States)

    ... and Public Home » Hepatitis C » Treatment Decisions Viral Hepatitis Menu Menu Viral Hepatitis Viral Hepatitis Home For ... can I find out about participating in a hepatitis C clinical trial? Many trials are being conducted ...

  20. Understanding noninferiority trials

    Directory of Open Access Journals (Sweden)

    Seokyung Hahn

    2012-11-01

    Full Text Available Noninferiority trials test whether a new experimental treatment is not unacceptably less efficacious than an active control treatment already in use. With continuous improvements in health technologies, standard care, and clinical outcomes, the incremental benefits of newly developed treatments may be only marginal over existing treatments. Sometimes assigning patients to a placebo is unethical. In such circumstances, there has been increasing emphasis on the use of noninferiority trial designs. Noninferiority trials are more complex to design, conduct, and interpret than typical superiority trials. This paper reviews the concept of noninferiority trials and discusses some important issues related to them.

  1. Clinical trial methodology

    National Research Council Canada - National Science Library

    Peace, Karl E; Chen, Ding-Geng

    2011-01-01

    ... in the pharmaceutical industry, Clinical trial methodology emphasizes the importance of statistical thinking in clinical research and presents the methodology as a key component of clinical research...

  2. Comparability of prostate trials

    DEFF Research Database (Denmark)

    Suciu, S; Sylvester, R; Iversen, P

    1993-01-01

    The present overview of advanced prostate cancer required the identification of randomized clinical trials studying the question of maximal androgen blockade versus the classic castration therapy. The heterogeneity of the trials concerned the type of castration (surgical or chemical) and the type...

  3. Conducting clinical trials in Singapore.

    Science.gov (United States)

    Woo, K T

    1999-04-01

    All clinical trials in Singapore will now have to conform to the Medicines (Clinical Trials) Amended Regulations 1998 and the Singapore Good Clinical Practice (GCP) Guidelines 1998. The Medical Clinical Research Committee (MCRC) has been established to oversee the conduct of clinical drug trials in Singapore and together with the legislations in place, these will ensure that clinical trials conducted in Singapore are properly controlled and the well-being of trial subjects are safe guarded. All clinical drug trials require a Clinical Trial Certificate from the MCRC before the trial can proceed. The hospital ethics committee (EC) vets the application for a trial certificate before it is sent to MCRC. The drug company sponsoring the trial has to indemnify the trial investigators and the hospital for negligence arising from the trial. The MCRC, apart from ensuring the safety of trial subjects, has to provide continuing review of the clinical trial and monitors adverse events in the course of the trial. The EC will conduct continuing review of clinical trials. When a non-drug clinical trial is carried out, the EC will ensure that the proposed protocol addresses ethical concerns and meets regulatory requirements for such trials. There is great potential for pharmaceutical Research & Development (R&D) in Singapore. We must develop our skills and infrastructure in clinical trials to enable Singapore to be a regional hub for R&D of drugs in Asia.

  4. Fundamentals of clinical trials

    CERN Document Server

    Friedman, Lawrence M; DeMets, David L; Reboussin, David M; Granger, Christopher B

    2015-01-01

    This is the fifth edition of a very successful textbook on clinical trials methodology, written by recognized leaders who have long and extensive experience in all areas of clinical trials. The three authors of the first four editions have been joined by two others who add great expertise.  Most chapters have been revised considerably from the fourth edition.  A chapter on regulatory issues has been included and the chapter on data monitoring has been split into two and expanded.  Many contemporary clinical trial examples have been added.  There is much new material on adverse events, adherence, issues in analysis, electronic data, data sharing, and international trials.  This book is intended for the clinical researcher who is interested in designing a clinical trial and developing a protocol. It is also of value to researchers and practitioners who must critically evaluate the literature of published clinical trials and assess the merits of each trial and the implications for the care and treatment of ...

  5. Update on TROG trials

    International Nuclear Information System (INIS)

    Joseph, D.

    2001-01-01

    Full text: Validation of treatment methodologies can only be achieved in the context of unambiguous, efficiently managed, randomised and controlled clinical trials. Since 1991, the Trans-Tasman Radiation Oncology Group (TROG) has coordinated over 29 protocols in radiation oncology, including several key randomised controlled trials. The impetus behind TROG is the establishment of an evidence base for particular approaches to radiotherapy and its adjunct use with alternative and complementary treatment methods. As the level of technology incorporated into radiotherapy continues to increase, as the need for improved accuracy in dose assessment increases and as the requirements of realistic quality assurance (QA) for clinical trials becomes more demanding it is imperative that all professionals involved in radiotherapy, including physicists, become actively involved in the QA of trials. This is particularly important for large scale multi-centre trials which intend to prove the benefits of particular treatment approaches on a national or international stage rather then in the context of a single clinic. This talk will: 1. Examine the outcomes of TROG trials to date in terms of the information obtained. 2. Briefly consider current and impending TROG trials and their requirements in terms of clinical and physics input. 3. Examine the results of international clinical trials in terms of the influence they have had on radiotherapy practice and health outcomes, and the advantages they have obtained by consistent co-operation between clinical and technological staff. 4. Consider the benefits of multi-centre clinical trials and the QA controls that are necessary to ensure accuracy of resulting recommendations. Copyright (2001) Australasian College of Physical Scientists and Engineers in Medicine

  6. ClinicalTrials.gov

    Data.gov (United States)

    U.S. Department of Health & Human Services — Provides patients, family members, health care professionals, and members of the public easy access to information on clinical trials for a wide range of diseases...

  7. OARSI Clinical Trials Recommendations

    DEFF Research Database (Denmark)

    Katz, J N; Losina, E; Lohmander, L S

    2015-01-01

    To highlight methodological challenges in the design and conduct of randomized trials of surgical interventions and to propose strategies for addressing these challenges. This paper focuses on three broad areas: enrollment; intervention; and assessment including implications for analysis. For eac...

  8. Cancer clinical trials

    International Nuclear Information System (INIS)

    Scheurlen, A.; Kay, R.; Baum, M.

    1988-01-01

    This book contains the proceedings on Cancer clinical trials: A critical appraisal. Topics covered include: Scientific fundamentals; Heterogeneous treatment effects; On combining information: Historical controls, overviews, and comprehensive cohort studies; and assessment of quality of life

  9. Comparability of prostate trials

    DEFF Research Database (Denmark)

    Suciu, S; Sylvester, R; Iversen, P

    1993-01-01

    The present overview of advanced prostate cancer required the identification of randomized clinical trials studying the question of maximal androgen blockade versus the classic castration therapy. The heterogeneity of the trials concerned the type of castration (surgical or chemical) and the type...... of antiandrogen (flutamide, Anandron, or cyproterone acetate) added to castration. This paper reviews the different types of heterogeneity that might exist among trials that are involved in the overview: study design, randomization procedure, treatment evaluation, statistical evaluation, and data maturity....... In order to overcome these various types of heterogeneity and to compare like with like, the treatment comparison should be stratified a posteriori by question (i.e., type of castration or type of anti-androgen studied) and by study. In this way, one may draw valid conclusions. Of course, those trials...

  10. Falsificationism and clinical trials.

    Science.gov (United States)

    Senn, S J

    1991-11-01

    The relevance of the philosophy of Sir Karl Popper to the planning, conduct and analysis of clinical trials is examined. It is shown that blinding and randomization can only be regarded as valuable for the purpose of refuting universal hypotheses. The purpose of inclusion criteria is also examined. It is concluded that a misplaced belief in induction is responsible for many false notions regarding clinical trials.

  11. Zapredelnõi "Ilmarine" / Juri Mihhaljov ; interv. Boris Tuch

    Index Scriptorium Estoniae

    Mihhaljov, Juri, 1947-

    2004-01-01

    Narva teater "Ilmarine" on Narva linnavalitsuses vastuvõetud otsuste tõttu kaotanud nii dekoratsioonide töökoja kui õiguse kultuurikeskuse "Energeetik" lava soovikohasele kasutusele. Raskustega võideldes otsib-leiab teater võimalusi elus püsida

  12. Climate influences on Vaal River flow | Jury | Water SA

    African Journals Online (AJOL)

    A study of climatic influences on Vaal River discharge, near Johannesburg, South Africa, finds that peak summer flows in the period 1979–2014 coincide with ocean–atmosphere interaction in the east Atlantic. The analysis has three parts: interannual influences by correlation of summer discharge with climate fields, ...

  13. Duell diktaatoriga / Juri Hashtshevatski ; interv. Kelly Grossthal, Maari Ross

    Index Scriptorium Estoniae

    Hashtshevatski, Juri

    2007-01-01

    Tallinnas linastub esimene Eesti-Valgevene ühistöö "Kalinovski väljak", dokumentaalfilm Valgevene kuulsaima režissööri pikalt kestnud ja ohtlikust konfliktist diktaator Lukashenkaga. Poliitilisest olukorrast Valgevenes, president Aleksandr Lukashenkast

  14. Corpus Juris ja Eesti kriminaalõigus / Jaan Sootak

    Index Scriptorium Estoniae

    Sootak, Jaan, 1948-

    1999-01-01

    Euroopa Ühenduse kriminaalõigusest; sanktsioonist, individuaalsest süüksarvamisest ja ebaõigusest Euroopa majanduskriminaalõiguses ning pettuse, altkäemaksu, rahapesu ja kuritegeliku ühenduse kuriteokoosseisudest

  15. Dutch political culture reflected in the mirror of the jury

    NARCIS (Netherlands)

    Griffiths, J.

    1997-01-01

    Observers from Common Law countries are often appalled by what they take to be the essential features of Continental criminal procedure: its secluded, bureaucratic character and the fundamental asymmetry of the parties. These features make them think of the institution with the worst reputation in

  16. Ja rasskazhu vsjo, kak bõlo ... / Juri Tshurbanov

    Index Scriptorium Estoniae

    Tshurbanov, Juri

    1994-01-01

    Venemaa lähiajalugu, stagnatsiooniaeg. Järg Jul/6,7,8,9,13,14,15,16,19,20,21,22,23,26,27,30. lk. 6,3,6,8,6,3,6,4,3,6,3,6,4,3,6,4; Aug/2.,3.,4.,5.,9.,10.,11.,16.,19.,23.,27.,30.,31. lk. 3, Sep/ 3., 7.,9.,21.,28. lk.4,6,6,6,6; Oct/7.,12.,14.,19.,21.,28. lk. 6,6,6,3,6,6; Nov/2.,4.,11.,16.,18. lk. 6

  17. Is the jury still out on PFI contracts?

    Science.gov (United States)

    Baillie, Jonathan

    2012-02-01

    Last September Andrew Lansley claimed that some NHS Trusts occupying PFI healthcare facilities had been 'landed with deals they could not afford', seemingly attributing much of the blame for a scenario where the Department of Health said 22 Trusts in England alone could be at significant financial risk to Labour, which, in the 1990s, greatly expanded a public/private funding partnership originally introduced by the Tories a decade earlier. Two key factors critics claim have put such Trusts 'at risk' are the 'inflexibility' of some PFI contracts, which makes varying terms difficult mid-contract, and the fact that many of the earlier deals were inexpertly negotiated by the 'public sector side'. HEJ editor Jonathan Baillie sought the views of Malcolm Austwick, a partner at top commercial law firm, DAC Beachcroft (see panel below), with extensive experience in the legal complexities of PFI, on whether or not the initiative's 'pros' do indeed outweigh the 'cons'.

  18. The OA Trial Bank

    DEFF Research Database (Denmark)

    van Middelkoop, Marienke; Arden, N K; Atchia, I.

    2016-01-01

    Objective: To evaluate the efficacy of intra-articular (IA) glucocorticoids for knee or hip osteoarthritis (OA) in specific subgroups of patients with severe pain and inflammatory signs using individual patient data (IPD) from existing trials. Design: Randomized trials evaluating one or more IA...... glucocorticoid preparation in patients with knee or hip OA, published from 1995 up to June 2012 were selected from the literature. IPD obtained from original trials included patient and disease characteristics and outcomes measured. The primary outcome was pain severity at short-term follow-up (up to 4 weeks...... Interval 1.50-26.31) when receiving IA glucocorticoid injection compared to placebo. No statistical significant interaction effects were found between inflammatory signs and IA glucocorticoid injections compared to placebo and to tidal irrigation at all follow-up points. Conclusions: This IPD meta...

  19. The CYTONOX trial

    DEFF Research Database (Denmark)

    Gade, Christina; Mikus, Gerd; Christensen, Hanne Rolighed

    2016-01-01

    INTRODUCTION: In Denmark, it is estimated that 3-5% of children are obese. Obesity is associated with pathophysiological alterations that may lead to alterations in the pharmacokinetics of drugs. In adults, obesity was found to influence important drug-metabolising enzyme pathways. The impact...... of obesity-related alterations on drug metabolism and its consequences for drug dosing remains largely unknown in both children and adults. An altered drug metabolism may contribute significantly to therapeutic failure or toxicity. The aim of this trial is to investigate the in vivo activity of CYP3A4, CYP2E......1 and CYP1A2 substrates in obese versus non-obese children. METHODS: The CYTONOX trial is an open-label explorative pharmacokinetic trial. We intend to include 50 obese and 50 non-obese children. The primary end points are: in vivo clearance of CYP3A4, CYP2E1 and CYP1A2 substrates, which...

  20. The FOCUS trial

    DEFF Research Database (Denmark)

    Glenthøj, Louise B; Fagerlund, Birgitte; Randers, Lasse

    2015-01-01

    BACKGROUND: Cognitive deficits are a distinct feature among people at ultra-high risk (UHR) for psychosis and pose a barrier to functional recovery. Insufficient evidence exists on how to ameliorate these cognitive deficits in patients at UHR for psychosis and hence improve daily living and quality...... of life. The aim of the trial is to investigate whether cognitive remediation can improve cognitive and psychosocial function in patients at UHR for psychosis. METHODS: The FOCUS trial (Function and Overall Cognition in Ultra-high risk States) is a randomised, parallel group, observer-blinded clinical...... trial enrolling 126 patients meeting the standardised criteria of being at UHR for psychosis. Patients are recruited from psychiatric in- and outpatient facilities in the Copenhagen catchment area. Patients are randomised to one of the two treatment arms: cognitive remediation plus standard treatment...

  1. The sexual history provisions in the Youth Justice and Criminal Evidence Act 1999--a violation of the right to a fair trial?

    Science.gov (United States)

    Young, G

    2001-07-01

    In response to the Home Office recommendations contained in Speaking Up for Justice (1998) the Youth Justice and Criminal Evidence Act (YJCEA) 1999 introduced a new regime for the conduct of sexual offence trials. Section 41 of the Act, which came into force on 4 December 2000, brings about dramatic changes to the rules on the admissibility of evidence of complainants' sexual behaviour, severely restricting the discretion of trial judges to introduce such evidence or to allow questioning concerning it. This represents a radical new departure that will fundamentally affect an accused's position at trial. Responses to section 41 have predictably been divided given the extremely sensitive nature of this area of the law of evidence and the complex set of social and political issues which are at stake. Many have greeted it as a long overdue reform of a system premised upon outmoded and sexist beliefs concerning women's sexual behaviour which has routinely functioned to admit prejudicial and irrelevant evidence. Others, predominantly within the legal profession, have expressed serious concerns over whether the new law is workable and the extent to which, by potentially excluding critically relevant evidence, it may infringe upon a defendant's right to a fair trial. The quality of the legislation is soon to be tested. On 26 and 27 March 2001 the House of Lords heard an interlocutory appeal in the case of R v. A and were asked to decide if the new provisions, by excluding previous sexual history evidence between the complainant and the defendant, contravened Article 6 of the European Convention of Human Rights. Their Lordships are, at the time of writing, yet to give judgment and the fate of the defendant in question, and several others whose trials have been postponed pending their decision, hangs in the balance. This article seeks to show that the new Act, despite being well-intentioned, does not adopt a coherent or sustainable approach to the relevance of previous

  2. Randomised clinical trial

    DEFF Research Database (Denmark)

    Reimer, C; Lødrup, A; Smith, G

    2016-01-01

    of an alginate (Gaviscon Advance, Reckitt Benckiser, Slough, UK) on reflux symptoms in patients with persistent symptoms despite once daily PPI. MethodsThis was a multicentre, randomised, placebo-controlled, 7-day double-blind trial preceded by a 7-day run-in period. Reflux symptoms were assessed using...

  3. OARSI Clinical Trials Recommendations

    DEFF Research Database (Denmark)

    Kraus, V B; Blanco, F J; Englund, M

    2015-01-01

    The objective of this work was to describe requirements for inclusion of soluble biomarkers in osteoarthritis (OA) clinical trials and progress toward OA-related biomarker qualification. The Guidelines for Biomarkers Working Group, representing experts in the field of OA biomarker research from...

  4. OARSI Clinical Trials Recommendations

    DEFF Research Database (Denmark)

    McAlindon, T. E.; Driban, J. B.; Henrotin, Y.

    2015-01-01

    The goal of this document is to update the original OARSI recommendations specifically for the design, conduct, and reporting of clinical trials that target symptom or structure modification among individuals with knee osteoarthritis (OA). To develop recommendations for the design, conduct...

  5. [Clinical trials in nursing journals].

    Science.gov (United States)

    Di Giulio, Paola; Campagna, Sara; Dimonte, Valerio

    2014-01-01

    Clinical trials are pivotal for the development of nursing knowledge. To describe the clinical trials published in nursing journals in the last two years and propose some general reflections on nursing research. A search with the key-word trial was done on PubMed (2009-2013) on Cancer Nursing, European Journal of Oncology Nursing, International Journal of Nursing Studies, Journal of Advanced Nursing, Journal of Clinical Nursing and Nursing Research. Of 228 trials identified, 104 (45.8%) were published in the last 2 years. Nurses from Asian countries published the larger number of trials. Educational and supportive interventions were the most studied (61/104 trials), followed by clinical interventions (33/104). Samples were limited and most trials are monocentric. A growing number of trials is published, on issues relevant for the nursing profession, however larger samples and multicentric studies would be necessary.

  6. The COLOFOL trial

    DEFF Research Database (Denmark)

    Hansdotter Andersson, Pernilla; Wille-Jørgensen, Peer; Horváth-Puhó, Erzsébet

    2016-01-01

    population. To be eligible, patients had to be 75 years or younger and curatively resected for stage II or III colorectal cancer. Exclusion criteria were hereditary colorectal cancer, no signed consent, other malignancy, and life expectancy less than 2 years due to concomitant disease. In four of the 24......INTRODUCTION: The COLOFOL trial, a prospective randomized multicenter trial comparing two follow-up regimes after curative surgical treatment for colorectal cancer, focuses on detection of asymptomatic recurrences. This paper aims to describe the design and recruitment procedure in the COLOFOL...... participating centers, we scrutinized hospital inpatient data to identify all colorectal cancer patients who underwent surgery, in order to ascertain all eligible patients who were not included in the study and to compare them with enrolled patients. RESULTS: Of a total of 4,445 eligible patients, 2...

  7. Ethics of clinical trials.

    Science.gov (United States)

    Palter, S F

    1996-05-01

    The modern clinical trial is a form of human experimentation. There is a long history of disregard for individual rights of the patient in this context, and special attention must be paid to ethical guidelines for these studies. Clinical trials differ in basic ways from clinical practice. Foremost is the introduction of outside interests, beyond those of the patient's health, into the doctor-patient therapeutic alliance. Steps must be taken to protect the interests of the patient when such outside influence exists. Kantian moral theory and the Hippocratic oath dictate that the physician must respect the individual patient's rights and hold such interests paramount. These principles are the basis for informed consent. Randomization of patients is justified when a condition of equipoise exists. The changing nature of health care delivery in the United States introduces new outside interests into the doctor-patient relationship.

  8. Gateways to clinical trials.

    Science.gov (United States)

    Bayés, M; Rabasseda, X; Prous, J R

    2007-12-01

    Gateways to Clinical Trials are a guide to the most recent clinical trials in current literature and congresses. The data in the following tables has been retrieved from the Clinical Trials Knowledge Area of Prous Science Intergrity, the drug discovery and development portal, http://integrity.prous.com. This issue focuses on the following selection of drugs: 249553, 2-Methoxyestradiol; Abatacept, Adalimumab, Adefovir dipivoxil, Agalsidase beta, Albinterferon alfa-2b, Aliskiren fumarate, Alovudine, Amdoxovir, Amlodipine besylate/atorvastatin calcium, Amrubicin hydrochloride, Anakinra, AQ-13, Aripiprazole, AS-1404, Asoprisnil, Atacicept, Atrasentan; Belimumab, Bevacizumab, Bortezomib, Bosentan, Botulinum toxin type B, Brivaracetam; Catumaxomab, Cediranib, Cetuximab, cG250, Ciclesonide, Cinacalcet hydrochloride, Curcumin, Cypher; Darbepoetin alfa, Denosumab, Dihydrexidine; Eicosapentaenoic acid/docosahexaenoic acid, Entecavir, Erlotinib hydrochloride, Escitalopram oxalate, Etoricoxib, Everolimus, Ezetimibe; Febuxostat, Fenspiride hydrochloride, Fondaparinux sodium; Gefitinib, Ghrelin (human), GSK-1562902A; HSV-tk/GCV; Iclaprim, Imatinib mesylate, Imexon, Indacaterol, Insulinotropin, ISIS-112989; L-Alanosine, Lapatinib ditosylate, Laropiprant; Methoxy polyethylene glycol-epoetin-beta, Mipomersen sodium, Motexafin gadolinium; Natalizumab, Nimotuzumab; OSC, Ozarelix; PACAP-38, Paclitaxel nanoparticles, Parathyroid Hormone-Related Protein-(1-36), Pasireotide, Pegfilgrastim, Peginterferon alfa-2a, Peginterferon alfa-2b, Pemetrexed disodium, Pertuzumab, Picoplatin, Pimecrolimus, Pitavastatin calcium, Plitidepsin; Ranelic acid distrontium salt, Ranolazine, Recombinant human relaxin H2, Regadenoson, RFB4(dsFv)-PE38, RO-3300074, Rosuvastatin calcium; SIR-Spheres, Solifenacin succinate, Sorafenib, Sunitinib malate; Tadalafil, Talabostat, Taribavirin hydrochloride, Taxus, Temsirolimus, Teriparatide, Tiotropium bromide, Tipifarnib, Tirapazamine, Tocilizumab; UCN-01, Ularitide

  9. Gateways to clinical trials.

    Science.gov (United States)

    Bayés, M; Rabasseda, X; Prous, J R

    2005-04-01

    Gateways to Clinical Trials is a guide to the most recent clinical trials in current literature and congresses. The data in the following tables has been retrieved from the Clinical Trials Knowledge Area of Prous Science Integrity, the drug discovery and development portal, http://integrity. prous.com. This issue focuses on the following selection of drugs: ABX-IL-8, Acclaim, adalimumab, AGI-1067, alagebrium chloride, alemtuzumab, Alequel, Androgel, anti-IL-12 MAb, AOD-9604, aripiprazole, atomoxetine hydrochloride; Biphasic insulin aspart, bosentan, botulinum toxin type B, bovine lactoferrin, brivudine; Cantuzumab mertansine, CB-1954, CDB-4124, CEA-TRICOM, choriogonadotropin alfa, cilansetron, CpG-10101, CpG-7909, CTL-102, CTL-102/CB-1954; DAC:GRF, darbepoetin alfa, davanat-1, decitabine, del-1 Genemedicine, dexanabinol, dextofisopam, dnaJP1, dronedarone hydrochloride, dutasteride; Ecogramostim, eletriptan, emtricitabine, EPI-hNE-4, eplerenone, eplivanserin fumarate, erlotinib hydrochloride, ertapenem sodium, escitalopram oxalate, esomeprazole magnesium, etoricoxib, ezetimibe; Falecalcitriol, fingolimod hydrochloride; Gepirone hydrochloride; HBV-ISS, HSV-2 theracine, human insulin; Imatinib mesylate, Indiplon, insulin glargine, ISAtx-247; L612 HuMAb, levodopa/carbidopa/entacapone, lidocaine/prilocaine, LL-2113AD, lucinactant, LY-156735; Meclinertant, metelimumab, morphine hydrochloride, morphine-6-glucuronide; Natalizumab, nimotuzumab, NX-1207, NYVAC-HIV C; Omalizumab, onercept, osanetant; PABA, palosuran sulfate, parathyroid hormone (human recombinant), parecoxib sodium, PBI-1402, PCK-3145, peginterferon alfa-2a, peginterferon alfa-2b, peginterferon alfa-2b/ribavirin, pemetrexed disodium, pimecrolimus, PINC, pregabalin; Ramelteon, rasagiline mesilate, rasburicase, rimonabant hydrochloride, RO-0098557, rofecoxib, rosiglitazone maleate/metformin hydrochloride; Safinamide mesilate, SHL-749, sitaxsentan sodium, sparfosic acid, SprayGel, squalamine, St. John's Wort

  10. Clinical trials in India.

    Science.gov (United States)

    Maiti, Rituparna; M, Raghavendra

    2007-07-01

    The concept of outsourcing for the development and global studies on new drugs has become widely accepted in the pharmaceutical industry due to its cost and uncertainty. India is going to be the most preferred location for contract pharma research and development due to its huge treatment naïve population, human resources, technical skills, adoption/amendment/implementation of rules/laws by regulatory authorities, and changing economic environment. But still 'miles to go' to fulfill the pre-requisites to ensure India's success. In spite of all the pitfalls, the country is ambitious and optimist to attract multinational pharmaceutical companies to conduct their clinical trials in India.

  11. Clinical trials in dentistry in India: Analysis from trial registry.

    Science.gov (United States)

    Gowri, S; Kannan, Sridharan

    2017-01-01

    Evidence-based practice requires clinical trials to be performed. In India, if any clinical trial has to be performed, it has to be registered with clinical trial registry of India. Studies have shown that the report of clinical trials is poor in dentistry. Hence, the present study has been conducted to assess the type and trends of clinical trials being undertaken in dentistry in India over a span of 6 years. All the clinical trials which were registered with the Central Trial Registry of India (CTRI) (www.ctri.nic.in) from January 1, 2007 to March 3, 2014 were evaluated using the keyword "dental." Following information were collected for each of the clinical trials obtained from the search; number of centres (single center/multicentric), type of the institution undertaking the research (government/private/combined), study (observational/interventional), study design (randomized/single blinded/double-blinded), type of health condition, type of participants (healthy/patients), sponsors (academia/commercial), phase of clinical trial (Phase 1/2/3/4), publication details (published/not published), whether it was a postgraduate thesis or not and prospective or retrospective registration of clinical trials, methodological quality (method of randomization, allocation concealment). Descriptive statistics was used for analysis of various categories. Trend analysis was done to assess the changes over a period of time. The search yielded a total of 84 trials of which majority of them were single centered. Considering the study design more than half of the registered clinical trials were double-blinded (47/84 [56%]). With regard to the place of conducting a trial, most of the trials were planned to be performed in private hospitals (56/84 [66.7%]). Most (79/84, 94.1%) of the clinical trials were interventional while only 5/84 (5.9%) were observational. Majority (65/84, 77.4%) of the registered clinical trials were recruiting patients while the rest were being done in healthy

  12. Japan nuclear ship sea trial

    International Nuclear Information System (INIS)

    Yamazaki, Hiroshi; Kitamura, Toshikatus; Mizushima, Toshihiko

    1992-01-01

    The sea trial of the first Japan nuclear Ship 'MUTSU' was conducted from the end of October to December in 1990. The purpose of the sea trial was to verify the nuclear propulsive performances and maneuverabilities. The present report describes the results of the sea trial. These results are classified into four items: 1. Speed test and engineering performance tests 2. Maneuvering performance tests 3. Vibration tests 4. Other tests. Acceptable performances were demonstrated, as expected in the original design. The experience of the use of the Global Positioning System (GPS), which were newly adopted for the sea trial, is also reported. (author)

  13. [Maraviroc: clinical trials results].

    Science.gov (United States)

    Chidiac, C; Katlama, C; Yeni, P

    2008-03-01

    Just over a decade after identification of chemokine receptors CCR5 and CXCR4 as coreceptors for HIV, maraviroc (Celsentri), the first CCR5 antagonist, has recently obtained its Marketing Authorization in the United States and Europe, for treatment of treatment-experienced adult patients infected with only CCR5-tropic HIV-1 detectable. CCR5 antagonists, after fusion inhibitor enfuvirtide available since 2003, also belong to entry inhibitors. These molecules, unlike previous antiretrovirals, do not target the virus but its target cell by blocking viral penetration. Maraviroc has shown its clinical efficacy in patients failing other antiretroviral classes. Its safety profile was similar to placebo in two large phase III trials. However, careful assessment of both hepatic and immunologic safety of this new therapeutic class is needed. Viral tropism testing has to be investigated before using maraviroc in the clinic, because CCR5 antagonists are not active against CXCR4 viruses. For the moment indicated for the treatment-experienced patient population, maraviroc could in the future benefit to other types of patients, depending on ongoing trials results.

  14. Gateways to clinical trials.

    Science.gov (United States)

    Bayés, M; Rabasseda, X; Prous, J R

    2006-10-01

    Gateways to Clinical Trials are a guide to the most recent clinical trials in current literature and congresses. The data the following tables have been retrieved from the Clinical Trials Knowledge Area of Prous Science Integrity, the drug discovery and development portal, http://integrity.prous.com. This issues focuses on the following selection of drugs: (-)-Epigallocatechin gallate, (-)-gossypol, 2-deoxyglucose, 3,4-DAP, 7-monohydroxyethylrutoside; Ad5CMV-p53, adalimumab, adefovir dipivoxil, ADH-1, alemtuzumab, aliskiren fumarate, alvocidib hydrochloride, aminolevulinic acid hydrochloride, aminolevulinic acid methyl ester, amrubicin hydrochloride, AN-152, anakinra, anecortave acetate, antiasthma herbal medicine intervention, AP-12009, AP-23573, apaziquone, aprinocarsen sodium, AR-C126532, AR-H065522, aripiprazole, armodafinil, arzoxifene hydrochloride, atazanavir sulfate, atilmotin, atomoxetine hydrochloride, atorvastatin, avanafil, azimilide hydrochloride; Bevacizumab, biphasic insulin aspart, BMS-214662, BN-83495, bortezomib, bosentan, botulinum toxin type B; Caspofungin acetate, cetuximab, chrysin, ciclesonide, clevudine, clofarabine, clopidogrel, CNF-1010, CNTO-328, CP-751871, CX-717, Cypher; Dapoxetine hydrochloride, darifenacin hydrobromide, dasatinib, deferasirox, dextofisopam, dextromethorphan/quinidine sulfate, diclofenac, dronedarone hydrochloride, drotrecogin alfa (activated), duloxetine hydrochloride, dutasteride; Edaravone, efaproxiral sodium, emtricitabine, entecavir, eplerenone, epratuzumab, erlotinib hydrochloride, escitalopram oxalate, etoricoxib, ezetimibe, ezetimibe/simvastatin; Finrozole, fipamezole hydrochloride, fondaparinux sodium, fulvestrant; Gabapentin enacarbil, gaboxadol, gefitinib, gestodene, ghrelin (human); Human insulin, human papillomavirus vaccine; Imatinib mesylate, immunoglobulin intravenous (human), indiplon, insulin detemir, insulin glargine, insulin glulisine, intranasal insulin, istradefylline, i.v. gamma

  15. Market trials of irradiated chicken

    International Nuclear Information System (INIS)

    Fox, John A.; Olson, Dennis G.

    1998-01-01

    The potential market for irradiated chicken breasts was investigated using a mail survey and a retail trial. Results from the mail survey suggested a significantly higher level of acceptability of irradiated chicken than did the retail trial. A subsequent market experiment involving actual purchases showed levels of acceptability similar to that of the mail survey when similar information about food irradiation was provided

  16. Cross-Over Clinical Trials?

    Directory of Open Access Journals (Sweden)

    Latif Gachkar

    2017-01-01

    Full Text Available Abstract Cross-Over Clinical Trials in comparison with Parallel groups clinical trials have some advantages such as control of confounding variables, small sample size, and short time to implement the research project. But this type of research has few essential limitations that discusses in this monogram.

  17. OARSI Clinical Trials Recommendations

    DEFF Research Database (Denmark)

    Emery, C. A.; Roos, Ewa M.; Verhagen, E.

    2015-01-01

    The risk of post-traumatic osteoarthritis (PTOA) substantially increases following joint injury. Research efforts should focus on investigating the efficacy of preventative strategies in high quality randomized controlled trials (RCT). The objective of these OARSI RCT recommendations is to inform...... the design, conduct and analytical approaches to RCTs evaluating the preventative effect of joint injury prevention strategies. Recommendations regarding the design, conduct, and reporting of RCTs evaluating injury prevention interventions were established based on the consensus of nine researchers...... internationally with expertise in epidemiology, injury prevention and/or osteoarthritis (OA). Input and resultant consensus was established through teleconference, face to face and email correspondence over a 1 year period. Recommendations for injury prevention RCTs include context specific considerations...

  18. Industrial demonstration trials

    International Nuclear Information System (INIS)

    Gelee, M.; Fabre, C.; Villepoix, R. de; Fra, J.; Le Foulgoc, L.; Morel, Y.; Querite, P.; Roques, R.

    1975-01-01

    Prototypes of the plant components, meeting the specifications set by the process and built by industrial firms in collaboration with the supervisor and the C.E.A., are subjected to trial runs on the UF 6 test bench of the Pierrelatte testing zone. These items of equipment (diffuser, compressor, exchanger) are placed in an industrial operation context very similar to that of an enrichment plant. Their performance is measured within a broad region around the working point and their reliability observed over periods up to several tens of thousands of hours. Between 1969 and 1973 six industrial demonstration test benches have been built, marking the stages in the technical preparation of the 1973 file on the basis of which the decision of building was taken by Eurodif [fr

  19. LTDNA Evidence on Trial

    Science.gov (United States)

    Roberts, Paul

    2016-01-01

    Adopting the interpretative/hermeneutical method typical of much legal scholarship, this article considers two sets of issues pertaining to LTDNA profiles as evidence in criminal proceedings. The section titled Expert Evidence as Forensic Epistemic Warrant addresses some rather large questions about the epistemic status and probative value of expert testimony in general. It sketches a theoretical model of expert evidence, highlighting five essential criteria: (1) expert competence; (2) disciplinary domain; (3) methodological validity; (4) materiality; and (5) legal admissibility. This generic model of expert authority, highlighting law's fundamentally normative character, applies to all modern forms of criminal adjudication, across Europe and farther afield. The section titled LTDNA Evidence in UK Criminal Trials then examines English and Northern Irish courts' attempts to get to grips with LTDNA evidence in recent cases. Better appreciating the ways in which UK courts have addressed the challenges of LTDNA evidence may offer some insights into parallel developments in other legal systems. Appellate court rulings follow a predictable judicial logic, which might usefully be studied and reflected upon by any forensic scientist or statistician seeking to operate effectively in criminal proceedings. Whilst each legal jurisdiction has its own unique blend of jurisprudence, institutions, cultures and historical traditions, there is considerable scope for comparative analysis and cross-jurisdictional borrowing and instruction. In the spirit of promoting more nuanced and sophisticated international interdisciplinary dialogue, this article examines UK judicial approaches to LTDNA evidence and begins to elucidate their underlying institutional logic. Legal argument and broader policy debates are not confined to considerations of scientific validity, contamination risks and evidential integrity, or associated judgments of legal admissibility or exclusion. They also crucially

  20. ANFO truck burn trials

    Energy Technology Data Exchange (ETDEWEB)

    Rosen von, B.; Contestabile, E. [Natural Resources Canada, CANMET Canadian Explosives Research Laboratory, Ottawa, ON (Canada)

    2003-10-01

    This report describes the investigation of a tractor-trailer explosion. A truck loaded with 18,000 kg of commercial explosives, of which 13,000 kg was ammonium nitrate with fuel oil (ANFO), caught fire when it struck a rockcut near Walden, Ontario on August 5, 1998. The fire resulted in the detonation of the load. The Canadian Explosives Research Laboratory (CERL) conducted a test program to examine the suitability of existing explosive transportation regulations. Unconfined burns of ANFO were performed. The accident was recreated in two burn trials in an attempt to identify the mechanism that led from fire to detonation. Two full-scale tests were conducted using complete tractor-trailers, each in a jack-knifed position with most of the explosives placed on the ground in front of the trailer. ANFO was used in the first test to determine its response to thermal stimulus and the likelihood of detonation or explosion. The second test involved ANFO, a slurry and an emulsion. Thermocouples and video cameras were used to observe the burning characteristics of the explosives, the truck and its components. The explosives burned steadily for 80 minutes in each test. Many truck components, such as tires, spring brake chambers and the fuel tank ruptured violently due to the heat. Although no detonation occurred in the test trials, it was concluded that under favourable conditions, many truck components, might produce fragments with enough energy to initiate heat-sensitized explosives. It was suggested that a fragment impact caused the detonation at Walden. 4 refs., 7 tabs., 8 figs.

  1. LTDNA Evidence on Trial.

    Science.gov (United States)

    Roberts, Paul

    2016-01-01

    Adopting the interpretative/hermeneutical method typical of much legal scholarship, this article considers two sets of issues pertaining to LTDNA profiles as evidence in criminal proceedings. The section titled Expert Evidence as Forensic Epistemic Warrant addresses some rather large questions about the epistemic status and probative value of expert testimony in general. It sketches a theoretical model of expert evidence, highlighting five essential criteria: (1) expert competence; (2) disciplinary domain; (3) methodological validity; (4) materiality; and (5) legal admissibility. This generic model of expert authority, highlighting law's fundamentally normative character, applies to all modern forms of criminal adjudication, across Europe and farther afield. The section titled LTDNA Evidence in UK Criminal Trials then examines English and Northern Irish courts' attempts to get to grips with LTDNA evidence in recent cases. Better appreciating the ways in which UK courts have addressed the challenges of LTDNA evidence may offer some insights into parallel developments in other legal systems. Appellate court rulings follow a predictable judicial logic, which might usefully be studied and reflected upon by any forensic scientist or statistician seeking to operate effectively in criminal proceedings. Whilst each legal jurisdiction has its own unique blend of jurisprudence, institutions, cultures and historical traditions, there is considerable scope for comparative analysis and cross-jurisdictional borrowing and instruction. In the spirit of promoting more nuanced and sophisticated international interdisciplinary dialogue, this article examines UK judicial approaches to LTDNA evidence and begins to elucidate their underlying institutional logic. Legal argument and broader policy debates are not confined to considerations of scientific validity, contamination risks and evidential integrity, or associated judgments of legal admissibility or exclusion. They also crucially

  2. Do Members of the Public Have a ‘Right to Know’ about Similar Fact Evidence? The Emily Perry Story and the ‘Right to Know’ in the Context of a Fair Re-Trial

    Directory of Open Access Journals (Sweden)

    Rachel M.A. Spencer

    2014-10-01

    Full Text Available In South Australia in 1981, an intriguing criminal trial took shape around Emily Perry who was charged with two counts of attempting to murder her husband with arsenic. Similar fact evidence about the deaths of a former husband, a de facto partner and a brother led to a jury finding her guilty of the attempted murder of her husband who denied any claim that she had tried to harm him. An appeal to the South Australian Court of Criminal Appeal on the basis that the previous deaths should not have been brought to the attention of the jury was unsuccessful but Emily Perry’s case went all the way to the High Court of Australia. Her conviction was quashed and she was never re-tried. This article examines the dichotomy of an accused’s right to a fair trial (and the rules of evidence that flow from that right and the public’s so-called ‘right to know’ about a person charged with a serious offence. It posits the Perry case as an example of the opposing perspectives of lawyers and journalists, and explores the different narratives to which the case gave rise. The paper questions whether a fair re-trial for Emily Perry would ever have been possible after the vast media attention that it received. En 1981 en Australia Meridional se desarrolló un fascinante juicio criminal alrededor de Emily Perry, a quien se acusó de dos intentos de asesinar a su marido con arsénico. Pruebas similares sobre las muertes de un esposo anterior, su pareja de hecho y su hermano llevaron al jurado a declararla culpable de intento de asesinato de su marido, quien rechazó en sus declaraciones que ella hubiera tratado de hacerle daño. No prosperó una apelación a la Corte de Apelación Penal de Australia Meridional alegando que las muertes previas no deberían haberse mencionado al jurado, pero el caso de Emily Perry siguió su curso hasta el Tribunal Superior de Justicia de Australia. Se anuló su condena y nunca se le volvió a juzgar. Este artículo analiza la

  3. Using simulation to aid trial design: Ring-vaccination trials.

    Directory of Open Access Journals (Sweden)

    Matt David Thomas Hitchings

    2017-03-01

    Full Text Available The 2014-6 West African Ebola epidemic highlights the need for rigorous, rapid clinical trial methods for vaccines. A challenge for trial design is making sample size calculations based on incidence within the trial, total vaccine effect, and intracluster correlation, when these parameters are uncertain in the presence of indirect effects of vaccination.We present a stochastic, compartmental model for a ring vaccination trial. After identification of an index case, a ring of contacts is recruited and either vaccinated immediately or after 21 days. The primary outcome of the trial is total vaccine effect, counting cases only from a pre-specified window in which the immediate arm is assumed to be fully protected and the delayed arm is not protected. Simulation results are used to calculate necessary sample size and estimated vaccine effect. Under baseline assumptions about vaccine properties, monthly incidence in unvaccinated rings and trial design, a standard sample-size calculation neglecting dynamic effects estimated that 7,100 participants would be needed to achieve 80% power to detect a difference in attack rate between arms, while incorporating dynamic considerations in the model increased the estimate to 8,900. This approach replaces assumptions about parameters at the ring level with assumptions about disease dynamics and vaccine characteristics at the individual level, so within this framework we were able to describe the sensitivity of the trial power and estimated effect to various parameters. We found that both of these quantities are sensitive to properties of the vaccine, to setting-specific parameters over which investigators have little control, and to parameters that are determined by the study design.Incorporating simulation into the trial design process can improve robustness of sample size calculations. For this specific trial design, vaccine effectiveness depends on properties of the ring vaccination design and on the

  4. Social media in clinical trials.

    Science.gov (United States)

    Thompson, Michael A

    2014-01-01

    Social media has potential in clinical trials for pointing out trial issues, addressing barriers, educating, and engaging multiple groups involved in cancer clinical research. Social media is being used in clinical trials to highlight issues such as poor accrual and barriers; educate potential participants and physicians about clinical trial options; and is a potential indirect or direct method to improve accrual. We are moving from a passive "push" of information to patients to a "pull" of patients requesting information. Patients and advocates are often driving an otherwise reluctant health care system into communication. Online patient communities are creating new information repositories. Potential clinical trial participants are using the Twittersphere and other sources to learn about potential clinical trial options. We are seeing more organized patient-centric and patient-engaged forums with the potential to crowd source to improve clinical trial accrual and design. This is an evolving process that will meet many individual, institutional, and regulatory obstacles as we move forward in a changed research landscape.

  5. Quality Assurance for Clinical Trials

    Science.gov (United States)

    Ibbott, Geoffrey S.; Haworth, Annette; Followill, David S.

    2013-01-01

    Cooperative groups, of which the Radiation Therapy Oncology Group is one example, conduct national clinical trials that often involve the use of radiation therapy. In preparation for such a trial, the cooperative group prepares a protocol to define the goals of the trial, the rationale for its design, and the details of the treatment procedure to be followed. The Radiological Physics Center (RPC) is one of several quality assurance (QA) offices that is charged with assuring that participating institutions deliver doses that are clinically consistent and comparable. The RPC does this by conducting a variety of independent audits and credentialing processes. The RPC has compiled data showing that credentialing can help institutions comply with the requirements of a cooperative group clinical protocol. Phantom irradiations have been demonstrated to exercise an institution’s procedures for planning and delivering advanced external beam techniques (1–3). Similarly, RPC data indicate that a rapid review of patient treatment records or planning procedures can improve compliance with clinical trials (4). The experiences of the RPC are presented as examples of the contributions that a national clinical trials QA center can make to cooperative group trials. These experiences illustrate the critical need for comprehensive QA to assure that clinical trials are successful and cost-effective. The RPC is supported by grants CA 10953 and CA 81647 from the National Cancer Institute, NIH, DHHS. PMID:24392352

  6. Frailty Intervention Trial (FIT

    Directory of Open Access Journals (Sweden)

    Lockwood Keri

    2008-10-01

    Full Text Available Abstract Background Frailty is a term commonly used to describe the condition of an older person who has chronic health problems, has lost functional abilities and is likely to deteriorate further. However, despite its common use, only a small number of studies have attempted to define the syndrome of frailty and measure its prevalence. The criteria Fried and colleagues used to define the frailty syndrome will be used in this study (i.e. weight loss, fatigue, decreased grip strength, slow gait speed, and low physical activity. Previous studies have shown that clinical outcomes for frail older people can be improved using multi-factorial interventions such as comprehensive geriatric assessment, and single interventions such as exercise programs or nutritional supplementation, but no interventions have been developed to specifically reverse the syndrome of frailty. We have developed a multidisciplinary intervention that specifically targets frailty as defined by Fried et al. We aim to establish the effects of this intervention on frailty, mobility, hospitalisation and institutionalisation in frail older people. Methods and Design A single centre randomised controlled trial comparing a multidisciplinary intervention with usual care. The intervention will target identified characteristics of frailty, functional limitations, nutritional status, falls risk, psychological issues and management of chronic health conditions. Two hundred and thirty people aged 70 and over who meet the Fried definition of frailty will be recruited from clients of the aged care service of a metropolitan hospital. Participants will be followed for a 12-month period. Discussion This research is an important step in the examination of specifically targeted frailty interventions. This project will assess whether an intervention specifically targeting frailty can be implemented, and whether it is effective when compared to usual care. If successful, the study will establish a

  7. clinical trials of Sutherlandia frutescens

    African Journals Online (AJOL)

    economic and political imperatives surrounding randomised controlled trials and the ambiguous, or even ..... the medicinal properties of the plant, as reported both in the book, and also in the .... London, UK: Harvard University Press. Latour, B.

  8. Lung Cancer Precision Medicine Trials

    Science.gov (United States)

    Patients with lung cancer are benefiting from the boom in targeted and immune-based therapies. With a series of precision medicine trials, NCI is keeping pace with the rapidly changing treatment landscape for lung cancer.

  9. From the shadows into the light: How pretrial publicity and deliberation affect mock jurors' decisions, impressions, and memory.

    Science.gov (United States)

    Ruva, Christine L; Guenther, Christina C

    2015-06-01

    This 2-part study explored how exposure to negative pretrial publicity (Neg-PTP) influences the jury process, as well as possible mechanisms responsible for its biasing effects on decisions. Study Part A explored how PTP and jury deliberations affect juror/jury verdicts, memory, and impressions of the defendant and attorneys. One week before viewing a criminal trial mock-jurors (N = 320 university students) were exposed to Neg-PTP or unrelated crime stories (No-PTP). Two days later deliberating jurors came to a group decision, whereas nondeliberating jurors completed an unrelated task before making an individual decision. Neg-PTP jurors were more likely to vote guilty, make memory errors, and rate the defendant lower in credibility. Deliberation reduced Neg-PTP jurors' memory accuracy and No-PTP jurors' guilty verdicts (leniency bias). Jurors' memory and ratings of the defendant and prosecuting attorney significantly mediated the effect of PTP on guilt ratings. Study Part B content analyzed 30 mock-jury deliberations and explored how PTP influenced deliberations and ultimately jury decisions. Neg-PTP juries were more likely than No-PTP juries to discuss ambiguous trial evidence in a proprosecution manner and less likely to discuss judicial instructions and lack of evidence. All Neg-PTP juries mentioned PTP, after instructed otherwise, and rarely corrected jury members who mentioned PTP. Discussion of ambiguous trial evidence in a proprosecution manner and lack of evidence significantly mediated the effect of PTP on jury-level guilt ratings. Together the findings suggest that judicial admonishments and deliberations may not be sufficient to reduce PTP bias, because of memory errors, biased impressions, and predecisional distortion. (c) 2015 APA, all rights reserved).

  10. a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    MS Yıldırım

    2016-02-01

    Full Text Available The aim of this study was to compare the effects of static stretching, proprioceptive neuromuscular facilitation (PNF stretching and Mulligan technique on hip flexion range of motion (ROM in subjects with bilateral hamstring tightness. A total of 40 students (mean age: 21.5±1.3 years, mean body height: 172.8±8.2 cm, mean body mass index: 21.9±3.0 kg • m-2 with bilateral hamstring tightness were enrolled in this randomized trial, of whom 26 completed the study. Subjects were divided into 4 groups performing (I typical static stretching, (II PNF stretching, (III Mulligan traction straight leg raise (TSLR technique, (IV no intervention. Hip flexion ROM was measured using a digital goniometer with the passive straight leg raise test before and after 4 weeks by two physiotherapists blinded to the groups. 52 extremities of 26 subjects were analyzed. Hip flexion ROM increased in all three intervention groups (p<0.05 but not in the no-intervention group after 4 weeks. A statistically significant change in initial–final assessment differences of hip flexion ROM was found between groups (p<0.001 in favour of PNF stretching and Mulligan TSLR technique in comparison to typical static stretching (p=0.016 and p=0.02, respectively. No significant difference was found between Mulligan TSLR technique and PNF stretching (p=0.920. The initial–final assessment difference of hip flexion ROM was similar in typical static stretching and no intervention (p=0.491. A 4-week stretching intervention is beneficial for increasing hip flexion ROM in bilateral hamstring tightness. However, PNF stretching and Mulligan TSLR technique are superior to typical static stretching. These two interventions can be alternatively used for stretching in hamstring tightness.

  11. Global warming on trial

    International Nuclear Information System (INIS)

    Broeker, W.S.

    1992-01-01

    Jim Hansen, a climatologist at NASA's Goddard Space Institute, is convinced that the earth's temperature is rising and places the blame on the buildup of greenhouse gases in the atmosphere. Unconvinced, John Sununu, former White House chief of staff, doubts that the warming will be great enough to produce serious threat and fears that measures to reduce the emissions would throw a wrench into the gears that drive the Unites States' troubled economy. During his three years at the White House, Sununu's view prevailed, and although his role in the debate has diminished, others continue to cast doubt on the reality of global warming. A new lobbying group called the Climate Council has been created to do just this. Burning fossil fuels is not the only problem; a fifth of emissions of carbon dioxide now come from clearing and burning forests. Scientists are also tracking a host of other greenhouse gases that emanate from a variety of human activities; the warming effect of methane, chlorofluorocarbons and nitrous oxide combined equals that of carbon dioxide. Although the current warming from these gases may be difficult to detect against the background noise of natural climate variation, most climatologists are certain that as the gases continue to accumulate, increases in the earth's temperature will become evident even to skeptics. If the reality of global warming were put on trial, each side would have trouble making its case. Jim Hansen's side could not prove beyond a reasonable doubt that carbon dioxide and other greenhouse gases have warmed the planet. But neither could John Sununu's side prove beyond a reasonable doubt that the warming expected from greenhouse gases has not occurred. To see why each side would have difficulty proving its case, this article reviews the arguments that might be presented in such a hearing

  12. Trial Watch: Anticancer radioimmunotherapy.

    Science.gov (United States)

    Vacchelli, Erika; Vitale, Ilio; Tartour, Eric; Eggermont, Alexander; Sautès-Fridman, Catherine; Galon, Jérôme; Zitvogel, Laurence; Kroemer, Guido; Galluzzi, Lorenzo

    2013-09-01

    Radiotherapy has extensively been employed as a curative or palliative intervention against cancer throughout the last century, with a varying degree of success. For a long time, the antineoplastic activity of X- and γ-rays was entirely ascribed to their capacity of damaging macromolecules, in particular DNA, and hence triggering the (apoptotic) demise of malignant cells. However, accumulating evidence indicates that (at least part of) the clinical potential of radiotherapy stems from cancer cell-extrinsic mechanisms, including the normalization of tumor vasculature as well as short- and long-range bystander effects. Local bystander effects involve either the direct transmission of lethal signals between cells connected by gap junctions or the production of diffusible cytotoxic mediators, including reactive oxygen species, nitric oxide and cytokines. Conversely, long-range bystander effects, also known as out-of-field or abscopal effects, presumably reflect the elicitation of tumor-specific adaptive immune responses. Ionizing rays have indeed been shown to promote the immunogenic demise of malignant cells, a process that relies on the spatiotemporally defined emanation of specific damage-associated molecular patterns (DAMPs). Thus, irradiation reportedly improves the clinical efficacy of other treatment modalities such as surgery (both in neo-adjuvant and adjuvant settings) or chemotherapy. Moreover, at least under some circumstances, radiotherapy may potentiate anticancer immune responses as elicited by various immunotherapeutic agents, including (but presumably not limited to) immunomodulatory monoclonal antibodies, cancer-specific vaccines, dendritic cell-based interventions and Toll-like receptor agonists. Here, we review the rationale of using radiotherapy, alone or combined with immunomodulatory agents, as a means to elicit or boost anticancer immune responses, and present recent clinical trials investigating the therapeutic potential of this approach in

  13. LTDNA Evidence on Trial

    Directory of Open Access Journals (Sweden)

    Paul Roberts

    2016-10-01

    factfinders in criminal trials.

  14. Successful recruitment to trials: findings from the SCIMITAR+ Trial.

    Science.gov (United States)

    Peckham, Emily; Arundel, Catherine; Bailey, Della; Callen, Tracy; Cusack, Christina; Crosland, Suzanne; Foster, Penny; Herlihy, Hannah; Hope, James; Ker, Suzy; McCloud, Tayla; Romain-Hooper, Crystal-Bella; Stribling, Alison; Phiri, Peter; Tait, Ellen; Gilbody, Simon

    2018-01-19

    Randomised controlled trials (RCT) can struggle to recruit to target on time. This is especially the case with hard to reach populations such as those with severe mental ill health. The SCIMITAR+ trial, a trial of a bespoke smoking cessation intervention for people with severe mental ill health achieved their recruitment ahead of time and target. This article reports strategies that helped us to achieve this with the aim of aiding others recruiting from similar populations. SCIMITAR+ is a multi-centre pragmatic two-arm parallel-group RCT, which aimed to recruit 400 participants with severe mental ill health who smoke and would like to cut down or quit. The study recruited primarily in secondary care through community mental health teams and psychiatrists with a smaller number of participants recruited through primary care. Recruitment opened in October 2015 and closed in December 2016, by which point 526 participants had been recruited. We gathered information from recruiting sites on strategies which led to the successful recruitment in SCIMITAR+ and in this article present our approach to trial management along with the strategies employed by the recruiting sites. Alongside having a dedicated trial manager and trial management team, we identified three main themes that led to successful recruitment. These were: clinicians with a positive attitude to research; researchers and clinicians working together; and the use of NHS targets. The overriding theme was the importance of relationships between both the researchers and the recruiting clinicians and the recruiting clinicians and the participants. This study makes a significant contribution to the limited evidence base of real-world cases of successful recruitment to RCTs and offers practical guidance to those planning and conducting trials. Building positive relationships between clinicians, researchers and participants is crucial to successful recruitment.

  15. Clinical trials. A pending subject.

    Science.gov (United States)

    Gil-Extremera, B; Jiménez-López, P; Mediavilla-García, J D

    2018-04-01

    Clinical trials are essential tools for the progress of clinical medicine in its diagnostic and therapeutic aspects. Since the first trial in 1948, which related tobacco use with lung cancer, there have been more than 150,000 clinical trials to date in various areas (paediatrics, cardiology, oncology, endocrinology, etc.). This article highlights the importance for all physicians to participate, over the course of their professional career, in a clinical trial, due to the inherent benefits for patients, the progress of medicine and for curricular prestige. The authors have created a synthesis of their experience with clinical trials on hypertension, diabetes, dyslipidaemia and ischaemic heart disease over the course of almost 3 decades. Furthermore, a brief reference has been made to the characteristics of a phase I unit, as well as to a number of research studies currently underway. Copyright © 2017 Elsevier España, S.L.U. and Sociedad Española de Medicina Interna (SEMI). All rights reserved.

  16. Pragmatic trial design elements showed a different impact on trial interpretation and feasibility than explanatory elements

    NARCIS (Netherlands)

    Nieuwenhuis, Joost B.; Irving, Elaine; Oude Rengerink, Katrien; Lloyd, Emily; Goetz, Iris; Grobbee, Diederick E.; Stolk, Pieter; Groenwold, Rolf H H; Zuidgeest, Mira G P

    2016-01-01

    OBJECTIVE: To illustrate how pragmatic trial design elements, or inserting explanatory trial elements in pragmatic trials affect validity, generalizability, precision and operational feasibility. STUDY DESIGN AND SETTING: From illustrative examples identified through the IMI Get Real Consortium, we

  17. Practical trials in medical education

    DEFF Research Database (Denmark)

    Tolsgaard, Martin G; Kulasegaram, Kulamakan M; Ringsted, Charlotte

    2017-01-01

    participants across several settings and (iii) multiple outcome measures with long-term follow-up to evaluate both benefits and risks. Questions posed by practical trials may be proactive in applying theory in the development of educational innovations or reactive to educational reforms and innovations. Non......CONTEXT: Concerns have been raised over the gap between education theory and practice and how research can contribute to inform decision makers on their choices and priorities. Little is known about how educational theories and research outcomes produced under optimal conditions in highly...... controlled settings generalise to the real-life education context. One way of bridging this gap is applying the concept of practical trials in medical education. In this paper we elaborate on characteristics of practical trials and based on examples from medical education we discuss the challenges...

  18. Adaptive designs in clinical trials

    Directory of Open Access Journals (Sweden)

    Suresh Bowalekar

    2011-01-01

    Full Text Available In addition to the expensive and lengthy process of developing a new medicine, the attrition rate in clinical research was on the rise, resulting in stagnation in the development of new compounds. As a consequence to this, the US Food and Drug Administration released a critical path initiative document in 2004, highlighting the need for developing innovative trial designs. One of the innovations suggested the use of adaptive designs for clinical trials. Thus, post critical path initiative, there is a growing interest in using adaptive designs for the development of pharmaceutical products. Adaptive designs are expected to have great potential to reduce the number of patients and duration of trial and to have relatively less exposure to new drug. Adaptive designs are not new in the sense that the task of interim analysis (IA/review of the accumulated data used in adaptive designs existed in the past too. However, such reviews/analyses of accumulated data were not necessarily planned at the stage of planning clinical trial and the methods used were not necessarily compliant with clinical trial process. The Bayesian approach commonly used in adaptive designs was developed by Thomas Bayes in the 18th century, about hundred years prior to the development of modern statistical methods by the father of modern statistics, Sir Ronald A. Fisher, but the complexity involved in Bayesian approach prevented its use in real life practice. The advances in the field of computer and information technology over the last three to four decades has changed the scenario and the Bayesian techniques are being used in adaptive designs in addition to other sequential methods used in IA. This paper attempts to describe the various adaptive designs in clinical trial and views of stakeholders about feasibility of using them, without going into mathematical complexities.

  19. Adaptive designs in clinical trials.

    Science.gov (United States)

    Bowalekar, Suresh

    2011-01-01

    In addition to the expensive and lengthy process of developing a new medicine, the attrition rate in clinical research was on the rise, resulting in stagnation in the development of new compounds. As a consequence to this, the US Food and Drug Administration released a critical path initiative document in 2004, highlighting the need for developing innovative trial designs. One of the innovations suggested the use of adaptive designs for clinical trials. Thus, post critical path initiative, there is a growing interest in using adaptive designs for the development of pharmaceutical products. Adaptive designs are expected to have great potential to reduce the number of patients and duration of trial and to have relatively less exposure to new drug. Adaptive designs are not new in the sense that the task of interim analysis (IA)/review of the accumulated data used in adaptive designs existed in the past too. However, such reviews/analyses of accumulated data were not necessarily planned at the stage of planning clinical trial and the methods used were not necessarily compliant with clinical trial process. The Bayesian approach commonly used in adaptive designs was developed by Thomas Bayes in the 18th century, about hundred years prior to the development of modern statistical methods by the father of modern statistics, Sir Ronald A. Fisher, but the complexity involved in Bayesian approach prevented its use in real life practice. The advances in the field of computer and information technology over the last three to four decades has changed the scenario and the Bayesian techniques are being used in adaptive designs in addition to other sequential methods used in IA. This paper attempts to describe the various adaptive designs in clinical trial and views of stakeholders about feasibility of using them, without going into mathematical complexities.

  20. The DiaS trial

    DEFF Research Database (Denmark)

    Andreasson, Kate; Krogh, Jesper; Rosenbaum, Bent

    2014-01-01

    BACKGROUND: In Denmark 8,000 to 10,000 people will attempt suicide each year. The Centre of Excellence in Suicide Prevention in the Capital Region of Denmark is treating patients with suicidal behavior, and a recent survey has shown that 30% of the patients are suffering from borderline personali...... measured at week 28. Other exploratory outcomes are included such as severity of symptoms, suicide intention and ideation, depression, hopelessness, self-esteem, impulsivity, anger, and duration of respective treatments. TRIAL REGISTRATION: Clinical Trial.gov: NCT01512602....

  1. Problematic trial detection in ClinicalTrials.gov

    NARCIS (Netherlands)

    Hartgerink, C.H.J.; George, Stephen

    2015-01-01

    Clinical trials are crucial in determining the effectiveness of treatments and directly affect clinical and policy decisions. These decisions are undermined if the data are problematic due to data fabrication or other errors. Researchers have worked on developing statistical methods to detect

  2. Evaluation Using Sequential Trials Methods.

    Science.gov (United States)

    Cohen, Mark E.; Ralls, Stephen A.

    1986-01-01

    Although dental school faculty as well as practitioners are interested in evaluating products and procedures used in clinical practice, research design and statistical analysis can sometimes pose problems. Sequential trials methods provide an analytical structure that is both easy to use and statistically valid. (Author/MLW)

  3. SARCOPENIA: DESIGNING PHASE IIB TRIALS

    Science.gov (United States)

    CHUMLEA, WM.C.; CESARI, M.; EVANS, W.J.; FERRUCCI, L.; FIELDING, R.A.; PAHOR, M.; STUDENSKI, S.; VELLAS, B.

    2012-01-01

    Sarcopenia is the age-related involuntary loss of skeletal muscle mass and functionality that can lead to the development of disability, frailty and increased health care costs. The development of interventions aimed at preventing and/or treating sarcopenia is complex, requiring the adoption of assumptions and standards that are not well established scientifically or clinically. A number of investigators and clinicians (both from academia and industry) met in Rome (Italy) in 2009 to develop a consensus definition of sarcopenia. Subsequently, in Albuquerque (New Mexico, USA) in 2010, the same group met again to consider the complex issues necessary for designing Phase II clinical trials for sarcopenia. Current clinical trial data indicate that fat-free mass (FFM) parameters are responsive to physical activity/nutritional treatment modalities over short time periods, but pharmacological trials of sarcopenia have yet to show significant efficacy. In order to conduct a clinical trial within a reasonable time frame, groups that model or display accelerated aging and loss of FFM are necessary. Few studies have used acceptable designs for testing treatment effects, sample sizes or primary outcomes that could provide interpretable findings or effects across studies. Dual energy x ray absorptiometry (DXA) is the measure of choice for assessing FFM, but sufficient time is needed for changes to be detected accurately and reliably. A tool set that would allow clinical, basic and epidemiological research on sarcopenia to advance rapidly toward diagnosis and treatment phases should be those reflecting function and strength. PMID:21623466

  4. The Best Bypass Surgery Trial

    DEFF Research Database (Denmark)

    Møller, Christian H; Jensen, Birte Østergaard; Gluud, Christian

    2007-01-01

    Recent trials suggest that off-pump coronary artery bypass grafting (OPCAB) reduces the risk of mortality and morbidity compared with conventional coronary artery bypass grafting (CCAB) using cardiopulmonary bypass. Patients with a moderate- to high-risk of complications after CCAB may have...

  5. Medical Editors Trial Amnesty (META)

    African Journals Online (AJOL)

    may change jobs, with the result that important work remains unfinished; or investigators may discover a recently published trial on the same topic and conclude that their own results are now redundant. Editors must also take some responsibility. There is a limit to the number of reports we can publish and sometimes we are ...

  6. [Lower Uterine Segment Trial: A pragmatic open multicenter randomized trial].

    Science.gov (United States)

    Rozenberg, P; Deruelle, P; Sénat, M-V; Desbrière, R; Winer, N; Simon, E; Ville, Y; Kayem, G; Boutron, I

    2018-04-01

    The data from literature show that trial of labor and elective repeat cesarean delivery after a prior cesarean delivery both present significant risks and benefits, and these risks and benefits differ for the woman and her fetus. The benefits to the woman can be at the expense of her fetus and vice-versa. This uncertainty is compounded by the scarcity of high-level evidence that preclude accurate quantification of the risks and benefits that could help provide a fair counseling about a trial of labor and elective repeat cesarean delivery. An interesting way of research is to evaluate the potential benefits of a decision rule associated to the ultrasound measurement of the lower uterine segment (LUS). Indeed, ultrasonography may be helpful in determining a specific risk for a given patient by measuring the thickness of the LUS, i,e, the thickness of the cesarean delivery scar area. Although only small and often methodologically biased data have been published, they look promising as their results are concordant: ultrasonographic measurements of the LUS thickness is highly correlated with the intraoperative findings at cesarean delivery. Furthermore, the thinner the LUS becomes on ultrasound, the higher the likelihood of a defect in the LUS. Finally, ultrasound assessment of LUS has an excellent negative predictive value for the risk of uterine defect. Therefore, this exam associated with a rule of decision could help to reduce the rate of elective repeat cesarean delivery and especially to reduce the fetal and maternal mortality and morbidity related to trial of labor after a prior cesarean delivery. This is a pragmatic open multicenter randomized trial with two parallel arms. Randomization will be centralized and computerized. Since blindness is impossible, an adjudication committee will evaluate the components of the primary composite outcome in order to avoid evaluation bias. An interim analysis will be planned mid-strength of the trial. Ultrasound will be

  7. [Principles of controlled clinical trials].

    Science.gov (United States)

    Martini, P

    1962-01-01

    The recovery of the patient should be facilitated as the result of therapeutic research. The basic rule for every therapeutic-clinical trial mist involve a comparison of therapeutic approaches. In acute conditions, such as acute infectious diseases, infarcts, etc., comparisons should be made between two or more groups: the collective therapeutic comparison = the between patients trial. The formation of groups, to be compared one with the other can be justified only if one is reasonably sure that a pathogenic condition indeed exists. In chronic diseases, which extend essentially unchanged over a lengthy period but are nevertheless reversible, therapeutic comparisons may be made between two or more time intervals within the course of the disease in the same individual. This type of therapeutic trial rests primarily upon a (refined!) type of specious reasoning and secondarily, upon modified statistics: the individual therapeutic comparison = the within patient trial. The collective therapeutic comparison, on the one hand, and the individual therapeutic comparison on the other, overlap somewhat in scope. The immediate therapeutic effect is not always an indication of its true value, which may become evident only upon long-term treatment. The short-term trials of therapeutic regimens in an individual must, therefore, be frequently supplemented by long-term trials which can only be carried out by comparing two groups. For many clinical investigations, therefore, the joint efforts of numerous hospitals are absolutely necessary. The second basic rule of therapeutic research is the elimination of secondary causes. The difficulties introduced by these secondary considerations are far greater in therapeutic trials carried out on ambulatory patients than has been hitherto realized. In order to remove subjective secondary causes, the author demanded, in 1931, the use of hidden or illusory media (placebos, dummies) that is, unconscious causative agents. The double blind

  8. HIV/AIDS Clinical Trials Fact Sheet

    Science.gov (United States)

    ... AIDS Drugs Clinical Trials Apps skip to content HIV Overview Home Understanding HIV/AIDS Fact Sheets HIV/ ... 4 p.m. ET) Send us an email HIV/AIDS Clinical Trials Last Reviewed: August 25, 2017 ...

  9. NCI National Clinical Trials Network Structure

    Science.gov (United States)

    Learn about how the National Clinical Trials Network (NCTN) is structured. The NCTN is a program of the National Cancer Institute that gives funds and other support to cancer research organizations to conduct cancer clinical trials.

  10. Clinical trials in neurology: design, conduct, analysis

    National Research Council Canada - National Science Library

    Ravina, Bernard

    2012-01-01

    .... Clinical Trials in Neurology aims to improve the efficiency of clinical trials and the development of interventions in order to enhance the development of new treatments for neurologic diseases...

  11. PUPTH Prehospital Air Medical Plasma (PAMP) Trial

    Science.gov (United States)

    2014-07-01

    for ability to continue. If unable to improve, they may be replaced . Two formal interim analyses of efficacy will be performed when 33% and 67% of...will be entered and maintained on a password protected SSL website designed for this trial. The data entered for the PAMPer trial will be...testing procedure for clinical trials. Biometrics , 1979. 35(3): p. 549‐56. 96. Murray, D.M., ed. The Design and Analysis of Group Randomized Trials

  12. Trial-to-Trial Fluctuations in Attentional State and Their Relation to Intelligence

    Science.gov (United States)

    Unsworth, Nash; McMillan, Brittany D.

    2014-01-01

    Trial-to-trial fluctuations in attentional state while performing measures of intelligence were examined in the current study. Participants performed various measures of fluid and crystallized intelligence while also providing attentional state ratings prior to each trial. It was found that pre-trial attentional state ratings strongly predicted…

  13. Interpreting clinical trial results by deductive reasoning: In search of improved trial design.

    Science.gov (United States)

    Kurbel, Sven; Mihaljević, Slobodan

    2017-10-01

    Clinical trial results are often interpreted by inductive reasoning, in a trial design-limited manner, directed toward modifications of the current clinical practice. Deductive reasoning is an alternative in which results of relevant trials are combined in indisputable premises that lead to a conclusion easily testable in future trials. © 2017 WILEY Periodicals, Inc.

  14. Trial Courts in the Judicial Process.

    Science.gov (United States)

    McKnight, R. Neal

    1981-01-01

    Describes a college course which examines the organizational and behavioral characteristics of trial courts in the American judicial process. A major course objective is to help students understand the trial court process as a political process by showing how trial court organizations are involved in the allocation of social values. (RM)

  15. Terrorists on Trial: A Performative Perspective

    NARCIS (Netherlands)

    de Graaf, B.A.

    On 30 March 2011, ICCT – The Hague organised an Expert Meeting entitled ‘Terrorism Trials as Theatre: A Performative Perspective’. The Expert Meeting applied a performative perspective to three well known and recent trials in different parts of the world: the trials against the Dutch Hofstad Group,

  16. Maximizing scientific knowledge from randomized clinical trials

    DEFF Research Database (Denmark)

    Gustafsson, Finn; Atar, Dan; Pitt, Bertram

    2010-01-01

    Trialists have an ethical and financial responsibility to plan and conduct clinical trials in a manner that will maximize the scientific knowledge gained from the trial. However, the amount of scientific information generated by randomized clinical trials in cardiovascular medicine is highly vari...

  17. Spine device clinical trials: design and sponsorship.

    Science.gov (United States)

    Cher, Daniel J; Capobianco, Robyn A

    2015-05-01

    Multicenter prospective randomized clinical trials represent the best evidence to support the safety and effectiveness of medical devices. Industry sponsorship of multicenter clinical trials is purported to lead to bias. To determine what proportion of spine device-related trials are industry-sponsored and the effect of industry sponsorship on trial design. Analysis of data from a publicly available clinical trials database. Clinical trials of spine devices registered on ClinicalTrials.gov, a publicly accessible trial database, were evaluated in terms of design, number and location of study centers, and sample size. The relationship between trial design characteristics and study sponsorship was evaluated using logistic regression and general linear models. One thousand six hundred thrity-eight studies were retrieved from ClinicalTrials.gov using the search term "spine." Of the 367 trials that focused on spine surgery, 200 (54.5%) specifically studied devices for spine surgery and 167 (45.5%) focused on other issues related to spine surgery. Compared with nondevice trials, device trials were far more likely to be sponsored by the industry (74% vs. 22.2%, odds ratio (OR) 9.9 [95% confidence interval 6.1-16.3]). Industry-sponsored device trials were more likely multicenter (80% vs. 29%, OR 9.8 [4.8-21.1]) and had approximately four times as many participating study centers (pdevices not sponsored by the industry. Most device-related spine research is industry-sponsored. Multicenter trials are more likely to be industry-sponsored. These findings suggest that previously published studies showing larger effect sizes in industry-sponsored vs. nonindustry-sponsored studies may be biased as a result of failure to take into account the marked differences in design and purpose. Copyright © 2015 Elsevier Inc. All rights reserved.

  18. Pediatric Obstructive Uropathy: Clinical Trials

    International Nuclear Information System (INIS)

    Chan, C. M. C.; Scheinman, J. I.; Roth, K. S.

    2005-01-01

    As the powerful tools of molecular biology continue to delineate new concepts of pathogenesis of diseases, new molecular-level therapeutic modalities are certain to emerge. In order to design and execute clinical trials to evaluate outcomes of these new treatment modalities, we will soon need a new supply of investigators with training and experience in clinical research. The slowly-progressive nature of chronic pediatric kidney disease often results in diagnosis being made at a time remote from initial result, and the inherently slow rate of progression makes changes difficult to measure. Thus, development of molecular markers for both diagnosis and rate of progression will be critical to studies of new therapeutic modalities. We will review general aspects of clinical trials and will use current and past studies as examples to illustrate specific points, especially as these apply to chronic kidney disease associated with obstructive uropathy in children. (author)

  19. GPON FTTH trial: lessons learned

    Science.gov (United States)

    Weis, Erik; Hölzl, Rainer; Breuer, Dirk; Lange, Christoph

    2009-11-01

    This paper reports on a FTTH field trial with GPON (Gigabit-capable passive optical network) technology in the network of Deutsche Telekom in the region of the cities of Berlin and Potsdam. Focus of this trial was to gain practical experience regarding GPON technology, fibre installation in existing ducts with micro duct technology, fibre cabling in customer buildings and impact on operational processes. Furthermore it is reported on an initial Deutsche Telekom FTTB deployment based on GPON technology in the city of Dresden with the main targets to obtain practical deployment and operation experiences with fibre-based access networks and to provide broadband access to a part of the city formerly not servable by DSL (digital subscriber line) technology.

  20. Accrual to Cancer Clinical Trials

    LENUS (Irish Health Repository)

    Kelly, C

    2016-07-01

    Accrual to cancer clinical trials (CCT) is imperative to safeguard continued improvement in cancer outcomes. A retrospective chart review was performed of patients (n=140) starting a new anti-cancer agent in a north Dublin cancer centre. This review was performed over a four-month period, beginning in November 2015. Only 29% (n=41) had a CCT option. The overall accrual rate to CCT was 5% (n=7), which is comparable to internationally reported figures. The main reasons for failure to recruit to CCT included the lack of a CCT option for cancer type (n=30, 23%), stage (n=25, 19%), and line of treatment (n=23, 17%). Over the last decade, the rate of accrual to CCTs has in fact doubled and the number of trials open to recruitment has tripled. Ongoing governmental and philanthropic support is necessary to continue this trend to further expand CCT patient options with a target accrual rate of 10%.

  1. Methodology series module 4: Clinical trials

    Directory of Open Access Journals (Sweden)

    Maninder Singh Setia

    2016-01-01

    Full Text Available In a clinical trial, study participants are (usually divided into two groups. One group is then given the intervention and the other group is not given the intervention (or may be given some existing standard of care. We compare the outcomes in these groups and assess the role of intervention. Some of the trial designs are (1 parallel study design, (2 cross-over design, (3 factorial design, and (4 withdrawal group design. The trials can also be classified according to the stage of the trial (Phase I, II, III, and IV or the nature of the trial (efficacy vs. effectiveness trials, superiority vs. equivalence trials. Randomization is one of the procedures by which we allocate different interventions to the groups. It ensures that all the included participants have a specified probability of being allocated to either of the groups in the intervention study. If participants and the investigator know about the allocation of the intervention, then it is called an "open trial." However, many of the trials are not open - they are blinded. Blinding is useful to minimize bias in clinical trials. The researcher should familiarize themselves with the CONSORT statement and the appropriate Clinical Trials Registry of India.

  2. Methodology Series Module 4: Clinical Trials.

    Science.gov (United States)

    Setia, Maninder Singh

    2016-01-01

    In a clinical trial, study participants are (usually) divided into two groups. One group is then given the intervention and the other group is not given the intervention (or may be given some existing standard of care). We compare the outcomes in these groups and assess the role of intervention. Some of the trial designs are (1) parallel study design, (2) cross-over design, (3) factorial design, and (4) withdrawal group design. The trials can also be classified according to the stage of the trial (Phase I, II, III, and IV) or the nature of the trial (efficacy vs. effectiveness trials, superiority vs. equivalence trials). Randomization is one of the procedures by which we allocate different interventions to the groups. It ensures that all the included participants have a specified probability of being allocated to either of the groups in the intervention study. If participants and the investigator know about the allocation of the intervention, then it is called an "open trial." However, many of the trials are not open - they are blinded. Blinding is useful to minimize bias in clinical trials. The researcher should familiarize themselves with the CONSORT statement and the appropriate Clinical Trials Registry of India.

  3. Credentialing for participation in clinical trials

    International Nuclear Information System (INIS)

    Followill, David S.; Urie, Marcia; Galvin, James M.; Ulin, Kenneth; Xiao, Ying; FitzGerald, Thomas J.

    2012-01-01

    The National Cancer Institute (NCI) clinical cooperative groups have been instrumental over the past 50 years in developing clinical trials and evidence-based clinical trial processes for improvements in patient care. The cooperative groups are undergoing a transformation process to launch, conduct, and publish clinical trials more rapidly. Institutional participation in clinical trials can be made more efficient and include the expansion of relationships with international partners. This paper reviews the current processes that are in use in radiation therapy trials and the importance of maintaining effective credentialing strategies to assure the quality of the outcomes of clinical trials. The paper offers strategies to streamline and harmonize credentialing tools and processes moving forward as the NCI undergoes transformative change in the conduct of clinical trials.

  4. Credentialing for participation in clinical trials

    Energy Technology Data Exchange (ETDEWEB)

    Followill, David S. [Radiological Physics Center, Department of Radiation Physics, University of Texas MD Anderson Cancer Center, Houston, TX (United States); Urie, Marcia [Quality Assurance Review Center, Department of Radiation Oncology, University of Massachusetts Medical School, Lincoln, RI (United States); Galvin, James M. [Department of Radiation Oncology, Jefferson Medical College, Thomas Jefferson University, Philadelphia, PA (United States); Radiation Therapy Oncology Group, Philadelphia, PA (United States); Ulin, Kenneth [Quality Assurance Review Center, Department of Radiation Oncology, University of Massachusetts Medical School, Lincoln, RI (United States); Department of Radiation Oncology, University of Massachusetts Medical School, Worcester, MA (United States); Xiao, Ying [Department of Radiation Oncology, Jefferson Medical College, Thomas Jefferson University, Philadelphia, PA (United States); Radiation Therapy Oncology Group, Philadelphia, PA (United States); FitzGerald, Thomas J., E-mail: dfollowi@mdanderson.org [Quality Assurance Review Center, Department of Radiation Oncology, University of Massachusetts Medical School, Lincoln, RI (United States); Department of Radiation Oncology, University of Massachusetts Medical School, Worcester, MA (United States)

    2012-12-26

    The National Cancer Institute (NCI) clinical cooperative groups have been instrumental over the past 50 years in developing clinical trials and evidence-based clinical trial processes for improvements in patient care. The cooperative groups are undergoing a transformation process to launch, conduct, and publish clinical trials more rapidly. Institutional participation in clinical trials can be made more efficient and include the expansion of relationships with international partners. This paper reviews the current processes that are in use in radiation therapy trials and the importance of maintaining effective credentialing strategies to assure the quality of the outcomes of clinical trials. The paper offers strategies to streamline and harmonize credentialing tools and processes moving forward as the NCI undergoes transformative change in the conduct of clinical trials.

  5. Clinical Trials in Noninfectious Uveitis

    Science.gov (United States)

    Kim, Jane S.; Knickelbein, Jared E.; Nussenblatt, Robert B.; Sen, H. Nida

    2015-01-01

    The treatment of noninfectious uveitis continues to remain a challenge for many ophthalmologists. Historically, clinical trials in uveitis have been sparse, and thus, most treatment decisions have largely been based on clinical experience and consensus guidelines. The current treatment paradigm favors initiation then tapering of corticosteroids with addition of steroid-sparing immunosuppressive agents for persistence or recurrence of disease. Unfortunately, in spite of a multitude of highly unfavorable systemic effects, corticosteroids are still regarded as the mainstay of treatment for many patients with chronic and refractory noninfectious uveitis. However, with the success of other conventional and biologic immunomodulatory agents in treating systemic inflammatory and autoimmune conditions, interest in targeted treatment strategies for uveitis has been renewed. Multiple clinical trials on steroid-sparing immunosuppressive agents, biologic agents, intraocular corticosteroid implants, and topical ophthalmic solutions have already been completed, and many more are ongoing. This review discusses the results and implications of these clinical trials investigating both alternative and novel treatment options for noninfectious uveitis. PMID:26035763

  6. Market Trials of Irradiated Spices

    International Nuclear Information System (INIS)

    Charoen, Saovapong; Eemsiri, Jaruratana; Sajjabut, Surasak

    2009-07-01

    Full text: The objectives of the experiment were to disseminate irradiated retail foods to the domestic publics and to test consumer acceptance on irradiated ground chilli and ground pepper. Market trials of irradiated ground chilli and ground pepper were carried out at 2 local markets and 4 in Bangkok and Nontaburi in 2005-2007. Before the start of the experiment, processing room, gamma irradiation room and labels of the products were approved by Food and Drug Administration, Thailand. 50 grams of irradiated products were packaged in plastic bags for the market trials. 688 and 738 bags of ground chilli and ground pepper were sold, respectively. Questionnaires distributed with the products were commented by 59 consumers and statistically analyzed by experimental data pass program. 88.1 and 91.4 percents of the consumers were satisfied with the quality and the price, respectively. 79.7% of the consumers chose to buy irradiated ground chilli and ground pepper because they believed that the quality of irradiated products were better than that of non-irradiated ones. 91.5% of the consumers would certainly buy irradiated chilli and pepper again. Through these market trials, it was found that all of the products were sold out and the majority of the consumers who returned the questionnaires was satisfied with the irradiated ground chilli and ground pepper and also had good attitude toward irradiated foods

  7. Clinical trials and gender medicine.

    Science.gov (United States)

    Cassese, Mariarita; Zuber, Veronica

    2011-01-01

    Women use more medicines than men because they fall ill more often and suffer more from chronic diseases, but also because women pay more attention to their health and have more consciousness and care about themselves. Although medicines can have different effects on women and men, women still represent a small percentage in the first phases of trials (22%) which are essential to verify drugs dosage, side effects, and safety. Even though women are more present in trials, studies results are not presented with a gender approach. This situation is due to educational, social, ethical and economical factors. The scientific research must increase feminine presence in clinical trials in order to be equal and correct, and all the key stakeholder should be involved in this process. We still have a long way to cover and it doesn't concern only women but also children and old people. The aim is to have a medicine not only illness-focused but patient-focused: a medicine able to take into consideration all the patient characteristics and so to produce a really personalized therapy. What above described is part of the reasons why in 2005 was founded the National Observatory for Women's Health (Osservatorio Nazionale sulla Salute della Donna, ONDa) which promotes a gender health awareness and culture in Italy, at all the levels of the civil and scientific society.

  8. Clinical trials and gender medicine

    Directory of Open Access Journals (Sweden)

    Mariarita Cassese

    2011-01-01

    Full Text Available Women use more medicines than men because they fall ill more often and suffer more from chronic diseases, but also because women pay more attention to their health and have more consciousness and care about themselves. Although medicines can have different effects on women and men, women still represent a small percentage in the first phases of trials (22% which are essential to verify drugs dosage, side effects, and safety. Even though women are more present in trials, studies results are not presented with a gender approach. This situation is due to educational, social, ethical and economical factors. The scientific research must increase feminine presence in clinical trials in order to be equal and correct, and all the key stakeholder should be involved in this process. We still have a long way to cover and it doesn't concern only women but also children and old people. The aim is to have a medicine not only illness-focused but patient-focused: a medicine able to take into consideration all the patient characteristics and so to produce a really personalized therapy. What above described is part of the reasons why in 2005 was founded the National Observatory for Women's Health (Osservatorio Nazionale sulla Salute della Donna, ONDa which promotes a gender health awareness and culture in Italy, at all the levels of the civil and scientific society.

  9. Informed consent in surgical trials.

    Science.gov (United States)

    Etchells, E

    1999-12-01

    All participants must provide a valid consent to surgical clinical trials. A valid consent requires patient capacity, adequate disclosure of information, and voluntariness. Capacity is the ability to understand information relevant to making a decision and to appreciate the reasonably foreseeable consequences of a decision or lack of decision. To protect vulnerable persons, an incapable person should not be enrolled in most clinical trials. The only exception is if the study can only be conducted on incapable persons. If the willing research participant is incapable, consent must be obtained from others through a process called substitute (or proxy) consent. Disclosure refers to the provision of relevant information to the patient and its comprehension by the patient. Most surgical trials carry more than minimal risks, so the requirement for careful disclosure of these risks to potential participants is generally stringent. Voluntariness refers to the freedom of a person to make a treatment decision. In specific circumstances related to emergency research, the requirement for consent may be waived. Waiver can be justified only if the delay required to obtain consent would prevent the research from occurring and only after prior consultation with from the "community" of potential research participants.

  10. Impact of a cancer clinical trials web site on discussions about trial participation: a cluster randomized trial.

    Science.gov (United States)

    Dear, R F; Barratt, A L; Askie, L M; Butow, P N; McGeechan, K; Crossing, S; Currow, D C; Tattersall, M H N

    2012-07-01

    Cancer patients want access to reliable information about currently recruiting clinical trials. Oncologists and their patients were randomly assigned to access a consumer-friendly cancer clinical trials web site [Australian Cancer Trials (ACT), www.australiancancertrials.gov.au] or to usual care in a cluster randomized controlled trial. The primary outcome, measured from audio recordings of oncologist-patient consultations, was the proportion of patients with whom participation in any clinical trial was discussed. Analysis was by intention-to-treat accounting for clustering and stratification. Thirty medical oncologists and 493 patients were recruited. Overall, 46% of consultations in the intervention group compared with 34% in the control group contained a discussion about clinical trials (P=0.08). The mean consultation length in both groups was 29 min (P=0.69). The proportion consenting to a trial was 10% in both groups (P=0.65). Patients' knowledge about randomized trials was lower in the intervention than the control group (mean score 3.0 versus 3.3, P=0.03) but decisional conflict scores were similar (mean score 42 versus 43, P=0.83). Good communication between patients and physicians is essential. Within this context, a web site such as Australian Cancer Trials may be an important tool to encourage discussion about clinical trial participation.

  11. Physical activity and trial-by-trial adjustments of response conflict.

    Science.gov (United States)

    Kamijo, Keita; Takeda, Yuji

    2013-08-01

    The relationship of physical activity to trial-by-trial adjustments of response conflict was assessed using behavioral task performance, the N2 event-related brain potential component, and phase-locking values (PLVs) in a lower gamma band during a perceptual conflict task. Nineteen physically active and 19 inactive young adults (mean age = 21.3 years) performed a Navon task, using a global letter made up of local letters of either the same kind (congruent trials) or a different kind (incongruent trials). Findings revealed that active individuals exhibited smaller N2 amplitudes and greater PLVs on incongruent trials that were preceded by incongruent trials compared with those preceded by congruent trials. Such phenomena were not observed for inactive individuals. These results suggest that greater physical activity is associated with larger trial-by-trial adjustments of response conflict, which we attribute to upregulation of top-down cognitive control and reductions in response conflict.

  12. Microbicide clinical trial adherence: insights for introduction.

    Science.gov (United States)

    Woodsong, Cynthia; MacQueen, Kathleen; Amico, K Rivet; Friedland, Barbara; Gafos, Mitzy; Mansoor, Leila; Tolley, Elizabether; McCormack, Sheena

    2013-04-08

    After two decades of microbicide clinical trials it remains uncertain if vaginally- delivered products will be clearly shown to reduce the risk of HIV infection in women and girls. Furthermore, a microbicide product with demonstrated clinical efficacy must be used correctly and consistently if it is to prevent infection. Information on adherence that can be gleaned from microbicide trials is relevant for future microbicide safety and efficacy trials, pre-licensure implementation trials, Phase IV post-marketing research, and microbicide introduction and delivery. Drawing primarily from data and experience that has emerged from the large-scale microbicide efficacy trials completed to-date, the paper identifies six broad areas of adherence lessons learned: (1) Adherence measurement in clinical trials, (2) Comprehension of use instructions/Instructions for use, (3) Unknown efficacy and its effect on adherence/Messages regarding effectiveness, (4) Partner influence on use, (5) Retention and continuation and (6) Generalizability of trial participants' adherence behavior. Each is discussed, with examples provided from microbicide trials. For each of these adherence topics, recommendations are provided for using trial findings to prepare for future microbicide safety and efficacy trials, Phase IV post-marketing research, and microbicide introduction and delivery programs.

  13. Critical concepts in adaptive clinical trials

    Directory of Open Access Journals (Sweden)

    Park JJH

    2018-03-01

    Full Text Available Jay JH Park,1 Kristian Thorlund,2,3 Edward J Mills2,3 1Department of Medicine, University of British Columbia, Vancouver, BC, Canada; 2Department of Health Research Methods, Evidence, and Impact (HEI, McMaster University, Hamilton, ON, Canada; 3The Bill and Melinda Gates Foundation, Seattle, WA, USA Abstract: Adaptive clinical trials are an innovative trial design aimed at reducing resources, decreasing time to completion and number of patients exposed to inferior interventions, and improving the likelihood of detecting treatment effects. The last decade has seen an increasing use of adaptive designs, particularly in drug development. They frequently differ importantly from conventional clinical trials as they allow modifications to key trial design components during the trial, as data is being collected, using preplanned decision rules. Adaptive designs have increased likelihood of complexity and also potential bias, so it is important to understand the common types of adaptive designs. Many clinicians and investigators may be unfamiliar with the design considerations for adaptive designs. Given their complexities, adaptive trials require an understanding of design features and sources of bias. Herein, we introduce some common adaptive design elements and biases and specifically address response adaptive randomization, sample size reassessment, Bayesian methods for adaptive trials, seamless trials, and adaptive enrichment using real examples. Keywords: adaptive designs, response adaptive randomization, sample size reassessment, Bayesian adaptive trials, seamless trials, adaptive enrichment

  14. Where are clinical trials going? Society and clinical trials.

    Science.gov (United States)

    Sleight, P

    2004-02-01

    Clinical trials now increasingly impinge on society at large. First there is growing emphasis from health organizations on the need for unbiased evidence about the effectiveness of promoted remedies. Second, as most novel treatments accrue increased costs to society, these need to be evaluated in terms of value for money. Third, there has been confusion and concern about the resolution of conflicting evidence, especially the role of advertising and commercial pressures from a powerful pharmaceutical industry motivated by profit. Fourth, there is concern about research fraud and the ethics of clinical trials. Fifth, there is increasing suspicion of political advice, which sometimes has sought to reassure an anxious public on the basis of complex and possibly inadequate scientific information. Some of these issues are addressed by truly independent and properly constituted data and safety monitoring committees, which are of particular importance when academic investigators or universities have a large financial conflict of interest. This is now more problematic with the current encouragement of investigator-led spin-off companies. These issues are best resolved by independent financial support (from government or other institutions) rather than relying on the commercial sponsor.

  15. Predictive value of diminutive colonic adenoma trial: the PREDICT trial.

    Science.gov (United States)

    Schoenfeld, Philip; Shad, Javaid; Ormseth, Eric; Coyle, Walter; Cash, Brooks; Butler, James; Schindler, William; Kikendall, Walter J; Furlong, Christopher; Sobin, Leslie H; Hobbs, Christine M; Cruess, David; Rex, Douglas

    2003-05-01

    Diminutive adenomas (1-9 mm in diameter) are frequently found during colon cancer screening with flexible sigmoidoscopy (FS). This trial assessed the predictive value of these diminutive adenomas for advanced adenomas in the proximal colon. In a multicenter, prospective cohort trial, we matched 200 patients with normal FS and 200 patients with diminutive adenomas on FS for age and gender. All patients underwent colonoscopy. The presence of advanced adenomas (adenoma >or= 10 mm in diameter, villous adenoma, adenoma with high grade dysplasia, and colon cancer) and adenomas (any size) was recorded. Before colonoscopy, patients completed questionnaires about risk factors for adenomas. The prevalence of advanced adenomas in the proximal colon was similar in patients with diminutive adenomas and patients with normal FS (6% vs. 5.5%, respectively) (relative risk, 1.1; 95% confidence interval [CI], 0.5-2.6). Diminutive adenomas on FS did not accurately predict advanced adenomas in the proximal colon: sensitivity, 52% (95% CI, 32%-72%); specificity, 50% (95% CI, 49%-51%); positive predictive value, 6% (95% CI, 4%-8%); and negative predictive value, 95% (95% CI, 92%-97%). Male gender (odds ratio, 1.63; 95% CI, 1.01-2.61) was associated with an increased risk of proximal colon adenomas. Diminutive adenomas on sigmoidoscopy may not accurately predict advanced adenomas in the proximal colon.

  16. Gatekeepers for pragmatic clinical trials.

    Science.gov (United States)

    Whicher, Danielle M; Miller, Jennifer E; Dunham, Kelly M; Joffe, Steven

    2015-10-01

    To successfully implement a pragmatic clinical trial, investigators need access to numerous resources, including financial support, institutional infrastructure (e.g. clinics, facilities, staff), eligible patients, and patient data. Gatekeepers are people or entities who have the ability to allow or deny access to the resources required to support the conduct of clinical research. Based on this definition, gatekeepers relevant to the US clinical research enterprise include research sponsors, regulatory agencies, payers, health system and other organizational leadership, research team leadership, human research protections programs, advocacy and community groups, and clinicians. This article provides a framework to help guide gatekeepers' decision-making related to the use of resources for pragmatic clinical trials. Relevant ethical considerations for gatekeepers include (1) concern for the interests of individuals, groups, and communities affected by the gatekeepers' decisions, including protection from harm and maximization of benefits; (2) advancement of organizational mission and values; and (3) stewardship of financial, human, and other organizational resources. Separate from these ethical considerations, gatekeepers' actions will be guided by relevant federal, state, and local regulations. This framework also suggests that to further enhance the legitimacy of their decision-making, gatekeepers should adopt transparent processes that engage relevant stakeholders when feasible and appropriate. We apply this framework to the set of gatekeepers responsible for making decisions about resources necessary for pragmatic clinical trials in the United States, describing the relevance of the criteria in different situations and pointing out where conflicts among the criteria and relevant regulations may affect decision-making. Recognition of the complex set of considerations that should inform decision-making will guide gatekeepers in making justifiable choices regarding

  17. Center-Within-Trial Versus Trial-Level Evaluation of Surrogate Endpoints

    Science.gov (United States)

    Renfro, Lindsay A.; Shi, Qian; Xue, Yuan; Li, Junlong; Shang, Hongwei; Sargent, Daniel J.

    2014-01-01

    Evaluation of candidate surrogate endpoints using individual patient data from multiple clinical trials is considered the gold standard approach to validate surrogates at both patient and trial levels. However, this approach assumes the availability of patient-level data from a relatively large collection of similar trials, which may not be possible to achieve for a given disease application. One common solution to the problem of too few similar trials involves performing trial-level surrogacy analyses on trial sub-units (e.g., centers within trials), thereby artificially increasing the trial-level sample size for feasibility of the multi-trial analysis. To date, the practical impact of treating trial sub-units (centers) identically to trials in multi-trial surrogacy analyses remains unexplored, and conditions under which this ad hoc solution may in fact be reasonable have not been identified. We perform a simulation study to identify such conditions, and demonstrate practical implications using a multi-trial dataset of patients with early stage colon cancer. PMID:25061255

  18. OARSI Clinical Trials Recommendations: Design and conduct of clinical trials of rehabilitation interventions for osteoarthritis.

    Science.gov (United States)

    Fitzgerald, G K; Hinman, R S; Zeni, J; Risberg, M A; Snyder-Mackler, L; Bennell, K L

    2015-05-01

    A Task Force of the Osteoarthritis Research Society International (OARSI) has previously published a set of guidelines for the conduct of clinical trials in osteoarthritis (OA) of the hip and knee. Limited material available on clinical trials of rehabilitation in people with OA has prompted OARSI to establish a separate Task Force to elaborate guidelines encompassing special issues relating to rehabilitation of OA. The Task Force identified three main categories of rehabilitation clinical trials. The categories included non-operative rehabilitation trials, post-operative rehabilitation trials, and trials examining the effectiveness of devices (e.g., assistive devices, bracing, physical agents, electrical stimulation, etc.) that are used in rehabilitation of people with OA. In addition, the Task Force identified two main categories of outcomes in rehabilitation clinical trials, which include outcomes related to symptoms and function, and outcomes related to disease modification. The guidelines for rehabilitation clinical trials provided in this report encompass these main categories. The report provides guidelines for conducting and reporting on randomized clinical trials. The topics include considerations for entering patients into trials, issues related to conducting trials, considerations for selecting outcome measures, and recommendations for statistical analyses and reporting of results. The focus of the report is on rehabilitation trials for hip, knee and hand OA, however, we believe the content is broad enough that it could be applied to rehabilitation trials for other regions as well. Copyright © 2015 Osteoarthritis Research Society International. Published by Elsevier Ltd. All rights reserved.

  19. Trial publication after registration in ClinicalTrials.Gov: a cross-sectional analysis.

    Directory of Open Access Journals (Sweden)

    Joseph S Ross

    2009-09-01

    Full Text Available ClinicalTrials.gov is a publicly accessible, Internet-based registry of clinical trials managed by the US National Library of Medicine that has the potential to address selective trial publication. Our objectives were to examine completeness of registration within ClinicalTrials.gov and to determine the extent and correlates of selective publication.We examined reporting of registration information among a cross-section of trials that had been registered at ClinicalTrials.gov after December 31, 1999 and updated as having been completed by June 8, 2007, excluding phase I trials. We then determined publication status among a random 10% subsample by searching MEDLINE using a systematic protocol, after excluding trials completed after December 31, 2005 to allow at least 2 y for publication following completion. Among the full sample of completed trials (n = 7,515, nearly 100% reported all data elements mandated by ClinicalTrials.gov, such as intervention and sponsorship. Optional data element reporting varied, with 53% reporting trial end date, 66% reporting primary outcome, and 87% reporting trial start date. Among the 10% subsample, less than half (311 of 677, 46% of trials were published, among which 96 (31% provided a citation within ClinicalTrials.gov of a publication describing trial results. Trials primarily sponsored by industry (40%, 144 of 357 were less likely to be published when compared with nonindustry/nongovernment sponsored trials (56%, 110 of 198; p<0.001, but there was no significant difference when compared with government sponsored trials (47%, 57 of 122; p = 0.22. Among trials that reported an end date, 75 of 123 (61% completed prior to 2004, 50 of 96 (52% completed during 2004, and 62 of 149 (42% completed during 2005 were published (p = 0.006.Reporting of optional data elements varied and publication rates among completed trials registered within ClinicalTrials.gov were low. Without greater attention to reporting of all data

  20. Inherited Retinal Degenerative Clinical Trial Network. Addendum

    Science.gov (United States)

    2013-10-01

    inherited orphan retinal degenerative diseases and dry age-related macular degeneration (AMD) through the conduct of clinical trials and other...design and conduct of effective and efficient clinical trials for inherited orphan retinal degenerative diseases and dry AMD; • Limited number and...linica l trial in the NEER network for autosomal dominant retinitis pigmentosa, and the ProgSTAR studies for Stargardt disease ) . As new interventions b

  1. Strategies to improve retention in randomised trials

    Science.gov (United States)

    Brueton, Valerie C; Tierney, Jayne; Stenning, Sally; Harding, Seeromanie; Meredith, Sarah; Nazareth, Irwin; Rait, Greta

    2013-01-01

    Background Loss to follow-up from randomised trials can introduce bias and reduce study power, affecting the generalisability, validity and reliability of results. Many strategies are used to reduce loss to follow-up and improve retention but few have been formally evaluated. Objectives To quantify the effect of strategies to improve retention on the proportion of participants retained in randomised trials and to investigate if the effect varied by trial strategy and trial setting. Search methods We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, PreMEDLINE, EMBASE, PsycINFO, DARE, CINAHL, Campbell Collaboration's Social, Psychological, Educational and Criminological Trials Register, and ERIC. We handsearched conference proceedings and publication reference lists for eligible retention trials. We also surveyed all UK Clinical Trials Units to identify further studies. Selection criteria We included eligible retention trials of randomised or quasi-randomised evaluations of strategies to increase retention that were embedded in 'host' randomised trials from all disease areas and healthcare settings. We excluded studies aiming to increase treatment compliance. Data collection and analysis We contacted authors to supplement or confirm data that we had extracted. For retention trials, we recorded data on the method of randomisation, type of strategy evaluated, comparator, primary outcome, planned sample size, numbers randomised and numbers retained. We used risk ratios (RR) to evaluate the effectiveness of the addition of strategies to improve retention. We assessed heterogeneity between trials using the Chi2 and I2 statistics. For main trials that hosted retention trials, we extracted data on disease area, intervention, population, healthcare setting, sequence generation and allocation concealment. Main results We identified 38 eligible retention trials. Included trials evaluated six broad types of strategies to improve retention. These

  2. Single-Trial Inference on Visual Attention

    DEFF Research Database (Denmark)

    Dyrholm, Mads; Kyllingsbæk, Søren; Vangkilde, Signe Allerup

    2011-01-01

    In this paper we take a step towards single-trial behavioral modeling within a Theory of Visual Attention (TVA). In selective attention tasks, such as the Partial Report paradigm, the subject is asked to ignore distractors and only report stimuli that belong to the target class. Nothing about...... Report trial. This result retrodicts a latent attentional state of the subject using the observed response from that particular trial and thus differs from other predictions made with TVA which are based on expected values of observed variables. We show an example of the result in single-trial analysis...

  3. Power analysis of trials with multilevel data

    CERN Document Server

    Moerbeek, Mirjam

    2015-01-01

    Power Analysis of Trials with Multilevel Data covers using power and sample size calculations to design trials that involve nested data structures. The book gives a thorough overview of power analysis that details terminology and notation, outlines key concepts of statistical power and power analysis, and explains why they are necessary in trial design. It guides you in performing power calculations with hierarchical data, which enables more effective trial design.The authors are leading experts in the field who recognize that power analysis has attracted attention from applied statisticians i

  4. Inactive trials of transport systems

    International Nuclear Information System (INIS)

    Haberlin, M.M.; Hardy, A.R.

    1985-06-01

    The design and manufacture of a mock-up of a crate handling and size reduction (CHSR) facility, an experimental programme on the evaluation of a commercial air-transporter, and the selection, manufacture and commissioning trials of an integrated conveyor system for transporting crated waste into and within the mock-up facility, are considered. The mock-up facility was used for the test programme on the air-transporter and conveyor system. The air-transporter was considered suitable for transporting waste on the metal floor in the main dismantling area of the CHSR facility because it can tolerate asymmetric loading, the exhaust air flow liberated from the air-pads is low and it has excellent manoeuvrability. Commissioning trials were carried out on a commercial conveyor system consisting of unpowered rollers in the reception area, a powered slatted conveyor in the air-lock and an unpowered roller table placed on the air-transporter in the working area. It was demonstrated that a large asymmetrically loaded wooden crate can be transported into and within the facility by this method. Further design and experimental work necessary before the system can be used for remote operation is discussed. (author)

  5. The L'Aquila trial

    Science.gov (United States)

    Amato, Alessandro; Cocco, Massimo; Cultrera, Giovanna; Galadini, Fabrizio; Margheriti, Lucia; Nostro, Concetta; Pantosti, Daniela

    2013-04-01

    The first step of the trial in L'Aquila (Italy) ended with a conviction of a group of seven experts to 6 years of jail and several million euros refund for the families of the people who died during the Mw 6.3 earthquake on April 6, 2009. This verdict has a tremendous impact on the scientific community as well as on the way in which scientists deliver their expert opinions to decision makers and society. In this presentation, we describe the role of scientists in charge of releasing authoritative information concerning earthquakes and seismic hazard and the conditions that led to the verdict, in order to discuss whether this trial represented a prosecution to science, and if errors were made in communicating the risk. Documents, articles and comments about the trial are collected in the web site http://processoaquila.wordpress.com/. We will first summarize what was the knowledge about the seismic hazard of the region and the vulnerability of L'Aquila before the meeting of the National Commission for Forecasting and Predicting Great Risks (CGR) held 6 days before the main shock. The basic point of the accusation is that the CGR suggested that no strong earthquake would have occurred (which of course was never mentioned by any seismologist participating to the meeting). This message would have convinced the victims to stay at home, instead of moving out after the M3.9 and M3.5 earthquakes few hours before the mainshock. We will describe how the available scientific information was passed to the national and local authorities, and in general how the Italian scientific Institution in charge of seismic monitoring and research (INGV), the Civil Protection Department (DPC) and the CGR should interact according to the law. As far as the communication and outreach to the public, the scientific Institutions as INGV have the duty to communicate scientific information. Instead, the risk management and the definition of actions for risk reduction is in charge of Civil

  6. Comparison of reporting phase I trial results in ClinicalTrials.gov and matched publications.

    Science.gov (United States)

    Shepshelovich, D; Goldvaser, H; Wang, L; Abdul Razak, A R; Bedard, P L

    2017-12-01

    Background Data on completeness of reporting of phase I cancer clinical trials in publications are lacking. Methods The ClinicalTrials.gov database was searched for completed adult phase I cancer trials with reported results. PubMed was searched for matching primary publications published prior to November 1, 2016. Reporting in primary publications was compared with the ClinicalTrials.gov database using a 28-point score (2=complete; 1=partial; 0=no reporting) for 14 items related to study design, outcome measures and safety profile. Inconsistencies between primary publications and ClinicalTrials.gov were recorded. Linear regression was used to identify factors associated with incomplete reporting. Results After a review of 583 trials in ClinicalTrials.gov , 163 matching primary publications were identified. Publications reported outcomes that did not appear in ClinicalTrials.gov in 25% of trials. Outcomes were upgraded, downgraded or omitted in publications in 47% of trials. The overall median reporting score was 23/28 (interquartile range 21-25). Incompletely reported items in >25% publications were: inclusion criteria (29%), primary outcome definition (26%), secondary outcome definitions (53%), adverse events (71%), serious adverse events (80%) and dates of study start and database lock (91%). Higher reporting scores were associated with phase I (vs phase I/II) trials (ppublication in journals with lower impact factor (p=0.004). Conclusions Reported results in primary publications for early phase cancer trials are frequently inconsistent or incomplete compared with ClinicalTrials.gov entries. ClinicalTrials.gov may provide more comprehensive data from new cancer drug trials.

  7. Trial Sequential Methods for Meta-Analysis

    Science.gov (United States)

    Kulinskaya, Elena; Wood, John

    2014-01-01

    Statistical methods for sequential meta-analysis have applications also for the design of new trials. Existing methods are based on group sequential methods developed for single trials and start with the calculation of a required information size. This works satisfactorily within the framework of fixed effects meta-analysis, but conceptual…

  8. Challenges in conducting clinical trials in nephrology

    DEFF Research Database (Denmark)

    Baigent, Colin; Herrington, William G; Coresh, Josef

    2017-01-01

    Despite the high costs of treatment of people with kidney disease and associated comorbid conditions, the amount of reliable information available to guide the care of such patients is very limited. Some treatments have been assessed in randomized trials, but most such trials have been too small ...

  9. Blinded trials taken to the test

    DEFF Research Database (Denmark)

    Hróbjartsson, A; Forfang, E; Haahr, M T

    2007-01-01

    Blinding can reduce bias in randomized clinical trials, but blinding procedures may be unsuccessful. Our aim was to assess how often randomized clinical trials test the success of blinding, the methods involved and how often blinding is reported as being successful....

  10. RTOG: Updated results of randomized trials

    International Nuclear Information System (INIS)

    Curran, Walter J.

    1997-01-01

    Objective: To review the background, rationale and available results for recently completed randomized comparative clinical trials of the Radiation Therapy Oncology Group (RTOG), including inter group trials in which the RTOG has been the managing group or a major participant. When available, laboratory studies will be correlated with clinical results

  11. Clinical Trials Management | Division of Cancer Prevention

    Science.gov (United States)

    Information for researchers about developing, reporting, and managing NCI-funded cancer prevention clinical trials. Protocol Information Office The central clearinghouse for clinical trials management within the Division of Cancer Prevention.Read more about the Protocol Information Office. | Information for researchers about developing, reporting, and managing NCI-funded

  12. Controversy, Trials, and Crime--Oh My!

    Science.gov (United States)

    Rott, Kim

    2006-01-01

    Teenagers' innate interest with the justice system is one of the reasons that so many high school literary classics teem with criminals, controversial issues, and trials. Novels such as "To Kill a Mockingbird," "A Separate Peace," "The Crucible," and "Twelve Angry Men" feature high-impact trials. In the author's desire to tap into this interest,…

  13. Alien wavelength modeling tool and field trial

    DEFF Research Database (Denmark)

    Sambo, N.; Sgambelluri, A.; Secondini, M.

    2015-01-01

    A modeling tool is presented for pre-FEC BER estimation of PM-QPSK alien wavelength signals. A field trial is demonstrated and used as validation of the tool's correctness. A very close correspondence between the performance of the field trial and the one predicted by the modeling tool has been...

  14. Maximizing scientific knowledge from randomized clinical trials

    DEFF Research Database (Denmark)

    Gustafsson, Finn; Atar, Dan; Pitt, Bertram

    2010-01-01

    , in particular with respect to collaboration with the trial sponsor and to analytic pitfalls. The advantages of creating screening databases in conjunction with a given clinical trial are described; and finally, the potential for posttrial database studies to become a platform for training young scientists...

  15. The Eichmann Trial on East German Television

    NARCIS (Netherlands)

    Keilbach, Judith

    2014-01-01

    abstractThe trial against Adolf Eichmann was one of the first transnational media events on television. Its world-wide coverage required transnational cooperation. Using East German television reports about the trial this article argues that although the event transcended national borders it

  16. The Eichmann Trial on East German Television

    Directory of Open Access Journals (Sweden)

    Judith Keilbach

    2014-06-01

    Full Text Available The trial against Adolf Eichmann was one of the first transnational media events on television. Its world-wide coverage required transnational cooperation. Using East German television reports about the trial this article argues that although the event transcended national borders it maintained at the same time ideological boundaries.

  17. Internet trials: participant experiences and perspectives.

    Science.gov (United States)

    Mathieu, Erin; Barratt, Alexandra; Carter, Stacy M; Jamtvedt, Gro

    2012-10-23

    Use of the Internet to conduct randomised controlled trials is increasing, and provides potential to increase equity of access to medical research, increase the generalisability of trial results and decrease the costs involved in conducting large scale trials. Several studies have compared response rates, completeness of data, and reliability of surveys using the Internet and traditional methods, but very little is known about participants' attitudes towards Internet-based randomised trials or their experience of participating in an Internet-based trial. To obtain insights into the experiences and perspectives of participants in an Internet-based randomised controlled trial, their attitudes to the use of the Internet to conduct medical research, and their intentions regarding future participation in Internet research. All English speaking participants in a recently completed Internet randomised controlled trial were invited to participate in an online survey. 1246 invitations were emailed. 416 participants completed the survey between May and October 2009 (33% response rate). Reasons given for participating in the Internet RCT fell into 4 main areas: personal interest in the research question and outcome, ease of participation, an appreciation of the importance of research and altruistic reasons. Participants' comments and reflections on their experience of participating in a fully online trial were positive and less than half of participants would have participated in the trial had it been conducted using other means of data collection. However participants identified trade-offs between the benefits and downsides of participating in Internet-based trials. The main trade-off was between flexibility and convenience - a perceived benefit - and a lack connectedness and understanding - a perceived disadvantage. The other tradeoffs were in the areas of: ease or difficulty in use of the Internet; security, privacy and confidentiality issues; perceived benefits and

  18. Terrorists on Trial: A Performative Perspective

    Directory of Open Access Journals (Sweden)

    Beatrice de Graaf

    2011-03-01

    Full Text Available On 30 March 2011, ICCT organised an Expert Meeting entitled “Terrorism Trials as Theatre: A Performative Perspective”. The Expert Meeting applied a performative perspective to three well known and recent trials in different parts of the world: the trials against the Dutch Hofstad Group, the Mumbai 2008 Terrorist Attack Trial and the Guantanamo Military Tribunals. As such, the Expert Meeting did not concentrate solely on the immediate judicial performance of the magistrates and/or the defence; instead, the trials were put in their wider sociological context, adopting notions of social drama and communication sciences. This Expert Meeting Paper is a further adaptation of the Discussion Paper that was used as basis for debate during the Meeting.

  19. Strategies to improve recruitment to randomised trials.

    Science.gov (United States)

    Treweek, Shaun; Pitkethly, Marie; Cook, Jonathan; Fraser, Cynthia; Mitchell, Elizabeth; Sullivan, Frank; Jackson, Catherine; Taskila, Tyna K; Gardner, Heidi

    2018-02-22

    Recruiting participants to trials can be extremely difficult. Identifying strategies that improve trial recruitment would benefit both trialists and health research. To quantify the effects of strategies for improving recruitment of participants to randomised trials. A secondary objective is to assess the evidence for the effect of the research setting (e.g. primary care versus secondary care) on recruitment. We searched the Cochrane Methodology Review Group Specialised Register (CMR) in the Cochrane Library (July 2012, searched 11 February 2015); MEDLINE and MEDLINE In Process (OVID) (1946 to 10 February 2015); Embase (OVID) (1996 to 2015 Week 06); Science Citation Index & Social Science Citation Index (ISI) (2009 to 11 February 2015) and ERIC (EBSCO) (2009 to 11 February 2015). Randomised and quasi-randomised trials of methods to increase recruitment to randomised trials. This includes non-healthcare studies and studies recruiting to hypothetical trials. We excluded studies aiming to increase response rates to questionnaires or trial retention and those evaluating incentives and disincentives for clinicians to recruit participants. We extracted data on: the method evaluated; country in which the study was carried out; nature of the population; nature of the study setting; nature of the study to be recruited into; randomisation or quasi-randomisation method; and numbers and proportions in each intervention group. We used a risk difference to estimate the absolute improvement and the 95% confidence interval (CI) to describe the effect in individual trials. We assessed heterogeneity between trial results. We used GRADE to judge the certainty we had in the evidence coming from each comparison. We identified 68 eligible trials (24 new to this update) with more than 74,000 participants. There were 63 studies involving interventions aimed directly at trial participants, while five evaluated interventions aimed at people recruiting participants. All studies were in

  20. Marketing and clinical trials: a case study

    Directory of Open Access Journals (Sweden)

    Entwistle Vikki A

    2007-11-01

    Full Text Available Abstract Background Publicly funded clinical trials require a substantial commitment of time and money. To ensure that sufficient numbers of patients are recruited it is essential that they address important questions in a rigorous manner and are managed well, adopting effective marketing strategies. Methods Using methods of analysis drawn from management studies, this paper presents a structured assessment framework or reference model, derived from a case analysis of the MRC's CRASH trial, of 12 factors that may affect the success of the marketing and sales activities associated with clinical trials. Results The case study demonstrates that trials need various categories of people to buy in – hence, to be successful, trialists must embrace marketing strategies to some extent. Conclusion The performance of future clinical trials could be enhanced if trialists routinely considered these factors.

  1. Marketing and clinical trials: a case study.

    Science.gov (United States)

    Francis, David; Roberts, Ian; Elbourne, Diana R; Shakur, Haleema; Knight, Rosemary C; Garcia, Jo; Snowdon, Claire; Entwistle, Vikki A; McDonald, Alison M; Grant, Adrian M; Campbell, Marion K

    2007-11-20

    Publicly funded clinical trials require a substantial commitment of time and money. To ensure that sufficient numbers of patients are recruited it is essential that they address important questions in a rigorous manner and are managed well, adopting effective marketing strategies. Using methods of analysis drawn from management studies, this paper presents a structured assessment framework or reference model, derived from a case analysis of the MRC's CRASH trial, of 12 factors that may affect the success of the marketing and sales activities associated with clinical trials. The case study demonstrates that trials need various categories of people to buy in - hence, to be successful, trialists must embrace marketing strategies to some extent. The performance of future clinical trials could be enhanced if trialists routinely considered these factors.

  2. Ethics of clinical trials in Nigeria.

    Science.gov (United States)

    Okonta, Patrick I

    2014-05-01

    The conduct of clinical trials for the development and licensing of drugs is a very important aspect of healthcare. Drug research, development and promotion have grown to a multi-billion dollar global business. Like all areas of human endeavour involving generation and control of huge financial resources, it could be subject to deviant behaviour, sharp business practices and unethical practices. The main objective of this review is to highlight potential ethical challenges in the conduct of clinical trials in Nigeria and outline ways in which these can be avoided. Current international and national regulatory and ethical guidelines are reviewed to illustrate the requirements for ethical conduct of clinical trials. Past experiences of unethical conduct of clinical trials especially in developing countries along with the increasing globalisation of research makes it imperative that all players should be aware of the ethical challenges in clinical trials and the benchmarks for ethical conduct of clinical research in Nigeria.

  3. Reinventing clinical trials: a review of innovative biomarker trial designs in cancer therapies.

    Science.gov (United States)

    Lin, Ja-An; He, Pei

    2015-06-01

    Recently, new clinical trial designs involving biomarkers have been studied and proposed in cancer clinical research, in the hope of incorporating the rapid growing basic research into clinical practices. Journal articles related to various biomarkers and their role in cancer clinical trial, articles and books about statistical issues in trial design, and regulatory website, documents, and guidance for submission of targeted cancer therapies. The drug development process involves four phases. The confirmatory Phase III is essential in regulatory approval of a special treatment. Regulatory agency has restrictions on confirmatory trials 'using adaptive designs'. No rule of thumb to pick the most appropriate design for biomarker-related trials. Statistical issues to solve in new designs. Regulatory acceptance of the 'newly proposed trial designs'. Biomarker-related trial designs that can resolve the statistical issues and satisfy the regulatory requirement. © The Author 2015. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

  4. Recruitment to publicly funded trials--are surgical trials really different?

    Science.gov (United States)

    Cook, Jonathan A; Ramsay, Craig R; Norrie, John

    2008-09-01

    Good recruitment is integral to the conduct of a high-quality randomised controlled trial. It has been suggested that recruitment is particularly difficult for evaluations of surgical interventions, a field in which there is a dearth of evidence from randomised comparisons. While there is anecdotal speculation to support the inference that recruitment to surgical trials is more challenging than for medical trials we are unaware of any formal assessment of this. In this paper, we compare recruitment to surgical and medical trials using a cohort of publicly funded trials. Overall recruitment to trials was assessed using of a cohort of publicly funded trials (n=114). Comparisons were made by using the Recruitment Index, a simple measure of recruitment activity for multicentre randomised controlled trials. Recruitment at the centre level was also investigated through three example surgical trials. The Recruitment Index was found to be higher, though not statistically significantly, in the surgical group (n=18, median=38.0 IQR (10.7, 77.4)) versus (n=81, median=34.8 IQR (11.7, 98.0)) days per recruit for the medical group (median difference 1.7 (-19.2, 25.1); p=0.828). For the trials where the comparison was between a surgical and a medical intervention, the Recruitment Index was substantially higher (n=6, 68.3 (23.5, 294.8)) versus (n=93, 34.6 (11.7, 90.0); median difference 25.9 (-35.5, 221.8); p=0.291) for the other trials. There was no clear evidence that surgical trials differ from medical trials in terms of recruitment activity. There was, however, support for the inference that medical versus surgical trials are more difficult to recruit to. Formal exploration of the recruitment data through a modelling approach may go some way to tease out where important differences exist.

  5. Trial of Repeated Analgesia with Kangaroo Mother Care (TRAKC Trial)

    Science.gov (United States)

    2013-01-01

    preferred standard of care. However, current pain management guidelines are based on minimal data on repeated use of either intervention. Therefore, regardless of the outcomes of this study, results will have important implications for guidelines and practices related to management of procedural pain in preterm infants. Trial registration ClinicalTrials.gov Identifier: NCT01561547. PMID:24284002

  6. Disclosure of investigators' recruitment performance in multicenter clinical trials

    DEFF Research Database (Denmark)

    Dal-Ré, Rafael; Moher, David; Gluud, Christian

    2011-01-01

    Rafael Dal-Ré and colleagues argue that the recruitment targets and performance of all site investigators in multi-centre clinical trials should be disclosed in trial registration sites before a trial starts, and when it ends.......Rafael Dal-Ré and colleagues argue that the recruitment targets and performance of all site investigators in multi-centre clinical trials should be disclosed in trial registration sites before a trial starts, and when it ends....

  7. Re-Engineering Alzheimer Clinical Trials: Global Alzheimer's Platform Network.

    Science.gov (United States)

    Cummings, J; Aisen, P; Barton, R; Bork, J; Doody, R; Dwyer, J; Egan, J C; Feldman, H; Lappin, D; Truyen, L; Salloway, S; Sperling, R; Vradenburg, G

    2016-06-01

    Alzheimer's disease (AD) drug development is costly, time-consuming, and inefficient. Trial site functions, trial design, and patient recruitment for trials all require improvement. The Global Alzheimer Platform (GAP) was initiated in response to these challenges. Four GAP work streams evolved in the US to address different trial challenges: 1) registry-to-cohort web-based recruitment; 2) clinical trial site activation and site network construction (GAP-NET); 3) adaptive proof-of-concept clinical trial design; and 4) finance and fund raising. GAP-NET proposes to establish a standardized network of continuously funded trial sites that are highly qualified to perform trials (with established clinical, biomarker, imaging capability; certified raters; sophisticated management system. GAP-NET will conduct trials for academic and biopharma industry partners using standardized instrument versions and administration. Collaboration with the Innovative Medicines Initiative (IMI) European Prevention of Alzheimer's Disease (EPAD) program, the Canadian Consortium on Neurodegeneration in Aging (CCNA) and other similar international initiatives will allow conduct of global trials. GAP-NET aims to increase trial efficiency and quality, decrease trial redundancy, accelerate cohort development and trial recruitment, and decrease trial costs. The value proposition for sites includes stable funding and uniform training and trial execution; the value to trial sponsors is decreased trial costs, reduced time to execute trials, and enhanced data quality. The value for patients and society is the more rapid availability of new treatments for AD.

  8. From randomised trials to rational practice.

    Science.gov (United States)

    van Gijn, J

    2005-01-01

    From the age of Enlightenment onwards, philosophical thinking has become increasingly influenced by empiricism: observations lead to theories, but experiments are needed to put the reasoning to the test. However, it was not until the middle of the 20th century that well-designed experiments were at last introduced in medical treatment, in the form of randomised controlled clinical trials. This design is now standard in medicine, but in everyday practice a multitude of management decisions must still be taken without good evidence. There are several reasons for this: there may not be a trial at all or only a single trial; trial results may be equivocal; patients may be different from those enrolled in trials; new procedures require practice, or a trial may not be feasible. 'Logical reasoning', with all its fallacies, is still required - not only to fill the gaps in empirical knowledge but also to interpret existing evidence and to plan new trials. In fact, the generation of new knowledge is a continuous, cyclical process in which newly gained insights in pathophysiology give rise to new therapeutic experiments, the results of which generate fresh hypotheses, and so on. Compassion, curiosity and doubt are the essential forces that keep the cycle moving. Conversely, the progress is slowed down by present-day legalism, which distorts investigator accountability and patient autonomy. Copyright (c) 2005 S. Karger AG, Basel.

  9. Clinical trial registration in oral health journals.

    Science.gov (United States)

    Smaïl-Faugeron, V; Fron-Chabouis, H; Durieux, P

    2015-03-01

    Prospective registration of randomized controlled trials (RCTs) represents the best solution to reporting bias. The extent to which oral health journals have endorsed and complied with RCT registration is unknown. We identified journals publishing RCTs in dentistry, oral surgery, and medicine in the Journal Citation Reports. We classified journals into 3 groups: journals requiring or recommending trial registration, journals referring indirectly to registration, and journals providing no reference to registration. For the 5 journals with the highest 2012 impact factors in each group, we assessed whether RCTs with results published in 2013 had been registered. Of 78 journals examined, 32 (41%) required or recommended trial registration, 19 (24%) referred indirectly to registration, and 27 (35%) provided no reference to registration. We identified 317 RCTs with results published in the 15 selected journals in 2013. Overall, 73 (23%) were registered in a trial registry. Among those, 91% were registered retrospectively and 32% did not report trial registration in the published article. The proportion of trials registered was not significantly associated with editorial policies: 29% with results in journals that required or recommended registration, 15% in those that referred indirectly to registration, and 21% in those providing no reference to registration (P = 0.05). Less than one-quarter of RCTs with results published in a sample of oral health journals were registered with a public registry. Improvements are needed with respect to how journals inform and require their authors to register their trials. © International & American Associations for Dental Research.

  10. Geographic differences in heart failure trials.

    Science.gov (United States)

    Ferreira, João Pedro; Girerd, Nicolas; Rossignol, Patrick; Zannad, Faiez

    2015-09-01

    Randomized controlled trials (RCTs) are essential to develop advances in heart failure (HF). The need for increasing numbers of patients (without substantial cost increase) and generalization of results led to the disappearance of international boundaries in large RCTs. The significant geographic differences in patients' characteristics, outcomes, and, most importantly, treatment effect observed in HF trials have recently been highlighted. Whether the observed regional discrepancies in HF trials are due to trial-specific issues, patient heterogeneity, structural differences in countries, or a complex interaction between factors are the questions we propose to debate in this review. To do so, we will analyse and review data from HF trials conducted in different world regions, from heart failure with preserved ejection fraction (HF-PEF), heart failure with reduced ejection fraction (HF-REF), and acute heart failure (AHF). Finally, we will suggest objective and actionable measures in order to mitigate regional discrepancies in future trials, particularly in HF-PEF where prognostic modifying treatments are urgently needed and in which trials are more prone to selection bias, due to a larger patient heterogeneity. © 2015 The Authors European Journal of Heart Failure © 2015 European Society of Cardiology.

  11. The clinically-integrated randomized trial: proposed novel method for conducting large trials at low cost

    Directory of Open Access Journals (Sweden)

    Scardino Peter T

    2009-03-01

    Full Text Available Abstract Introduction Randomized controlled trials provide the best method of determining which of two comparable treatments is preferable. Unfortunately, contemporary randomized trials have become increasingly expensive, complex and burdened by regulation, so much so that many trials are of doubtful feasibility. Discussion Here we present a proposal for a novel, streamlined approach to randomized trials: the "clinically-integrated randomized trial". The key aspect of our methodology is that the clinical experience of the patient and doctor is virtually indistinguishable whether or not the patient is randomized, primarily because outcome data are obtained from routine clinical data, or from short, web-based questionnaires. Integration of a randomized trial into routine clinical practice also implies that there should be an attempt to randomize every patient, a corollary of which is that eligibility criteria are minimized. The similar clinical experience of patients on- and off-study also entails that the marginal cost of putting an additional patient on trial is negligible. We propose examples of how the clinically-integrated randomized trial might be applied in four distinct areas of medicine: comparisons of surgical techniques, "me too" drugs, rare diseases and lifestyle interventions. Barriers to implementing clinically-integrated randomized trials are discussed. Conclusion The proposed clinically-integrated randomized trial may allow us to enlarge dramatically the number of clinical questions that can be addressed by randomization.

  12. Are multiple-trial experiments appropriate for eyewitness identification studies? Accuracy, choosing, and confidence across trials.

    Science.gov (United States)

    Mansour, J K; Beaudry, J L; Lindsay, R C L

    2017-12-01

    Eyewitness identification experiments typically involve a single trial: A participant views an event and subsequently makes a lineup decision. As compared to this single-trial paradigm, multiple-trial designs are more efficient, but significantly reduce ecological validity and may affect the strategies that participants use to make lineup decisions. We examined the effects of a number of forensically relevant variables (i.e., memory strength, type of disguise, degree of disguise, and lineup type) on eyewitness accuracy, choosing, and confidence across 12 target-present and 12 target-absent lineup trials (N = 349; 8,376 lineup decisions). The rates of correct rejections and choosing (across both target-present and target-absent lineups) did not vary across the 24 trials, as reflected by main effects or interactions with trial number. Trial number had a significant but trivial quadratic effect on correct identifications (OR = 0.99) and interacted significantly, but again trivially, with disguise type (OR = 1.00). Trial number did not significantly influence participants' confidence in correct identifications, confidence in correct rejections, or confidence in target-absent selections. Thus, multiple-trial designs appear to have minimal effects on eyewitness accuracy, choosing, and confidence. Researchers should thus consider using multiple-trial designs for conducting eyewitness identification experiments.

  13. Parents' perceived obstacles to pediatric clinical trial participation: Findings from the clinical trials transformation initiative.

    Science.gov (United States)

    Greenberg, Rachel G; Gamel, Breck; Bloom, Diane; Bradley, John; Jafri, Hasan S; Hinton, Denise; Nambiar, Sumathi; Wheeler, Chris; Tiernan, Rosemary; Smith, P Brian; Roberts, Jamie; Benjamin, Daniel K

    2018-03-01

    Enrollment of children into pediatric clinical trials remains challenging. More effective strategies to improve recruitment of children into trials are needed. This study used in-depth qualitative interviews with parents who were approached to enroll their children in a clinical trial in order to gain an understanding of the barriers to pediatric clinical trial participation. Twenty-four parents whose children had been offered the opportunity to participate in a clinical trial were interviewed: 19 whose children had participated in at least 1 clinical trial and 5 who had declined participation in any trial. Each study aspect, from the initial explanation of the study to the end of the study, can affect the willingness of parents to consent to the proposed study and future studies. Establishing trust, appropriate timing, a transparent discussion of risks and benefits oriented to the layperson, and providing motivation for children to participate were key factors that impacted parents' decisions. In order for clinical trial accrual to be successful, parents' priorities and considerations must be a central focus, beginning with initial trial design. The recommendations from the parents who participated in this study can be used to support budget allocations that ensure adequate training of study staff and improved staffing on nights and weekends. Studies of parent responses in outpatient settings and additional inpatient settings will provide valuable information on the consent process from the child's and parent's perspectives. Further studies are needed to explore whether implementation of such strategies will result in improved recruitment for pediatric clinical trials.

  14. The Mycotic Ulcer Treatment Trial

    Science.gov (United States)

    Prajna, N. Venkatesh; Krishnan, Tiruvengada; Mascarenhas, Jeena; Rajaraman, Revathi; Prajna, Lalitha; Srinivasan, Muthiah; Raghavan, Anita; Oldenburg, Catherine E.; Ray, Kathryn J.; Zegans, Michael E.; McLeod, Stephen D.; Porco, Travis C.; Acharya, Nisha R.; Lietman, Thomas M.

    2013-01-01

    Objective To compare topical natamycin vs voriconazole in the treatment of filamentous fungal keratitis. Methods This phase 3, double-masked, multicenter trial was designed to randomize 368 patients to voriconazole (1%) or natamycin (5%), applied topically every hour while awake until reepithelialization, then 4 times daily for at least 3 weeks. Eligibility included smear-positive filamentous fungal ulcer and visual acuity of 20/40 to 20/400. Main Outcome Measures The primary outcome was best spectacle-corrected visual acuity at 3 months; secondary outcomes included corneal perforation and/or therapeutic penetrating keratoplasty. Results A total of 940 patients were screened and 323 were enrolled. Causative organisms included Fusarium (128 patients [40%]), Aspergillus (54 patients [17%]), and other filamentous fungi (141 patients [43%]). Natamycin-treated cases had significantly better 3-month best spectacle-corrected visual acuity than voriconazole-treated cases (regression coefficient=−0.18 logMAR; 95% CI, −0.30 to −0.05; P=.006). Natamycin-treated cases were less likely to have perforation or require therapeutic penetrating keratoplasty (odds ratio=0.42; 95% CI, 0.22 to 0.80; P=.009). Fusarium cases fared better with natamycin than with voriconazole (regression coefficient=−0.41 logMAR; 95% CI, −0.61 to −0.20; P<.001; odds ratio for perforation=0.06; 95% CI, 0.01 to 0.28; P<.001), while non-Fusarium cases fared similarly (regression coefficient=−0.02 logMAR; 95% CI, −0.17 to 0.13; P=.81; odds ratio for perforation=1.08; 95% CI, 0.48 to 2.43; P=.86). Conclusions Natamycin treatment was associated with significantly better clinical and microbiological outcomes than voriconazole treatment for smear-positive filamentous fungal keratitis, with much of the difference attributable to improved results in Fusarium cases. Application to Clinical Practice Voriconazole should not be used as monotherapy in filamentous keratitis. Trial Registration

  15. Juvenile offenders: competence to stand trial.

    Science.gov (United States)

    Soulier, Matthew

    2012-12-01

    This article details the legal background and assists the reader in the preparation and practical conduct of evaluations regarding juvenile adjudicative competency. The material is presented to be useful as a guide to direct questions of competency and covers aspects of evaluation that include: legal standard for competency to stand trial, developmental immaturity, current practice in juvenile competency to stand trial, forensic evaluation of juvenile competency to stand trial, organizing the evaluation, collateral sources of information, psychiatric evaluation of juvenile adjudicative competency, assessment of mental disorder and intellectual disability, assessment of developmental status, assessment of functional abilities for adjudicative competence, and reaching the forensic opinion. Copyright © 2012 Elsevier Inc. All rights reserved.

  16. Provenance trials of larch in Siberia

    Energy Technology Data Exchange (ETDEWEB)

    Milyutin, L.I. [V.N. Sukachev Inst. of Forest SB RAS, Krasnoyarsk (Russian Federation)

    1995-12-31

    Some results of provenance trials of larch in Siberia are given. These provenance trials were established in the last thirty years by efforts of V.N. Sukaczev Inst. of Forest. Provenances and species of larch were tested in some field trials distributed over Siberia between Lat. N 52 deg and 66 deg, Long. E 88 deg and 113 deg: near Krasnoyarsk, in Republic Khakasia (an altitudes of 800 and 1200 metres), in the Lower Yenisei near Turukhansk, in the west and south regions of Krasnoyarsk territory, in the Upper Lena, near Chita. 2 refs

  17. Clinical trials: bringing research to the bedside.

    Science.gov (United States)

    Arvay, C A

    1991-02-01

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

  18. Solid oxide fuel cell field trial evaluation

    Energy Technology Data Exchange (ETDEWEB)

    Wilcox, C.P.; Winstanley, R.; Nietsch, T.; Smith, C.; Knight, R.; Seymore, C.

    2000-07-01

    This report focuses on issues relating to a field trial of a solid oxide fuel cell (SOFC). Aspects examined include markets for SOFC systems, the choice of systems for demonstration in year 2002, the assessment of industrial interest, and evaluation and ranking of candidate systems. The identification and evaluation of interest in field trials, the estimation of the capital and running costs of a field trial, and identification of the benefits to the UK and barriers to implementation of SOFC systems are discussed. (UK)

  19. Inherited Retinal Degenerative Clinical Trial Network

    Science.gov (United States)

    2009-10-01

    clinical efforts that will impact the NEER network going forward and laid the ground work for the CTECs to participate in ongoing clinical trials for...Clinical Implications: • How will the proposed clinical trial have a significant impact on disease outcome? 34 • How will the clinical trial offer...was 0 041U>< for pat<t!nts NPtS and <H08, 0 4 1ux !01 Ct 110, 1nd 10.0 lux f01 < H13 OJ)Ilo •her on~tion are indiuttd AhtrNtor19 stimuli Wl’f1! pres

  20. Provenance trials of larch in Siberia

    Energy Technology Data Exchange (ETDEWEB)

    Milyutin, L I [V.N. Sukachev Inst. of Forest SB RAS, Krasnoyarsk (Russian Federation)

    1996-12-31

    Some results of provenance trials of larch in Siberia are given. These provenance trials were established in the last thirty years by efforts of V.N. Sukaczev Inst. of Forest. Provenances and species of larch were tested in some field trials distributed over Siberia between Lat. N 52 deg and 66 deg, Long. E 88 deg and 113 deg: near Krasnoyarsk, in Republic Khakasia (an altitudes of 800 and 1200 metres), in the Lower Yenisei near Turukhansk, in the west and south regions of Krasnoyarsk territory, in the Upper Lena, near Chita. 2 refs

  1. [Multicenter randomized trial of amnioinfusion].

    Science.gov (United States)

    Fraser, W; Marcoux, S; Prendiville, W; Petrou, S; Hofmeyr, J; Reinharz, D; Goulet, C; Ohlsson, A

    2000-05-01

    Meconium staining of the amniotic fluid in labor is a frequent problem that is associated with an increase in the risk of neonatal and maternal morbidity. Amnioinfusion is a simple technique that is designed to prevent neonatal and maternal morbidity associated with meconium. Preliminary studies indicate that amnioinfusion is a promising approach to the prevention of such complications of labor. However, further research is required. The primary objective of this multi-centre randomized controlled study is to determine if amnioinfusion for thick meconium stained amniotic fluid results in a reduction in perinatal death or moderate to severe meconium aspiration syndrome. We will also assess the effects of amnioinfusion on other indicators of neonatal morbidity and on cesarean section. The study includes an evaluation of womens views on their childbirth experience and an economic evaluation of a policy of amnioinfusion The study will be achieved with the collaboration of approximately 50 obstetrical centres from across Canada, US, Europe, South America and South Africa. This multicentre trial will provide urgently needed information on the efficacy and effectiveness of amniofusion for the indication of meconium stained amniotic fluid.

  2. A Public Trial De Novo

    DEFF Research Database (Denmark)

    Vedel, Jane Bjørn; Gad, Christopher

    2011-01-01

    This article addresses the concept of “industrial interests” and examines its role in a topical controversy about a large research grant from a private foundation, the Novo Nordisk Foundation, to the University of Copenhagen. The authors suggest that the debate took the form of a “public trial” w.......” The article ends with a discussion of some implications of the analysis, including that policy making, academic research, and public debates might benefit from more detailed accounts of interests and stakes.......This article addresses the concept of “industrial interests” and examines its role in a topical controversy about a large research grant from a private foundation, the Novo Nordisk Foundation, to the University of Copenhagen. The authors suggest that the debate took the form of a “public trial......” where the grant and close(r) intermingling between industry and public research was prosecuted and defended. First, the authors address how the grant was framed in the media. Second, they redescribe the case by introducing new “evidence” that, because of this framing, did not reach “the court...

  3. IAEA monitoring field trials workshop

    International Nuclear Information System (INIS)

    Ross, H.H.; Cooley, J.N.; Belew, W.L.

    1995-01-01

    Recent safeguards inspections in Iraq and elsewhere by the International Atomic Energy Agency (IAEA) have led to the supposition that environmental monitoring can aid in verifying declared and in detecting undeclared nuclear activities or operations. This assumption was most recently examined by the IAEA's Standing Advisory Group on Safeguards Implementation (SAGSI), in their reports to the IAEA Board of Governors. In their reports, SAGSI suggested that further assessment and development of environmental monitoring would be needed to fully evaluate its potential application to enhanced IAEA safeguards. Such an inquiry became part of the IAEA ''Programme 93+2'' assessment of measures to enhance IAEA safeguards. In March, 1994, the International Safeguards Group at Oak Ridge hosted an environmental monitoring field trial workshop for IAEA inspectors to train them in the techniques needed for effective environmental sampling. The workshop included both classroom lectures and actual field sampling exercises. The workshop was designed to emphasize the analytical infrastructure needed for an environmental program, practical sampling methods, and suggested procedures for properly planning a sampling campaign. Detailed techniques for swipe, vegetation, soil, biota, and water associated sampling were covered. The overall approach to the workshop, and observed results, are described

  4. Field trials at Bikini Atoll

    International Nuclear Information System (INIS)

    Robison, William L.; Stone, Earl L.

    1987-01-01

    Last year's report summarized the status of both the long on-going soil and plant sampling programs (initiated by LLNL in 1978) and the field experiments aimed at reducing radionuclide levels in food plants to acceptable levels. In the current report the two are combined into a single summary table, indicating for each field trial or survey the results to date, information expected by the spring of 1988, and projection, if any, for continuation beyond FY1988. This table is therefore a comprehensive survey of the program and accordingly the individual items in it have been coded to facilitate reference to them. Analytical results from field studies installed in 1985 and 1986 are now providing much new information, briefly described below. In part, these results bear out or enlarge the hypotheses that prompted the studies. They also suggest how some treatments may be modified or combined for greater effectiveness. We shall discuss here certain groups of studies of immediate interest that deal with the blocking effects of potassium and other ions on cesium-137 uptake by plants, the effect of removing topsoil (excavation), cultural studies which involve the manipulation of the subsoil, plus some others

  5. Field trials at Bikini Atoll

    Energy Technology Data Exchange (ETDEWEB)

    Robison, William L [Lawrence Livermore National Laboratory, Environmental Sciences Division, Livermore, CA (United States); Stone, Earl L [University of Florida, Soil Science Department, Gainesville, FL (United States)

    1987-07-01

    Last year's report summarized the status of both the long on-going soil and plant sampling programs (initiated by LLNL in 1978) and the field experiments aimed at reducing radionuclide levels in food plants to acceptable levels. In the current report the two are combined into a single summary table, indicating for each field trial or survey the results to date, information expected by the spring of 1988, and projection, if any, for continuation beyond FY1988. This table is therefore a comprehensive survey of the program and accordingly the individual items in it have been coded to facilitate reference to them. Analytical results from field studies installed in 1985 and 1986 are now providing much new information, briefly described below. In part, these results bear out or enlarge the hypotheses that prompted the studies. They also suggest how some treatments may be modified or combined for greater effectiveness. We shall discuss here certain groups of studies of immediate interest that deal with the blocking effects of potassium and other ions on cesium-137 uptake by plants, the effect of removing topsoil (excavation), cultural studies which involve the manipulation of the subsoil, plus some others.

  6. Lucas : kas Juri Lotman koliks tänapäeva Eestisse?

    Index Scriptorium Estoniae

    2009-01-01

    Tallinna Tehnikaülikooli aulas 25. novembril 2009 toimunud konverentsist "Eesti pärast eurot". Konverentsil toimus ka avalik arutelu president Toomas Hendrik Ilvese ja briti ajakirja "The Economist" ajakirjaniku Edward Lucase vahel

  7. Effects of organic food consumption on human health; the jury is still out!

    Science.gov (United States)

    Barański, Marcin; Rempelos, Leonidas; Iversen, Per Ole; Leifert, Carlo

    2017-01-01

    The most recent systematic literature reviews and meta-analyses have indicated significant and nutritionally-relevant composition differences between organic and conventional foods. This included higher antioxidant, but lower cadmium and pesticide levels in organic crops, and higher omega-3 fatty acids concentrations in organic meat and dairy products. Also, results from a small number of human cohort studies indicate that there are positive associations between organic food consumption and reduced risk/incidence of certain acute diseases (e.g. pre-eclampsia, hypospadias) and obesity. Concerns about potential negative health impacts of organic food consumption (e.g. risks linked to lower iodine levels in organic milk) have also been raised, but are not currently supported by evidence from human cohort studies. However, there is virtually no published data from (1) long-term cohort studies focusing on chronic diseases (e.g. cardiovascular disease, diabetes, cancer, and neurodegenerative conditions) and (2) controlled human dietary intervention studies comparing effects of organic and conventional diets. It is therefore currently not possible to quantify to what extent organic food consumption may affect human health.

  8. Social nudging with condorcet juries and its strategic implications for a paternalistic implementation of LED bulbs

    OpenAIRE

    Kalmbach, Bettina

    2016-01-01

    In the light of irrational behaviour and decision biases leading people to commit systematic blunders, Thaler and Sunstein (2003) presented in their approach of libertarian paternalism the concept of choice architecture, to face the problem of wrong decisionmaking and resulting welfare losses by "Nudging" irrational agents. The debate about this approach focuses on its compatibility with libertarian principles, on its welfare-enhancing character and on the knowledge problem about peoples' tru...

  9. The Jury Is Still Out: Psychoemotional Support in Peer E-Mentoring for Transition to University

    Science.gov (United States)

    Risquez, Angelica; Sanchez-Garcia, Marife

    2012-01-01

    This study investigates how computer mediated communication (CMC) can sustain nourishing and emotionally enriching peer mentoring relations. A peer electronic mentoring program was implemented in an Irish university to facilitate freshmen's transition to college. A sample of 123 participants (42 mentors and 81 mentees) was evaluated with a…

  10. Exercise-Induced Muscle Damage and Hypertrophy: A Closer Look Reveals the Jury is Still Out

    OpenAIRE

    Schoenfeld, Brad; Contreras, Bret

    2018-01-01

    This letter is a response to the paper by Damas et al (2017) titled, “The development of skeletal muscle hypertrophy through resistance training: the role of muscle damage and muscle protein synthesis,” which, in part, endeavored to review the role of exercise-induced muscle damage on muscle hypertrophy. We feel there are a number of issues in interpretation of research and extrapolation that preclude drawing the inference expressed in the paper that muscle damage neither explains nor potenti...

  11. Injury prevalence of netball players in South Africa: The need for in jury prevention

    Directory of Open Access Journals (Sweden)

    T. Pillay

    2012-12-01

    Full Text Available This study aimed to establish baseline data for injury prevalence,mechanism of injury, injury severity and management of injuries in netball playersin South Africa. A cross sectional descriptive design was employed to collect databy means of a questionnaire in 2010. Participants consisted of 254 netball playerswho participated in a netball tournament. Permission was obtained from all therelevant organizations and informed consent obtained from the participants. Thegeneral injury rate was 61.8% with an injury rate of 1.9 injuries per player forthe past season. The most commonly injured structures were the ankle 37.5 % andthe knee 28.6% with the most common mechanism of injury being landing, 19% and 29% respectively. Of those whosustained injuries, 86 (44% of the injured athletes’ sustained severe injuries, 31(16% sustained moderate injuriesand 78 (40% sustained mild injuries. 67% of players reported they were able to continue with the game and 33%received medical assistance losing game and training time. The most common form of management accessed wasphysiotherapy, which accounted for 31%. It is evident that the ankle and knee injury rates amongst South Africannetball players are high in comparison to other netball playing nations. Injury surveillance is an integral part ofdeveloping preventative measures. The article lays a platform for developing these strategies against the backdrop ofits findings and comparison with other authors.

  12. Rooting the tree of life: the phylogenetic jury is still out.

    Science.gov (United States)

    Gouy, Richard; Baurain, Denis; Philippe, Hervé

    2015-09-26

    This article aims to shed light on difficulties in rooting the tree of life (ToL) and to explore the (sociological) reasons underlying the limited interest in accurately addressing this fundamental issue. First, we briefly review the difficulties plaguing phylogenetic inference and the ways to improve the modelling of the substitution process, which is highly heterogeneous, both across sites and over time. We further observe that enriched taxon samplings, better gene samplings and clever data removal strategies have led to numerous revisions of the ToL, and that these improved shallow phylogenies nearly always relocate simple organisms higher in the ToL provided that long-branch attraction artefacts are kept at bay. Then, we note that, despite the flood of genomic data available since 2000, there has been a surprisingly low interest in inferring the root of the ToL. Furthermore, the rare studies dealing with this question were almost always based on methods dating from the 1990s that have been shown to be inaccurate for much more shallow issues! This leads us to argue that the current consensus about a bacterial root for the ToL can be traced back to the prejudice of Aristotle's Great Chain of Beings, in which simple organisms are ancestors of more complex life forms. Finally, we demonstrate that even the best models cannot yet handle the complexity of the evolutionary process encountered both at shallow depth, when the outgroup is too distant, and at the level of the inter-domain relationships. Altogether, we conclude that the commonly accepted bacterial root is still unproven and that the root of the ToL should be revisited using phylogenomic supermatrices to ensure that new evidence for eukaryogenesis, such as the recently described Lokiarcheota, is interpreted in a sound phylogenetic framework. © 2015 The Author(s).

  13. Zika mosquito vectors: the jury is still out [version 1; referees: 5 approved

    Directory of Open Access Journals (Sweden)

    Walter S. Leal

    2016-10-01

    Full Text Available After a 40-year hiatus, the International Congress of Entomology (ICE 2016 convened in Orlando, Florida (September 25-30, 2016. One of the symposia at ICE 2016, the Zika Symposium, covered multiple aspects of the Zika epidemic, including epidemiology, sexual transmission, genetic tools for reducing transmission, and particularly vector competence. While there was a consensus among participants that the yellow fever mosquito, Aedes aegypti, is a vector of the Zika virus, there is growing evidence indicating that the range of mosquito vectors might be wider than anticipated. In particular, three independent groups from Canada, China, and Brazil presented and discussed laboratory and field data strongly suggesting that the southern house mosquito, Culex quinquefasciatus, also known as the common mosquito, is highly likely to be a vector in certain environments.

  14. Zika mosquito vectors: the jury is still out [version 2; referees: 5 approved

    Directory of Open Access Journals (Sweden)

    Walter S. Leal

    2016-11-01

    Full Text Available After a 40-year hiatus, the International Congress of Entomology (ICE 2016 convened in Orlando, Florida (September 25-30, 2016. One of the symposia at ICE 2016, the Zika Symposium, covered multiple aspects of the Zika epidemic, including epidemiology, sexual transmission, genetic tools for reducing transmission, and particularly vector competence. While there was a consensus among participants that the yellow fever mosquito, Aedes aegypti, is a vector of the Zika virus, there is growing evidence indicating that the range of mosquito vectors might be wider than anticipated. In particular, three independent groups from Canada, China, and Brazil presented and discussed laboratory and field data strongly suggesting that the southern house mosquito, Culex quinquefasciatus, also known as the common mosquito, is highly likely to be a vector in certain environments.

  15. Change over Time in Obedience: The Jury's Still out, but It Might Be Decreasing

    Science.gov (United States)

    Twenge, Jean M.

    2009-01-01

    Jerry M. Burger's (see record 2008-19206-001) partial replication of Stanley Milgram's (1974) obedience study shows both the influence of culture and generations on behavior and the power of the situation. In Burger's data, disobedience has nearly doubled among male participants since the 1960s, a shift just as large as the increase in Americans'…

  16. The annual cycle of African climate and its variability | Jury | Water SA

    African Journals Online (AJOL)

    low) annual cycle correspond with La Nina (El Nino) and increased (decreased) inter-annual fluctuations of the African climate. A composite analysis shows that the South Atlantic Hadley cell and standing waves in the subtropical jet may connect ...

  17. Applying the Capital Jury Project Findings to Court-Martial Practice

    Science.gov (United States)

    2010-06-11

    Hollywood portrayals to shape our understanding of what happens inside the deliberation room.1 For example, in the movie 12 Angry Men,2 an 18-year old...we see in courts-martial for sexual assaults, where a tough merits case leads to a guilty finding, but the sentence is too light, in a normative...protect the stability and finality of verdicts, protect panel members from harassment and embarrassment, and to prevent unlawful command influence

  18. Fostering Organizational Change through Deliberations: The Deliberative Jury in a University Setting

    Science.gov (United States)

    Lindell, Juha

    2014-01-01

    Universities in Europe face a variety of reform initiatives, and university reform can be seen as a wicked problem that should be resolved through collaborative efforts. In Finland, there has been considerable resistance to proposed reforms, with university personnel complaining that they have not been heard. Students, on the other hand, seem…

  19. Jon Elster's Securities against Misrule: Juries, Assemblies, Elections: A Review Essay

    OpenAIRE

    David Austen-Smith

    2015-01-01

    The standard economic approach to designing institutions for collective decision making recognizes individuals' strategically rational motivations for misrepresentation and asks how best, given an objective function, to design a set of incentives and constraints to internalize or negate such motivations. Securities Against Misrule offers, in the author's phrase, an "essay in persuasion" to the effect that such an approach is fundamentally misguided. Instead, Elster argues for a behavioral app...

  20. Carbon Sequestration by Perennial Energy Crops: Is the Jury Still Out?

    Science.gov (United States)

    Agostini, Francesco; Gregory, Andrew S; Richter, Goetz M

    Soil organic carbon (SOC) changes associated with land conversion to energy crops are central to the debate on bioenergy and their potential carbon neutrality. Here, the experimental evidence on SOC under perennial energy crops (PECs) is synthesised to parameterise a whole systems model and to identify uncertainties and knowledge gaps determining PECs being a sink or source of greenhouse gas (GHG). For Miscanthus and willow ( Salix spp.) and their analogues (switchgrass, poplar), we examine carbon (C) allocation to above- and belowground residue inputs, turnover rates and retention in the soil. A meta-analysis showed that studies on dry matter partitioning and C inputs to soils are plentiful, whilst data on turnover are rare and rely on few isotopic C tracer studies. Comprehensive studies on SOC dynamics and GHG emissions under PECs are limited and subsoil processes and C losses through leaching remain unknown. Data showed dynamic changes of gross C inputs and SOC stocks depending on stand age. C inputs and turnover can now be specifically parameterised in whole PEC system models, whilst dependencies on soil texture, moisture and temperature remain empirical. In conclusion, the annual net SOC storage change exceeds the minimum mitigation requirement (0.25 Mg C ha -1 year -1 ) under herbaceous and woody perennials by far (1.14 to 1.88 and 0.63 to 0.72 Mg C ha -1 year -1 , respectively). However, long-term time series of field data are needed to verify sustainable SOC enrichment, as the physical and chemical stabilities of SOC pools remain uncertain, although they are essential in defining the sustainability of C sequestration (half-life >25 years).

  1. Brachiopodové fauny triasu a jury v oblasti Salzkammergut v Rakousku

    Czech Academy of Sciences Publication Activity Database

    Siblík, Miloš

    2007-01-01

    Roč. 2006, - (2007), s. 166-167 ISSN 0514-8057 Institutional research plan: CEZ:AV0Z30130516 Keywords : brachiopods * Triassic * Jurassic Subject RIV: EG - Zoology http://www.geology.cz/zpravy/obsah/2006/2006-str.166-167.pdf

  2. How to keep existing customers and get new ones? / Juris Ozols

    Index Scriptorium Estoniae

    Ozols, Juris

    2004-01-01

    Autor selgitab rahulolevate ja lojaalsete klientide peamisi erinevusi, tutvustab klientide lojaalsuse ja pühendumuse hindamise metoodikat ning selgitab, milles seisneb kliendiuuringu läbiviimisest tulenev otsene kasu ettevõtte jaoks. Diagramm

  3. Preliminary evaluation of factors associated with premature trial closure and feasibility of accrual benchmarks in phase III oncology trials.

    Science.gov (United States)

    Schroen, Anneke T; Petroni, Gina R; Wang, Hongkun; Gray, Robert; Wang, Xiaofei F; Cronin, Walter; Sargent, Daniel J; Benedetti, Jacqueline; Wickerham, Donald L; Djulbegovic, Benjamin; Slingluff, Craig L

    2010-08-01

    A major challenge for randomized phase III oncology trials is the frequent low rates of patient enrollment, resulting in high rates of premature closure due to insufficient accrual. We conducted a pilot study to determine the extent of trial closure due to poor accrual, feasibility of identifying trial factors associated with sufficient accrual, impact of redesign strategies on trial accrual, and accrual benchmarks designating high failure risk in the clinical trials cooperative group (CTCG) setting. A subset of phase III trials opened by five CTCGs between August 1991 and March 2004 was evaluated. Design elements, experimental agents, redesign strategies, and pretrial accrual assessment supporting accrual predictions were abstracted from CTCG documents. Percent actual/predicted accrual rate averaged per month was calculated. Trials were categorized as having sufficient or insufficient accrual based on reason for trial termination. Analyses included univariate and bivariate summaries to identify potential trial factors associated with accrual sufficiency. Among 40 trials from one CTCG, 21 (52.5%) trials closed due to insufficient accrual. In 82 trials from five CTCGs, therapeutic trials accrued sufficiently more often than nontherapeutic trials (59% vs 27%, p = 0.05). Trials including pretrial accrual assessment more often achieved sufficient accrual than those without (67% vs 47%, p = 0.08). Fewer exclusion criteria, shorter consent forms, other CTCG participation, and trial design simplicity were not associated with achieving sufficient accrual. Trials accruing at a rate much lower than predicted (accrual rate) were consistently closed due to insufficient accrual. This trial subset under-represents certain experimental modalities. Data sources do not allow accounting for all factors potentially related to accrual success. Trial closure due to insufficient accrual is common. Certain trial design factors appear associated with attaining sufficient accrual. Defining

  4. Patient engagement in clinical trials: The Clinical Trials Transformation Initiative's leadership from theory to practical implementation.

    Science.gov (United States)

    Patrick-Lake, Bray

    2018-02-01

    Patient engagement is an increasingly important aspect of successful clinical trials. Over the past decade, as patient group involvement in clinical trials has continued to increase and diversify, the Clinical Trials Transformation Initiative has not only recognized the crucial role patients play in improving the clinical trial enterprise but also made a deep commitment to help grow and shape the emerging field of patient engagement. This article describes the evolution of patient engagement including the origins of the patient engagement movement; barriers to successful engagement and remaining challenges to full and valuable collaboration between patient groups and trial sponsors; and Clinical Trials Transformation Initiative's role in influencing the field through organizational practices, formal project work and resulting recommendations, and external advocacy efforts.

  5. Clinical trial data analysis using R

    National Research Council Canada - National Science Library

    Chen, Ding-Geng; Peace, Karl E

    2011-01-01

    .... Case studies demonstrate how to select the appropriate clinical trial data. The authors introduce the corresponding biostatistical analysis methods, followed by the step-by-step data analysis using R...

  6. Narrating the Mensalão trial

    DEFF Research Database (Denmark)

    Damgaard, Mads

    2015-01-01

    Coming to a close in the last days of 2012, the trial of the so-called mensalão network was heralded as Brazil's trial of the century. Involving corruption in the top ranks of the business world and the former government, the process ended with an exceptional result in the sense that severe...... sentences were meted out to 25 of the 38 defendants, thereby breaking an established pattern of impunity for corrupt politicians in Brazilian courts. As a scandal potentially harmful for the governing party and the former president Luis “Lula” da Silva, the eyes and spotlights of the national media were...... fixed on the trial. However, the varying and contested ways in which the case was presented by media from the outbreak of the scandal in 2005 until the end of the trial bears witness to the fact that narratives concerning corruption scandals can potentially encompass a broad range of political...

  7. NIH Clinical Research Trials and You

    Science.gov (United States)

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

  8. Citicoline for ischemic stroke: ICTUS trial

    Directory of Open Access Journals (Sweden)

    Vladimir Anatolyevich Parfenov

    2012-01-01

    Full Text Available The paper gives data available in the literature on the use of citicoline in an experimental model of ischemic stroke (IS and in randomized multicenter placebo-controlled trials. It analyzes the results of the ICTUS trial in which 2298 patients with IS who received randomly citicoline or placebo for 24 hours after the onset of symptoms (I000 mg intravenously every I2 hours during the first 3 days, then orally as one 500-mg tablet every 12 hours during 6 weeks. The results of the trial confirmed the safety of citicoline used in IS, but failed to show its significant advantage over placebo in reducing the degree of disability (global improvement 90 days later. However, to pool the results of the ICTUS trial with those of other randomized multicenter placebo-controlled studies demonstrates a significant decrease in the degree of disability in IS patients treated with citicoline.

  9. Soil stabilization field trial : interim report II.

    Science.gov (United States)

    2002-02-01

    Shrinkage cracks in cement-stabilized bases/subbase can be alleviated by specifying the right cement dosage, or by other additives/procedures that suppress crack susceptibility. A field trial of six 1000 ft sections to investigate several alternative...

  10. Involving South Asian patients in clinical trials.

    Science.gov (United States)

    Hussain-Gambles, M; Leese, B; Atkin, K; Brown, J; Mason, S; Tovey, P

    2004-10-01

    To investigate how South Asian patients conceptualise the notion of clinical trials and to identify key processes that impact on trial participation and the extent to which communication difficulties, perceptions of risk and attitudes to authority influence these decisions. Also to identify whether 'South Asian' patients are homogeneous in these issues, and which factors differ between different South Asian subgroups and finally how professionals regard the involvement of South Asian patients and their views on strategies to increase participation. A review of the literature on minority ethnic participation in clinical trials was followed by three qualitative interview studies. Interviews were taped and transcribed (and translated if required) and subjected to framework analysis. Face-to-face interviews were conducted with 25 health professionals; 60 South Asian lay people who had not taken part in a trial and 15 South Asian trial participants. Motivations for trial participation were identified as follows: to help society, to improve own health or that of family and friends, out of obligation to the doctor and to increase scientific knowledge. Deterrents were concerns about drug side-effects, busy lifestyles, language, previous bad experiences, mistrust and feelings of not belonging to British society. There was no evidence of antipathy amongst South Asians to the concept of clinical trials and, overall, the younger respondents were more knowledgeable than the older ones. Problems are more likely to be associated with service delivery. Lack of being approached was a common response. Lay-reported factors that might affect South Asian participation in clinical trials include age, language, social class, feeling of not belonging/mistrust, culture and religion. Awareness of clinical trials varied between each group. There are more similarities than differences in attitudes towards clinical trial participation between the South Asian and the general population

  11. Overcoming Age Limits in Cancer Clinical Trials

    Science.gov (United States)

    Adolescents, young adults, and the elderly lag far behind other age groups when it comes to enrolling in clinical trials. Their participation is critical to advancing effective therapies for these age groups.

  12. Blinding in randomized clinical trials: imposed impartiality

    DEFF Research Database (Denmark)

    Hróbjartsson, A; Boutron, I

    2011-01-01

    Blinding, or "masking," is a crucial method for reducing bias in randomized clinical trials. In this paper, we review important methodological aspects of blinding, emphasizing terminology, reporting, bias mechanisms, empirical evidence, and the risk of unblinding. Theoretical considerations...

  13. Judicial Functions in the Criminal Trial

    Directory of Open Access Journals (Sweden)

    Constantin Tănase

    2014-05-01

    Full Text Available The separation of judicial functions falls, indisputably, in the news gallery of the Romanian criminal trial current rules. The previous Criminal Procedure Code, namely that of 1968, as well as the older ones, hadn‟t enrolled in their content such a principle. However, the doctrine identified, under mentioned legal regulations, the existence of distinct procedural functions and their need to separate, in the idea of genuine criminal justice accomplishment. These procedural functions were: the indictment function (or charges, the defense function the trial function. In the new code, this principle proclaims the existence of four judicial functions that aim the efficiency and speed of the criminal trial, but also guarantee the presumption of innocence, equal opportunity of parties, protection of rights and fundamental freedoms. This research try to explain this principle and its connections with other institutions of the criminal trial.

  14. The PACT trial: PAtient Centered Telerehabilitation

    Directory of Open Access Journals (Sweden)

    Andreas Stefan Rothgangel

    2015-01-01

    Discussion: Several questions concerning the study design that emerged during the preparation of this trial will be discussed. This will include how these questions were addressed and arguments for the choices that were made.

  15. ORIGINAL ARTICLES Pharmacologically active: clinical trials and ...

    African Journals Online (AJOL)

    2008-01-22

    Jan 22, 2008 ... The US database, on the other hand, clearly identifies 172 ... operating within extended clinical trials R&D value chains. Companies often ... Source: CeSTII Survey Management and Results System internal database. Table III.

  16. randomised trial of alternative malaria chemoprophylaxis strategies

    African Journals Online (AJOL)

    hi-tech

    2000-02-02

    Feb 2, 2000 ... randomisation produced comparable intervention and comparison groups with balanced characteristics. Specific results of the baseline studies are presented in the companion paper. ... strategies for protecting pregnant women against malaria. ..... from malaria vaccine trial conducted among Tanzanian.

  17. Best clinical trials reported in 2010.

    Science.gov (United States)

    Garner, John B; Grayburn, Paul A; Yancy, Clyde W

    2011-07-01

    Each year, a number of clinical trials emerge with data sufficient to change clinical practice. Determining which findings will result in practice change and which will provide only incremental benefit can be a dilemma for clinicians. The authors review selected clinical trials reported in 2010 in journals, at society meetings, and at conferences, focusing on those studies that have the potential to change clinical practice. This review offers 3 separate means of analysis: an abbreviated text summary, organized by subject area; a comprehensive table of relevant clinical trials that provides a schematic review of the hypotheses, interventions, methods, primary end points, results, and implications; and a complete bibliography for further reading as warranted. It is hoped that this compilation of relevant clinical trials and their important findings released in 2010 will be of benefit in the everyday practice of cardiovascular medicine. Copyright © 2011 Elsevier Inc. All rights reserved.

  18. Marketing and clinical trials: a case study

    OpenAIRE

    Entwistle Vikki A; Snowdon Claire; Garcia Jo; Knight Rosemary C; Shakur Haleema; Elbourne Diana R; Roberts Ian; Francis David; McDonald Alison M; Grant Adrian M; Campbell Marion K

    2007-01-01

    Abstract Background Publicly funded clinical trials require a substantial commitment of time and money. To ensure that sufficient numbers of patients are recruited it is essential that they address important questions in a rigorous manner and are managed well, adopting effective marketing strategies. Methods Using methods of analysis drawn from management studies, this paper presents a structured assessment framework or reference model, derived from a case analysis of the MRC's CRASH trial, o...

  19. Strength of Mock-up Trial Grout

    DEFF Research Database (Denmark)

    Sørensen, Eigil V.

    The present report describes tests carried out on samples taken and cast during the execution of a mock-up trial placement of the high performance grout MASTERFLOW 9500 on January 21, 2009.......The present report describes tests carried out on samples taken and cast during the execution of a mock-up trial placement of the high performance grout MASTERFLOW 9500 on January 21, 2009....

  20. Linking ClinicalTrials.gov and PubMed to track results of interventional human clinical trials.

    Directory of Open Access Journals (Sweden)

    Vojtech Huser

    Full Text Available OBJECTIVE: In an effort to understand how results of human clinical trials are made public, we analyze a large set of clinical trials registered at ClinicalTrials.gov, the world's largest clinical trial registry. MATERIALS AND METHODS: We considered two trial result artifacts: (1 existence of a trial result journal article that is formally linked to a registered trial or (2 the deposition of a trial's basic summary results within the registry. RESULTS: The study sample consisted of 8907 completed, interventional, phase 2-or-higher clinical trials that were completed in 2006-2009. The majority of trials (72.2% had no structured trial-article link present. A total of 2367 trials (26.6% deposited basic summary results within the registry. Of those, 969 trials (10.9% were classified as trials with extended results and 1398 trials (15.7% were classified as trials with only required basic results. The majority of the trials (54.8% had no evidence of results, based on either linked result articles or basic summary results (silent trials, while a minimal number (9.2% report results through both registry deposition and publication. DISCUSSION: Our study analyzes the body of linked knowledge around clinical trials (which we refer to as the "trialome". Our results show that most trials do not report results and, for those that do, there is minimal overlap in the types of reporting. We identify several mechanisms by which the linkages between trials and their published results can be increased. CONCLUSION: Our study shows that even when combining publications and registry results, and despite availability of several information channels, trial sponsors do not sufficiently meet the mandate to inform the public either via a linked result publication or basic results submission.

  1. Inclusion of Minority Patients in Breast Cancer Clinical Trials: The Role of the Clinical Trial Environment

    National Research Council Canada - National Science Library

    Kaplan, Celia P

    2007-01-01

    .... While inroads to increasing minority inclusion in breast cancer clinical trials have been made, recent reports continue to demonstrate lower enrollment among African Americans, Asian Americans...

  2. Qualitative research within trials: developing a standard operating procedure for a clinical trials unit

    Science.gov (United States)

    2013-01-01

    Background Qualitative research methods are increasingly used within clinical trials to address broader research questions than can be addressed by quantitative methods alone. These methods enable health professionals, service users, and other stakeholders to contribute their views and experiences to evaluation of healthcare treatments, interventions, or policies, and influence the design of trials. Qualitative data often contribute information that is better able to reform policy or influence design. Methods Health services researchers, including trialists, clinicians, and qualitative researchers, worked collaboratively to develop a comprehensive portfolio of standard operating procedures (SOPs) for the West Wales Organisation for Rigorous Trials in Health (WWORTH), a clinical trials unit (CTU) at Swansea University, which has recently achieved registration with the UK Clinical Research Collaboration (UKCRC). Although the UKCRC requires a total of 25 SOPs from registered CTUs, WWORTH chose to add an additional qualitative-methods SOP (QM-SOP). Results The qualitative methods SOP (QM-SOP) defines good practice in designing and implementing qualitative components of trials, while allowing flexibility of approach and method. Its basic principles are that: qualitative researchers should be contributors from the start of trials with qualitative potential; the qualitative component should have clear aims; and the main study publication should report on the qualitative component. Conclusions We recommend that CTUs consider developing a QM-SOP to enhance the conduct of quantitative trials by adding qualitative data and analysis. We judge that this improves the value of quantitative trials, and contributes to the future development of multi-method trials. PMID:23433341

  3. Improved Endpoints for Cancer Immunotherapy Trials

    Science.gov (United States)

    Eggermont, Alexander M. M.; Janetzki, Sylvia; Hodi, F. Stephen; Ibrahim, Ramy; Anderson, Aparna; Humphrey, Rachel; Blumenstein, Brent; Wolchok, Jedd

    2010-01-01

    Unlike chemotherapy, which acts directly on the tumor, cancer immunotherapies exert their effects on the immune system and demonstrate new kinetics that involve building a cellular immune response, followed by changes in tumor burden or patient survival. Thus, adequate design and evaluation of some immunotherapy clinical trials require a new development paradigm that includes reconsideration of established endpoints. Between 2004 and 2009, several initiatives facilitated by the Cancer Immunotherapy Consortium of the Cancer Research Institute and partner organizations systematically evaluated an immunotherapy-focused clinical development paradigm and created the principles for redefining trial endpoints. On this basis, a body of clinical and laboratory data was generated that supports three novel endpoint recommendations. First, cellular immune response assays generate highly variable results. Assay harmonization in multicenter trials may minimize variability and help to establish cellular immune response as a reproducible biomarker, thus allowing investigation of its relationship with clinical outcomes. Second, immunotherapy may induce novel patterns of antitumor response not captured by Response Evaluation Criteria in Solid Tumors or World Health Organization criteria. New immune-related response criteria were defined to more comprehensively capture all response patterns. Third, delayed separation of Kaplan–Meier curves in randomized immunotherapy trials can affect results. Altered statistical models describing hazard ratios as a function of time and recognizing differences before and after separation of curves may allow improved planning of phase III trials. These recommendations may improve our tools for cancer immunotherapy trials and may offer a more realistic and useful model for clinical investigation. PMID:20826737

  4. New approaches to trials in glomerulonephritis.

    Science.gov (United States)

    Craig, Jonathan C; Tong, Allison; Strippoli, Giovanni F M

    2017-01-01

    Randomized controlled trials are required to reliably identify interventions to improve the outcomes for people with glomerulonephritis (GN). Unfortunately, although easier, observational studies are inherently unreliable even though the findings of both study designs agree most of the time. Currently there are ∼790 trials in GN, but suboptimal design and reporting, together with small sample sizes, mean that they may not be reliable for decision making. If the history is somewhat bleak, the future looks bright, with recent initiatives to improve the quality, size and relevance of clinical trials in nephrology, including greater patient engagement, trial networks, core outcome sets, registry-based trials and adaptive designs. Given the current state of the evidence informing the care of people with GN, disruptive technologies and pervasive culture change is required to ensure that the potential of trials to improve the health of people with this complex condition is to be realized. © The Author 2017. Published by Oxford University Press on behalf of ERA-EDTA. All rights reserved.

  5. Talking About Trials: Overcoming Bottlenecks in Clinical Communication

    Science.gov (United States)

    Participation in clinical trials by adult patients is dismally low. No one knows how many patients are offered the opportunity to enroll in trials. NCI researchers are studying how patients hear about trials, whether they discuss enrollment with their providers, and the roles they play in deciding to participate in a trial.

  6. 21 CFR 886.1415 - Ophthalmic trial lens frame.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Ophthalmic trial lens frame. 886.1415 Section 886...) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1415 Ophthalmic trial lens frame. (a) Identification. An opthalmic trial lens frame is a mechanical device intended to hold trial lenses for vision...

  7. Trial-Based Thought Record (TBTR: preliminary data on a strategy to deal with core beliefs by combining sentence reversion and the use of analogy with a judicial process Registro de Pensamentos com Base no Processo (RPBP: dados preliminares de uma estratégia para lidar com crenças nucleares, combinando reversão de sentenças e analogia com o processo jurídico

    Directory of Open Access Journals (Sweden)

    Irismar Reis de Oliveira

    2008-03-01

    Full Text Available OBJECTIVE: To propose the Trial-Based Thought Record, a modified, 7-column thought record addressing core beliefs by sentence reversion and the analogy to a trial. METHOD: Clients (n = 30 participated in a simulation of a trial and exhibited shifts in their adherence to core beliefs and in the intensity of corresponding emotions after each step (investigation, prosecutor’ s plea, defense attorney’ s plea, prosecutor’ s second plea, defense attorney’ s second plea, and jury verdict during a session. RESULTS: Significant mean reductions existed between percent values after investigation (taken as baseline and defense attorney’ s plea (p OBJETIVO: Propor o Registro de Pensamentos com Base no Processo, versão modificada, com sete colunas, para lidar com as crenças nucleares por meio da combinação da reversão de sentenças e a analogia com um processo jurídico. MÉTODO: Os clientes (n = 30 participaram da simulação de um júri e exibiram mudanças na adesão às crenças nucleares e na intensidade das emoções correspondentes após cada passo durante uma sessão (investigação, alegação do promotor, alegação do advogado de defesa, réplica do promotor, tréplica do advogado de defesa e veredicto do júri. RESULTADOS: Reduções médias significantes foram observadas entre os valores percentuais após a investigação (tomada como valor basal, a alegação da defesa (p < 0,001 e o veredicto do júri, tanto das crenças (p < 0,001 quanto da intensidade das emoções (p < 0,001. Diferenças significantes foram também observadas entre as primeira e segunda alegações da defesa (p = 0,009 e entre a segunda alegação da defesa e o veredicto do júri no que diz respeito às crenças nucleares (p = 0,005 e às emoções (p = 0,02. CONCLUSÃO: O Registro de Pensamentos com Base no Processo pode, pelo menos temporariamente, ajudar os pacientes, de forma construtiva, a reduzirem a adesão às crenças nucleares negativas e emo

  8. UK Dermatology Clinical Trials Network’s STOP GAP trial (a multicentre trial of prednisolone versus ciclosporin for pyoderma gangrenosum: protocol for a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Craig Fiona F

    2012-04-01

    Full Text Available Abstract Background Pyoderma gangrenosum (PG is a rare inflammatory skin disorder characterised by painful and rapidly progressing skin ulceration. PG can be extremely difficult to treat and patients often require systemic immunosuppression. Recurrent lesions of PG are common, but the relative rarity of this condition means that there is a lack of published evidence regarding its treatment. A systematic review published in 2005 found no randomised controlled trials (RCTs relating to the treatment of PG. Since this time, one small RCT has been published comparing infliximab to placebo, but none of the commonly used systemic treatments for PG have been formally assessed. The UK Dermatology Clinical Trials Network’s STOP GAP Trial has been designed to address this lack of trial evidence. Methods The objective is to assess whether oral ciclosporin is more effective than oral prednisolone for the treatment of PG. The trial design is a two-arm, observer-blind, parallel-group, randomised controlled trial comparing ciclosporin (4 mg/kg/day to prednisolone (0.75 mg/kg/day. A total of 140 participants are to be recruited over a period of 4 years, from up to 50 hospitals in the UK and Eire. Primary outcome of velocity of healing at 6 weeks is assessed blinded to treatment allocation (using digital images of the ulcers. Secondary outcomes include: (i time to healing; (ii global assessment of improvement; (iii PG inflammation assessment scale score; (iv self-reported pain; (v health-related quality of life; (vi time to recurrence; (vii treatment failures; (viii adverse reactions to study medications; and (ix cost effectiveness/utility. Patients with a clinical diagnosis of PG (excluding granulomatous PG; measurable ulceration (that is, not pustular PG; and patients aged over 18 years old who are able to give informed consent are included in the trial. Randomisation is by computer generated code using permuted blocks of randomly varying size

  9. Portfolio of prospective clinical trials including brachytherapy: an analysis of the ClinicalTrials.gov database.

    Science.gov (United States)

    Cihoric, Nikola; Tsikkinis, Alexandros; Miguelez, Cristina Gutierrez; Strnad, Vratislav; Soldatovic, Ivan; Ghadjar, Pirus; Jeremic, Branislav; Dal Pra, Alan; Aebersold, Daniel M; Lössl, Kristina

    2016-03-22

    To evaluate the current status of prospective interventional clinical trials that includes brachytherapy (BT) procedures. The records of 175,538 (100 %) clinical trials registered at ClinicalTrials.gov were downloaded on September 2014 and a database was established. Trials using BT as an intervention were identified for further analyses. The selected trials were manually categorized according to indication(s), BT source, applied dose rate, primary sponsor type, location, protocol initiator and funding source. We analyzed trials across 8 available trial protocol elements registered within the database. In total 245 clinical trials were identified, 147 with BT as primary investigated treatment modality and 98 that included BT as an optional treatment component or as part of the standard treatment. Academic centers were the most frequent protocol initiators in trials where BT was the primary investigational treatment modality (p < 0.01). High dose rate (HDR) BT was the most frequently investigated type of BT dose rate (46.3 %) followed by low dose rate (LDR) (42.0 %). Prostate was the most frequently investigated tumor entity in trials with BT as the primary treatment modality (40.1 %) followed by breast cancer (17.0 %). BT was rarely the primary investigated treatment modality for cervical cancer (6.8 %). Most clinical trials using BT are predominantly in early phases, investigator-initiated and with low accrual numbers. Current investigational activities that include BT mainly focus on prostate and breast cancers. Important questions concerning the optimal usage of BT will not be answered in the near future.

  10. Study of the trial subjects’ protection aspects in Phase I clinical trials and bioequivalence studies

    Directory of Open Access Journals (Sweden)

    K. O. Zupanets

    2016-03-01

    Full Text Available Protection of rights, health and well-being of persons who are taking the drug during the trial (trial subjects is one of the basic principles of clinical trials (CT management. Aim. In order to study key aspects of volunteer protection, determine factors that influence these indicators and estimate the importance of ensuring their proper implementation on the clinical site (CS three survey of 135 trial subjects were carried out to evaluate the importance of assessing the impact of factors such as the procedure of signing the informed consent (IC at the CS and testing procedures for HIV / AIDS, hepatitis and others. Assessment of the quality of life of trial subjects as indirect indicator of the quality of clinical trials that ensures the proper protection of their life was the subject of the third survey. Methods and results. The general model of the relationship between the key aspects of the trial subjects protection and the factors which are providing them during the clinical trials of drugs management was substantiated, which included the main aspects of the trial subjects’ protection, protective factors and basic CT management procedures, the impact of the above factors on the possibility of providing protection aspects depends on their implementation quality. It was found that trial subjects’ protection improvement can be achieved during the IC signing process. It is necessary to ensure a higher level of volunteers understanding of the terms that could be used in the IC form. Regarding the procedure of compulsory testing for HIV/AIDS in the course of screening, we can conclude that the majority of the trial subjects believe that this procedure is an additional factor in their health protection and do not consider it as an excessive psychological pressure on them. Conclusion. Assessing the quality of life during the bioequivalence study at the CS makes possible to reach a conclusion on general well-being and satisfaction with those

  11. An analysis of registered clinical trials in otolaryngology from 2007 to 2010: ClinicalTrials.gov.

    Science.gov (United States)

    Witsell, David L; Schulz, Kristine A; Lee, Walter T; Chiswell, Karen

    2013-11-01

    To describe the conditions studied, interventions used, study characteristics, and funding sources of otolaryngology clinical trials from the ClinicalTrials.gov database; compare this otolaryngology cohort of interventional studies to clinical visits in a health care system; and assess agreement between clinical trials and clinical activity. Database analysis. Trial registration data downloaded from ClinicalTrials.gov and administrative data from the Duke University Medical Center from October 1, 2007 to September 27, 2010. Data extraction from ClinicalTrials.gov was done using MeSH and non-MeSH disease condition terms. Studies were subcategorized to create the following groupings for descriptive analysis: ear, nose, allergy, voice, sleep, head and neck cancer, thyroid, and throat. Duke Health System visits were queried by using selected ICD-9 codes for otolaryngology and non-otolaryngology providers. Visits were grouped similarly to ClinicalTrials.gov for further analysis. Chi-square tests were used to explore differences between groups. A total of 1115 of 40,970 registered interventional trials were assigned to otolaryngology. Head and neck cancer trials predominated. Study models most frequently incorporated parallel design (54.6%), 2 study groups (46.6%), and randomization (69.1%). Phase 2 or 3 studies constituted 46.4% of the cohort. Comparison of the ClinicalTrials.gov database with administrative health system visit data by disease condition showed discordance between national research activity and clinical visit volume for patients with otolaryngology complaints. Analysis of otolaryngology-related clinical research as listed in ClinicalTrials.gov can inform patients, physicians, and policy makers about research focus areas. The relative burden of otolaryngology-associated conditions in our tertiary health system exceeds research activity within the field.

  12. Portfolio of prospective clinical trials including brachytherapy: an analysis of the ClinicalTrials.gov database

    International Nuclear Information System (INIS)

    Cihoric, Nikola; Tsikkinis, Alexandros; Miguelez, Cristina Gutierrez; Strnad, Vratislav; Soldatovic, Ivan; Ghadjar, Pirus; Jeremic, Branislav; Dal Pra, Alan; Aebersold, Daniel M.; Lössl, Kristina

    2016-01-01

    To evaluate the current status of prospective interventional clinical trials that includes brachytherapy (BT) procedures. The records of 175,538 (100 %) clinical trials registered at ClinicalTrials.gov were downloaded on September 2014 and a database was established. Trials using BT as an intervention were identified for further analyses. The selected trials were manually categorized according to indication(s), BT source, applied dose rate, primary sponsor type, location, protocol initiator and funding source. We analyzed trials across 8 available trial protocol elements registered within the database. In total 245 clinical trials were identified, 147 with BT as primary investigated treatment modality and 98 that included BT as an optional treatment component or as part of the standard treatment. Academic centers were the most frequent protocol initiators in trials where BT was the primary investigational treatment modality (p < 0.01). High dose rate (HDR) BT was the most frequently investigated type of BT dose rate (46.3 %) followed by low dose rate (LDR) (42.0 %). Prostate was the most frequently investigated tumor entity in trials with BT as the primary treatment modality (40.1 %) followed by breast cancer (17.0 %). BT was rarely the primary investigated treatment modality for cervical cancer (6.8 %). Most clinical trials using BT are predominantly in early phases, investigator-initiated and with low accrual numbers. Current investigational activities that include BT mainly focus on prostate and breast cancers. Important questions concerning the optimal usage of BT will not be answered in the near future. The online version of this article (doi:10.1186/s13014-016-0624-8) contains supplementary material, which is available to authorized users

  13. Likely country of origin in publications on randomised controlled trials and controlled clinical trials during the last 60 years

    DEFF Research Database (Denmark)

    Gluud, Christian; Nikolova, Dimitrinka

    2007-01-01

    The number of publications on clinical trials is unknown as well as the countries publishing most trial reports. To try to examine these questions we performed an ecological study.......The number of publications on clinical trials is unknown as well as the countries publishing most trial reports. To try to examine these questions we performed an ecological study....

  14. Information on blinding in registered records of clinical trials

    Directory of Open Access Journals (Sweden)

    Viergever Roderik F

    2012-11-01

    Full Text Available Abstract Information on blinding is part of the data that should be provided upon registration of a trial at a clinical trials registry. Reporting of blinding is often absent or of low quality in published articles of clinical trials. This study researched the presence and quality of information on blinding in registered records of clinical trials and highlights the important role of data-recording formats at clinical trial registries in ensuring high-quality registration.

  15. Clinical trial quality: From supervision to collaboration and beyond.

    Science.gov (United States)

    Meeker-O'Connell, Ann; Glessner, Coleen

    2018-02-01

    Over the past decade, clinical trial quality has evolved from an after-the-fact, reactive activity to one focused on the important work of evidence generation from well-designed trials. This article explores the role the Clinical Trials Transformation Initiative has played in advancing quality as a core element of clinical trial design, through project work that initially focused on monitoring but evolved into a holistic, prospective, and comprehensive quality by design approach to clinical trial design and conduct.

  16. Internet trials: participant experiences and perspectives

    Science.gov (United States)

    2012-01-01

    Background Use of the Internet to conduct randomised controlled trials is increasing, and provides potential to increase equity of access to medical research, increase the generalisability of trial results and decrease the costs involved in conducting large scale trials. Several studies have compared response rates, completeness of data, and reliability of surveys using the Internet and traditional methods, but very little is known about participants’ attitudes towards Internet-based randomised trials or their experience of participating in an Internet-based trial. Objective To obtain insights into the experiences and perspectives of participants in an Internet-based randomised controlled trial, their attitudes to the use of the Internet to conduct medical research, and their intentions regarding future participation in Internet research. Methods All English speaking participants in a recently completed Internet randomised controlled trial were invited to participate in an online survey. Results 1246 invitations were emailed. 416 participants completed the survey between May and October 2009 (33% response rate). Reasons given for participating in the Internet RCT fell into 4 main areas: personal interest in the research question and outcome, ease of participation, an appreciation of the importance of research and altruistic reasons. Participants’ comments and reflections on their experience of participating in a fully online trial were positive and less than half of participants would have participated in the trial had it been conducted using other means of data collection. However participants identified trade-offs between the benefits and downsides of participating in Internet-based trials. The main trade-off was between flexibility and convenience – a perceived benefit – and a lack connectedness and understanding – a perceived disadvantage. The other tradeoffs were in the areas of: ease or difficulty in use of the Internet; security, privacy and

  17. Internet trials: participant experiences and perspectives

    Directory of Open Access Journals (Sweden)

    Mathieu Erin

    2012-10-01

    Full Text Available Abstract Background Use of the Internet to conduct randomised controlled trials is increasing, and provides potential to increase equity of access to medical research, increase the generalisability of trial results and decrease the costs involved in conducting large scale trials. Several studies have compared response rates, completeness of data, and reliability of surveys using the Internet and traditional methods, but very little is known about participants’ attitudes towards Internet-based randomised trials or their experience of participating in an Internet-based trial. Objective To obtain insights into the experiences and perspectives of participants in an Internet-based randomised controlled trial, their attitudes to the use of the Internet to conduct medical research, and their intentions regarding future participation in Internet research. Methods All English speaking participants in a recently completed Internet randomised controlled trial were invited to participate in an online survey. Results 1246 invitations were emailed. 416 participants completed the survey between May and October 2009 (33% response rate. Reasons given for participating in the Internet RCT fell into 4 main areas: personal interest in the research question and outcome, ease of participation, an appreciation of the importance of research and altruistic reasons. Participants’ comments and reflections on their experience of participating in a fully online trial were positive and less than half of participants would have participated in the trial had it been conducted using other means of data collection. However participants identified trade-offs between the benefits and downsides of participating in Internet-based trials. The main trade-off was between flexibility and convenience – a perceived benefit – and a lack connectedness and understanding – a perceived disadvantage. The other tradeoffs were in the areas of: ease or difficulty in use of the Internet

  18. [Placebo-controlled trials in schizophrenia].

    Science.gov (United States)

    Melamed, Yuval; Davidson, Michael; Bleich, Avi

    2004-03-01

    Clinical trials involving human subjects give rise to ethical and medico-legal dilemmas. Essential research of new drugs may potentially expose patients to ineffective medications or to placebo. The complexity of the problem increases when dealing with mentally ill patients, for whom, on the one hand there is no known cure for their disease, and on the other hand, it is sometimes questionable whether or not they are able to provide informed consent to participate in clinical trials. The Israel Psychiatric Association decided to develop a position paper on the subject of placebo-controlled clinical trials in schizophrenia patients. Discussion groups were established, and the available material in the professional literature was examined, with an emphasis on recent developments. The Declaration of Helsinki and its amendments were analyzed, and experts in the field were consulted. Clinical drug trials for development of new medications are essential in all fields of medicine, especially in psychiatry. The requirement for a placebo arm in pharmaceutical trials presents ethical and clinical dilemmas that are especially complicated with regard to mentally ill persons whose free choice and ability to provide informed consent may be questionable. However, we do not believe that this predicament justifies unconditional rejection of placebo use in psychiatry, when it may provide substantial benefit for some patients. Simultaneously, it is our duty to provide stringent restrictions that will enable strict supervision over the scientific, clinical and ethical aspects of the trials. We propose the following criteria for approval of pharmaceutical trials that include a placebo arm: scientific justification; clinical and ethical justification; provision of informed consent; recruitment of patients hospitalized voluntarily; prevention of harm; administration of additional potential therapeutic interventions; benefit to patients participating in the study; control and follow

  19. The Steroids for Corneal Ulcers Trial

    Science.gov (United States)

    Srinivasan, Muthiah; Mascarenhas, Jeena; Rajaraman, Revathi; Ravindran, Meenakshi; Lalitha, Prajna; Glidden, David V.; Ray, Kathryn J.; Hong, Kevin C.; Oldenburg, Catherine E.; Lee, Salena M.; Zegans, Michael E.; McLeod, Stephen D.; Lietman, Thomas M.; Acharya, Nisha R.

    2013-01-01

    Objectives To provide comprehensive trial methods and baseline data for the Steroids for Corneal Ulcers Trial and to present epidemiological characteristics such as risk factors, causative organisms, and ulcer severity. Methods Baseline data from a 1:1 randomized, placebo-controlled, double-masked clinical trial comparing prednisolone phosphate, 1%, with placebo as adjunctive therapy for the treatment of bacterial corneal ulcers. Eligible patients had a culture-positive bacterial corneal ulcer and had been taking moxifloxacin for 48 hours. The primary outcome for the trial is best spectacle-corrected visual acuity at 3 months from enrollment. This report provides comprehensive baseline data, including best spectacle-corrected visual acuity, infiltrate size, microbio-logical results, and patient demographics, for patients enrolled in the trial. Results Of 500 patients enrolled, 97% were in India. Two hundred twenty patients (44%) were agricultural workers. Median baseline visual acuity was 0.84 logMAR (Snellen, 20/125) (interquartile range, 0.36-1.7; Snellen, 20/50 to counting fingers). Baseline visual acuity was not significantly different between the United States and India. Ulcers in India had larger infiltrate/scar sizes (P=.04) and deeper infiltrates (P=.04) and were more likely to be localized centrally (P=.002) than ulcers enrolled in the United States. Gram-positive bacteria were the most common organisms isolated from the ulcers (n=366, 72%). Conclusions The Steroids for Corneal Ulcers Trial will compare the use of a topical corticosteroid with placebo as adjunctive therapy for bacterial corneal ulcers. Patients enrolled in this trial had diverse ulcer severity and on average significantly reduced visual acuity at presentation. PMID:21987581

  20. Type 1 Diabetes TrialNet--an international collaborative clinical trials network.

    Science.gov (United States)

    Skyler, Jay S; Greenbaum, Carla J; Lachin, John M; Leschek, Ellen; Rafkin-Mervis, Lisa; Savage, Peter; Spain, Lisa

    2008-12-01

    Type 1 Diabetes TrialNet is an international consortium of clinical research centers aimed at the prevention or delay of type 1 diabetes (T1D). The fundamental goal of TrialNet is to counter the T1D disease process by immune modulation and/or enhancement of beta cell proliferation and regeneration. To achieve this goal, TrialNet researchers are working to better understand the natural history of the disease, to identify persons at risk, and to clinically evaluate novel therapies that balance potential risks and benefits. The particular focus is on studies of preventive measures. In addition, TrialNet evaluates therapies in individuals with newly diagnosed T1D with preserved beta cell function to help determine the risk/benefit profile and gain an initial assessment of potential efficacy in preservation of beta cell function, so that promising agents can be studied in prevention trials. In addition, TrialNet evaluates methodologies that enhance the conduct of its clinical trials, which includes tests of outcome assessment methodology, the evaluation of surrogate markers, and mechanistic studies laying the foundation for future clinical trials.

  1. Trial-to-Trial Carryover in Auditory Short-Term Memory

    Science.gov (United States)

    Visscher, Kristina M.; Kahana, Michael J.; Sekuler, Robert

    2009-01-01

    Using a short-term recognition memory task, the authors evaluated the carryover across trials of 2 types of auditory information: the characteristics of individual study sounds (item information) and the relationships between the study sounds (study set homogeneity). On each trial, subjects heard 2 successive broadband study sounds and then…

  2. Lung-MAP Launches: First Precision Medicine Trial From National Clinical Trials Network

    Science.gov (United States)

    A unique public-private collaboration today announced the initiation of the Lung Cancer Master Protocol (Lung-MAP) trial, a multi-drug, multi-arm, biomarker-driven clinical trial for patients with advanced squamous cell lung cancer. Squamous cell carcinom

  3. Massed Trials versus Trials Embedded into Game Play: Child Outcomes and Preference

    Science.gov (United States)

    Ledford, Jennifer R.; Chazin, Kate T.; Harbin, Emilee R.; Ward, Sarah E.

    2017-01-01

    Limited data are available regarding how response prompting procedures should be used in early childhood settings. The purpose of this study was to compare the efficiency of progressive time delay instruction presented via two trial arrangements: massed and embedded. During massed trial sessions, a short instructional session was conducted,…

  4. Clinical trials recruitment planning: A proposed framework from the Clinical Trials Transformation Initiative.

    Science.gov (United States)

    Huang, Grant D; Bull, Jonca; Johnston McKee, Kelly; Mahon, Elizabeth; Harper, Beth; Roberts, Jamie N

    2018-03-01

    Patient recruitment is widely recognized as a key determinant of success for clinical trials. Yet a substantial number of trials fail to reach recruitment goals-a situation that has important scientific, financial, ethical, and policy implications. Further, there are important effects on stakeholders who directly contribute to the trial including investigators, sponsors, and study participants. Despite efforts over multiple decades to identify and address barriers, recruitment challenges persist. To advance a more comprehensive approach to trial recruitment, the Clinical Trials Transformation Initiative (CTTI) convened a project team to examine the challenges and to issue actionable, evidence-based recommendations for improving recruitment planning that extend beyond common study-specific strategies. We describe our multi-stakeholder effort to develop a framework that delineates three areas essential to strategic recruitment planning efforts: (1) trial design and protocol development, (2) trial feasibility and site selection, and (3) communication. Our recommendations propose an upstream approach to recruitment planning that has the potential to produce greater impact and reduce downstream barriers. Additionally, we offer tools to help facilitate adoption of the recommendations. We hope that our framework and recommendations will serve as a guide for initial efforts in clinical trial recruitment planning irrespective of disease or intervention focus, provide a common basis for discussions in this area and generate targets for further analysis and continual improvement. Copyright © 2018 The Authors. Published by Elsevier Inc. All rights reserved.

  5. Australasian Experience and Trials in Sentinel Lymph Node Biopsy: The RACS SNAC Trial

    Directory of Open Access Journals (Sweden)

    Owen A. Ung

    2004-10-01

    Conclusions: The SNAC trial is one of the fastest accruing clinical trials in Australasia. It is on track to determine whether differences in morbidity, with equivalent cancer-related outcomes, exist between SLNB and AC for women with early breast cancer.

  6. The Trial of Napoleon: A Case Study for Using Mock Trials.

    Science.gov (United States)

    MacKay, Charles

    2000-01-01

    Describes a course entitled "The Trial of Napoleon Bonaparte" that focuses on a fictitious mock trial of Napoleon Bonaparte to answer the question: did Napoleon pervert or preserve the gain of the French Revolution? Discusses the strengths and weaknesses of the course. (CMK)

  7. Using regional broccoli trial data to select experimental hybrids for input into advanced yield trials

    Science.gov (United States)

    A large amount of phenotypic trait data are being generated in regional trials that are implemented as part of the Specialty Crop Research Initiative (SCRI) project entitled “Establishing an Eastern Broccoli Industry”. These data are used to identify the best entries in the trials for inclusion in ...

  8. Are pilot trials useful for predicting randomisation and attrition rates in definitive studies: A review of publicly funded trials

    Science.gov (United States)

    Whitehead, Amy; Pottrill, Edward; Julious, Steven A; Walters, Stephen J

    2018-01-01

    Background/aims: External pilot trials are recommended for testing the feasibility of main or confirmatory trials. However, there is little evidence that progress in external pilot trials actually predicts randomisation and attrition rates in the main trial. To assess the use of external pilot trials in trial design, we compared randomisation and attrition rates in publicly funded randomised controlled trials with rates in their pilots. Methods: Randomised controlled trials for which there was an external pilot trial were identified from reports published between 2004 and 2013 in the Health Technology Assessment Journal. Data were extracted from published papers, protocols and reports. Bland–Altman plots and descriptive statistics were used to investigate the agreement of randomisation and attrition rates between the full and external pilot trials. Results: Of 561 reports, 41 were randomised controlled trials with pilot trials and 16 met criteria for a pilot trial with sufficient data. Mean attrition and randomisation rates were 21.1% and 50.4%, respectively, in the pilot trials and 16.8% and 65.2% in the main. There was minimal bias in the pilot trial when predicting the main trial attrition and randomisation rate. However, the variation was large: the mean difference in the attrition rate between the pilot and main trial was −4.4% with limits of agreement of −37.1% to 28.2%. Limits of agreement for randomisation rates were −47.8% to 77.5%. Conclusion: Results from external pilot trials to estimate randomisation and attrition rates should be used with caution as comparison of the difference in the rates between pilots and their associated full trial demonstrates high variability. We suggest using internal pilot trials wherever appropriate. PMID:29361833

  9. Publication and non-publication of drug trial results: a 10-year cohort of trials in Norwegian general practice.

    Science.gov (United States)

    Brænd, Anja Maria; Straand, Jørund; Jakobsen, Rune Bruhn; Klovning, Atle

    2016-04-11

    Previously, we identified a 10-year cohort of protocols from applications to the Norwegian Medicines Agency 1998-2007, consisting of 196 drug trials in general practice. The aim of this study was to examine whether trial results were published and whether trial funding and conflicts of interest were reported. Cohort study of trials with systematic searches for published results. Clinical drug trials in Norwegian general practice. We performed systematic literature searches of MEDLINE, Embase and CENTRAL to identify publications originating from each trial using characteristics such as test drug, comparator and patient groups as search terms. When no publication was identified, we contacted trial sponsors for information regarding trial completion and reference to any publications. We determined the frequency of publication of trial results and trial characteristics associated with publication of results. Of the 196 trials, 5 were never started. Of the remaining 191 trials, 71% had results published in a journal, 11% had results publicly available elsewhere and 18% of trials had no results available. Publication was more common among trials with an active comparator drug (χ(2) test, p=0.040), with a larger number of patients (total sample size≥median, p=0.010) and with a longer trial period (duration≥median, p=0.025). Trial funding was reported in 85% of publications and increased over time, as did reporting of conflicts of interest among authors. Among the 134 main journal articles from the trials, 60% presented statistically significant results for the investigational drug, and the conclusion of the article was favourable towards the test drug in 78% of papers. We did not identify any journal publication of results for 29% of the general practice drug trials. Trials with an active comparator, larger and longer trials were more likely to be published. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a

  10. Ongoing EEG phase as a trial-by-trial predictor of perceptual and attentional variability

    Directory of Open Access Journals (Sweden)

    Rufin eVanRullen

    2011-04-01

    Full Text Available Even in well-controlled laboratory environments, apparently identical repetitions of an experimental trial can give rise to highly variable perceptual outcomes and behavioral responses. This variability is generally discarded as a reflection of intrinsic noise in neuronal systems. However, part of this variability may be accounted for by trial-by-trial fluctuations of the phase of ongoing oscillations at the moment of stimulus presentation. For example, the phase of an EEG oscillation reflecting the rapid waxing and waning of sustained attention can predict the perception of a subsequent visual stimulus at threshold. Similar ongoing periodicities account for a portion of the trial-by-trial variability of visual reaction times. We review the available experimental evidence linking ongoing EEG phase to perceptual and attentional variability, and the corresponding methodology. We propose future tests of this relation, and discuss the theoretical implications for understanding the neuronal dynamics of sensory perception.

  11. Clinical trial optimization: Monte Carlo simulation Markov model for planning clinical trials recruitment.

    Science.gov (United States)

    Abbas, Ismail; Rovira, Joan; Casanovas, Josep

    2007-05-01

    The patient recruitment process of clinical trials is an essential element which needs to be designed properly. In this paper we describe different simulation models under continuous and discrete time assumptions for the design of recruitment in clinical trials. The results of hypothetical examples of clinical trial recruitments are presented. The recruitment time is calculated and the number of recruited patients is quantified for a given time and probability of recruitment. The expected delay and the effective recruitment durations are estimated using both continuous and discrete time modeling. The proposed type of Monte Carlo simulation Markov models will enable optimization of the recruitment process and the estimation and the calibration of its parameters to aid the proposed clinical trials. A continuous time simulation may minimize the duration of the recruitment and, consequently, the total duration of the trial.

  12. Euthanasia on trial: examining public attitudes toward non-physician-assisted death.

    Science.gov (United States)

    Pfeifer, J E; Brigham, J C; Robinson, T

    1996-01-01

    This study investigated the influence of various contextual effects on the decisions of subjects evaluating a case of nonphysician-assisted suicide. Subjects viewed a videotaped deposition of an individual emotionally or nonemotionally describing how he assisted in the death of his terminally ill wife by disconnecting her respirator or shooting her in the head. The deposition was followed by jury instructions that outlined the duties of the subject and, in some cases, was followed by a nullification instruction that informed the subjects of their right to ignore the law in this case if they felt it would culminate in an unfair verdict. After viewing the videotape, subjects were asked to rate the guilt of the individual as well as their confidence in this rating. Results indicate that the means of death and the type of instruction significantly affect guilt ratings. The implications of these findings are discussed.

  13. UK Dermatology Clinical Trials Network's STOP GAP trial (a multicentre trial of prednisolone versus ciclosporin for pyoderma gangrenosum): protocol for a randomised controlled trial.

    Science.gov (United States)

    Craig, Fiona F; Thomas, Kim S; Mitchell, Eleanor J; Williams, Hywel C; Norrie, John; Mason, James M; Ormerod, Anthony D

    2012-04-28

    Pyoderma gangrenosum (PG) is a rare inflammatory skin disorder characterised by painful and rapidly progressing skin ulceration. PG can be extremely difficult to treat and patients often require systemic immunosuppression. Recurrent lesions of PG are common, but the relative rarity of this condition means that there is a lack of published evidence regarding its treatment. A systematic review published in 2005 found no randomised controlled trials (RCTs) relating to the treatment of PG. Since this time, one small RCT has been published comparing infliximab to placebo, but none of the commonly used systemic treatments for PG have been formally assessed. The UK Dermatology Clinical Trials Network's STOP GAP Trial has been designed to address this lack of trial evidence. The objective is to assess whether oral ciclosporin is more effective than oral prednisolone for the treatment of PG. The trial design is a two-arm, observer-blind, parallel-group, randomised controlled trial comparing ciclosporin (4 mg/kg/day) to prednisolone (0.75 mg/kg/day). A total of 140 participants are to be recruited over a period of 4 years, from up to 50 hospitals in the UK and Eire. Primary outcome of velocity of healing at 6 weeks is assessed blinded to treatment allocation (using digital images of the ulcers). Secondary outcomes include: (i) time to healing; (ii) global assessment of improvement; (iii) PG inflammation assessment scale score; (iv) self-reported pain; (v) health-related quality of life; (vi) time to recurrence; (vii) treatment failures; (viii) adverse reactions to study medications; and (ix) cost effectiveness/utility. Patients with a clinical diagnosis of PG (excluding granulomatous PG); measurable ulceration (that is, not pustular PG); and patients aged over 18 years old who are able to give informed consent are included in the trial. Randomisation is by computer generated code using permuted blocks of randomly varying size, stratified by lesion size, and

  14. Recent clinical trials in valvular heart disease.

    Science.gov (United States)

    Kiss, Daniel; Anwaruddin, Saif

    2017-07-01

    With widespread adoption of transcatheter aortic valve replacement, there has been a change in the approach to management of valvular heart disease. New interest has taken hold in transcatheter therapies for valvular heart disease, as well as research into pathophysiology and progression of disease. Additionally, several key trials have further refined our understanding of surgical management of valvular heart disease. This review will elucidate recent clinical trial data leading to changes in practice. There have been several landmark trials expanding the indications for transcatheter aortic valve replacement. Additionally, although still early, trials are beginning to demonstrate the feasibility and safety of transcatheter mitral valves. Options for transcatheter management of right-sided valvular disease continue to evolve, and these are areas of active investigation. The emergence of novel therapies for valvular heart disease has expanded the management options available, allowing physicians to better individualize treatment of patients with valvular heart disease. This review will focus on the recent (within 2 years) trials in this field of interest.

  15. Quality of clinical trials: A moving target

    Science.gov (United States)

    Bhatt, Arun

    2011-01-01

    Quality of clinical trials depends on data integrity and subject protection. Globalization, outsourcing and increasing complexicity of clinical trials have made the target of achieving global quality challenging. The quality, as judged by regulatory inspections of the investigator sites, sponsors/contract research organizations and Institutional Review Board, has been of concern to the US Food and Drug Administration, as there has been hardly any change in frequency and nature of common deficiencies. To meet the regulatory expectations, the sponsors need to improve quality by developing systems with specific standards for each clinical trial process. The quality systems include: personnel roles and responsibilities, training, policies and procedures, quality assurance and auditing, document management, record retention, and reporting and corrective and preventive action. With an objective to improve quality, the FDA has planned new inspection approaches such as risk-based inspections, surveillance inspections, real-time oversight, and audit of sponsor quality systems. The FDA has partnered with Duke University for Clinical Trials Transformation Initiative, which will conduct research projects on design principles, data quality and quantity including monitoring, study start-up, and adverse event reporting. These recent initiatives will go a long way in improving quality of clinical trials. PMID:22145122

  16. Quality of clinical trials: A moving target

    Directory of Open Access Journals (Sweden)

    Arun Bhatt

    2011-01-01

    Full Text Available Quality of clinical trials depends on data integrity and subject protection. Globalization, outsourcing and increasing complexicity of clinical trials have made the target of achieving global quality challenging. The quality, as judged by regulatory inspections of the investigator sites, sponsors/contract research organizations and Institutional Review Board, has been of concern to the US Food and Drug Administration, as there has been hardly any change in frequency and nature of common deficiencies. To meet the regulatory expectations, the sponsors need to improve quality by developing systems with specific standards for each clinical trial process. The quality systems include: personnel roles and responsibilities, training, policies and procedures, quality assurance and auditing, document management, record retention, and reporting and corrective and preventive action. With an objective to improve quality, the FDA has planned new inspection approaches such as risk-based inspections, surveillance inspections, real-time oversight, and audit of sponsor quality systems. The FDA has partnered with Duke University for Clinical Trials Transformation Initiative, which will conduct research projects on design principles, data quality and quantity including monitoring, study start-up, and adverse event reporting. These recent initiatives will go a long way in improving quality of clinical trials.

  17. Biomarkers in T cell therapy clinical trials

    Directory of Open Access Journals (Sweden)

    Kalos Michael

    2011-08-01

    Full Text Available Abstract T cell therapy represents an emerging and promising modality for the treatment of both infectious disease and cancer. Data from recent clinical trials have highlighted the potential for this therapeutic modality to effect potent anti-tumor activity. Biomarkers, operationally defined as biological parameters measured from patients that provide information about treatment impact, play a central role in the development of novel therapeutic agents. In the absence of information about primary clinical endpoints, biomarkers can provide critical insights that allow investigators to guide the clinical development of the candidate product. In the context of cell therapy trials, the definition of biomarkers can be extended to include a description of parameters of the cell product that are important for product bioactivity. This review will focus on biomarker studies as they relate to T cell therapy trials, and more specifically: i. An overview and description of categories and classes of biomarkers that are specifically relevant to T cell therapy trials, and ii. Insights into future directions and challenges for the appropriate development of biomarkers to evaluate both product bioactivity and treatment efficacy of T cell therapy trials.

  18. [Ethical principles of clinical trials in minors].

    Science.gov (United States)

    Koch, H J; Raschka, C

    2002-12-05

    Clinical trials in volunteers and patients are essential to ensure rational treatment of patients. As a rule, drugs are routinely developed for adults, but children are excluded. A major reason for this restriction are ethical justifications, in particular the lack of autonomy on the part of children. The principle of fairness, however, requires that everyone should benefit from progress. Industry, science and society are therefore called upon to find ways of making available safe and adequate treatment for children as quickly as possible, by defining the required conditions for pediatric clinical trials. Important principles are minimal risk, minimal invasivity, rapid decision-making, and careful documentation of trial results. Dynamic ethical principles, such as autonomy and competence in adolescents must be considered on equal footing with existing international GCP guidelines. Aspects of child psychology indicate that the autonomy of adolescents should be respected. Where economic incentives for such trials are absent, for example, in the case of non-pharmacological problems, pediatric trials must be considered a task for society as a whole.

  19. 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.

  20. SPIRIT 2013 Statement: defining standard protocol items for clinical trials.

    Science.gov (United States)

    Chan, An-Wen; Tetzlaff, Jennifer M; Altman, Douglas G; Laupacis, Andreas; Gøtzsche, Peter C; Krle A-Jerić, Karmela; Hrobjartsson, Asbjørn; Mann, Howard; Dickersin, Kay; Berlin, Jesse A; Dore, Caroline J; Parulekar, Wendy R; Summerskill, William S M; Groves, Trish; Schulz, Kenneth F; Sox, Harold C; Rockhold, Frank W; Rennie, Drummond; Moher, David

    2015-12-01

    The protocol of a clinical trial serves as the foundation for study planning, conduct, reporting, and appraisal. However, trial protocols and existing protocol guidelines vary greatly in content and quality. This article describes the systematic development and scope of SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013, a guideline for the minimum content of a clinical trial protocol. The 33-item SPIRIT checklist applies to protocols for all clinical trials and focuses on content rather than format. The checklist recommends a full description of what is planned; it does not prescribe how to design or conduct a trial. By providing guidance for key content, the SPIRIT recommendations aim to facilitate the drafting of high-quality protocols. Adherence to SPIRIT would also enhance the transparency and completeness of trial protocols for the benefit of investigators, trial participants, patients, sponsors, funders, research ethics committees or institutional review boards, peer reviewers, journals, trial registries, policymakers, regulators, and other key stakeholders.