The Participants In The Trial

Author : Institute of Medicine,Board on Health Sciences Policy,Committee on Strategies for Responsible Sharing of Clinical Trial Data
Publisher : National Academies Press
Page : 304 pages
File Size : 49,5 Mb
Release : 2015-04-20
Category : Medical
ISBN : 9780309316323

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Sharing Clinical Trial Data by Institute of Medicine,Board on Health Sciences Policy,Committee on Strategies for Responsible Sharing of Clinical Trial Data Pdf

Data sharing can accelerate new discoveries by avoiding duplicative trials, stimulating new ideas for research, and enabling the maximal scientific knowledge and benefits to be gained from the efforts of clinical trial participants and investigators. At the same time, sharing clinical trial data presents risks, burdens, and challenges. These include the need to protect the privacy and honor the consent of clinical trial participants; safeguard the legitimate economic interests of sponsors; and guard against invalid secondary analyses, which could undermine trust in clinical trials or otherwise harm public health. Sharing Clinical Trial Data presents activities and strategies for the responsible sharing of clinical trial data. With the goal of increasing scientific knowledge to lead to better therapies for patients, this book identifies guiding principles and makes recommendations to maximize the benefits and minimize risks. This report offers guidance on the types of clinical trial data available at different points in the process, the points in the process at which each type of data should be shared, methods for sharing data, what groups should have access to data, and future knowledge and infrastructure needs. Responsible sharing of clinical trial data will allow other investigators to replicate published findings and carry out additional analyses, strengthen the evidence base for regulatory and clinical decisions, and increase the scientific knowledge gained from investments by the funders of clinical trials. The recommendations of Sharing Clinical Trial Data will be useful both now and well into the future as improved sharing of data leads to a stronger evidence base for treatment. This book will be of interest to stakeholders across the spectrum of research--from funders, to researchers, to journals, to physicians, and ultimately, to patients.

Author : Institute of Medicine,Board on Health Sciences Policy,Committee on Strategies for Small-Number-Participant Clinical Research Trials
Publisher : National Academies Press
Page : 222 pages
File Size : 40,7 Mb
Release : 2001-01-01
Category : Medical
ISBN : 0309171148

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Small Clinical Trials by Institute of Medicine,Board on Health Sciences Policy,Committee on Strategies for Small-Number-Participant Clinical Research Trials Pdf

Clinical trials are used to elucidate the most appropriate preventive, diagnostic, or treatment options for individuals with a given medical condition. Perhaps the most essential feature of a clinical trial is that it aims to use results based on a limited sample of research participants to see if the intervention is safe and effective or if it is comparable to a comparison treatment. Sample size is a crucial component of any clinical trial. A trial with a small number of research participants is more prone to variability and carries a considerable risk of failing to demonstrate the effectiveness of a given intervention when one really is present. This may occur in phase I (safety and pharmacologic profiles), II (pilot efficacy evaluation), and III (extensive assessment of safety and efficacy) trials. Although phase I and II studies may have smaller sample sizes, they usually have adequate statistical power, which is the committee's definition of a "large" trial. Sometimes a trial with eight participants may have adequate statistical power, statistical power being the probability of rejecting the null hypothesis when the hypothesis is false. Small Clinical Trials assesses the current methodologies and the appropriate situations for the conduct of clinical trials with small sample sizes. This report assesses the published literature on various strategies such as (1) meta-analysis to combine disparate information from several studies including Bayesian techniques as in the confidence profile method and (2) other alternatives such as assessing therapeutic results in a single treated population (e.g., astronauts) by sequentially measuring whether the intervention is falling above or below a preestablished probability outcome range and meeting predesigned specifications as opposed to incremental improvement.

Author : Peter G. Smith,R. H. Morrow,Richard H. Morrow,David A. Ross
Publisher : Oxford University Press, USA
Page : 479 pages
File Size : 44,6 Mb
Release : 2015
Category : Medical
ISBN : 9780198732860

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Field Trials of Health Interventions by Peter G. Smith,R. H. Morrow,Richard H. Morrow,David A. Ross Pdf

"IEA, International Epidemiological Association, Welcome Trust."

Author : National Research Council,Division of Behavioral and Social Sciences and Education,Committee on National Statistics,Panel on Handling Missing Data in Clinical Trials
Publisher : National Academies Press
Page : 163 pages
File Size : 44,5 Mb
Release : 2010-12-21
Category : Medical
ISBN : 9780309186513

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The Prevention and Treatment of Missing Data in Clinical Trials by National Research Council,Division of Behavioral and Social Sciences and Education,Committee on National Statistics,Panel on Handling Missing Data in Clinical Trials Pdf

Randomized clinical trials are the primary tool for evaluating new medical interventions. Randomization provides for a fair comparison between treatment and control groups, balancing out, on average, distributions of known and unknown factors among the participants. Unfortunately, these studies often lack a substantial percentage of data. This missing data reduces the benefit provided by the randomization and introduces potential biases in the comparison of the treatment groups. Missing data can arise for a variety of reasons, including the inability or unwillingness of participants to meet appointments for evaluation. And in some studies, some or all of data collection ceases when participants discontinue study treatment. Existing guidelines for the design and conduct of clinical trials, and the analysis of the resulting data, provide only limited advice on how to handle missing data. Thus, approaches to the analysis of data with an appreciable amount of missing values tend to be ad hoc and variable. The Prevention and Treatment of Missing Data in Clinical Trials concludes that a more principled approach to design and analysis in the presence of missing data is both needed and possible. Such an approach needs to focus on two critical elements: (1) careful design and conduct to limit the amount and impact of missing data and (2) analysis that makes full use of information on all randomized participants and is based on careful attention to the assumptions about the nature of the missing data underlying estimates of treatment effects. In addition to the highest priority recommendations, the book offers more detailed recommendations on the conduct of clinical trials and techniques for analysis of trial data.

Author : Institute of Medicine,Board on Health Sciences Policy,Committee on Clinical Research Involving Children
Publisher : National Academies Press
Page : 445 pages
File Size : 52,7 Mb
Release : 2004-07-09
Category : Medical
ISBN : 9780309133388

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Ethical Conduct of Clinical Research Involving Children by Institute of Medicine,Board on Health Sciences Policy,Committee on Clinical Research Involving Children Pdf

In recent decades, advances in biomedical research have helped save or lengthen the lives of children around the world. With improved therapies, child and adolescent mortality rates have decreased significantly in the last half century. Despite these advances, pediatricians and others argue that children have not shared equally with adults in biomedical advances. Even though we want children to benefit from the dramatic and accelerating rate of progress in medical care that has been fueled by scientific research, we do not want to place children at risk of being harmed by participating in clinical studies. Ethical Conduct of Clinical Research Involving Children considers the necessities and challenges of this type of research and reviews the ethical and legal standards for conducting it. It also considers problems with the interpretation and application of these standards and conduct, concluding that while children should not be excluded from potentially beneficial clinical studies, some research that is ethically permissible for adults is not acceptable for children, who usually do not have the legal capacity or maturity to make informed decisions about research participation. The book looks at the need for appropriate pediatric expertise at all stages of the design, review, and conduct of a research project to effectively implement policies to protect children. It argues persuasively that a robust system for protecting human research participants in general is a necessary foundation for protecting child research participants in particular.

Author : Lynn Buchanan
Publisher : Unknown
Page : 29 pages
File Size : 54,7 Mb
Release : 2005-01-01
Category : Jury
ISBN : 1876045310

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Juror's Handbook by Lynn Buchanan Pdf

Jury service is one of the most important civic duties a person can undertake, yet it is often poorly understood. This booklet has been prepared in consultation with the Juries Commissioner's Office. It answers frequently asked questions about jury service and provides prospective jurors with a clear explanation of their responsibilities and the processes involved in trials. All potential jurors will receive a copy when they attend for jury service.

Author : National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Sciences Policy,Forum on Drug Discovery, Development, and Translation
Publisher : National Academies Press
Page : 127 pages
File Size : 50,8 Mb
Release : 2019-11-16
Category : Medical
ISBN : 9780309494885

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Virtual Clinical Trials by National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Sciences Policy,Forum on Drug Discovery, Development, and Translation Pdf

Successful drug development relies on accurate and efficient clinical trials to deliver the best and most effective pharmaceuticals and clinical care to patients. However, the current model for clinical trials is outdated, inefficient and costly. Clinical trials are limited by small sample sizes that do not reflect variations among patients in the real world, financial burdens on participants, and slow processes, and these factors contribute to the disconnect between clinical research and clinical practice. On November 28-29, the National Academies of Sciences, Engineering, and Medicine convened a workshop to investigate the current clinical trials system and explore the potential benefits and challenges of implementing virtual clinical trials as an enhanced alternative for the future. This publication summarizes the presentations and discussions from the workshop.

Author : JoAnn Pfeiffer,Cris Wells
Publisher : CRC Press
Page : 292 pages
File Size : 54,7 Mb
Release : 2017-05-18
Category : Mathematics
ISBN : 9781315299778

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A Practical Guide to Managing Clinical Trials by JoAnn Pfeiffer,Cris Wells Pdf

A Practical Guide to Managing Clinical Trials is a basic, comprehensive guide to conducting clinical trials. Designed for individuals working in research site operations, this user-friendly reference guides the reader through each step of the clinical trial process from site selection, to site set-up, subject recruitment, study visits, and to study close-out. Topics include staff roles/responsibilities/training, budget and contract review and management, subject study visits, data and document management, event reporting, research ethics, audits and inspections, consent processes, IRB, FDA regulations, and good clinical practices. Each chapter concludes with a review of key points and knowledge application. Unique to this book is "A View from India," a chapter-by-chapter comparison of clinical trial practices in India versus the U.S. Throughout the book and in Chapter 10, readers will glimpse some of the challenges and opportunities in the emerging and growing market of Indian clinical trials.

Author : National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Sciences Policy,Committee on the Return of Individual-Specific Research Results Generated in Research Laboratories
Publisher : National Academies Press
Page : 399 pages
File Size : 41,7 Mb
Release : 2018-09-23
Category : Medical
ISBN : 9780309475174

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Returning Individual Research Results to Participants by National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Sciences Policy,Committee on the Return of Individual-Specific Research Results Generated in Research Laboratories Pdf

When is it appropriate to return individual research results to participants? The immense interest in this question has been fostered by the growing movement toward greater transparency and participant engagement in the research enterprise. Yet, the risks of returning individual research resultsâ€"such as results with unknown validityâ€"and the associated burdens on the research enterprise are competing considerations. Returning Individual Research Results to Participants reviews the current evidence on the benefits, harms, and costs of returning individual research results, while also considering the ethical, social, operational, and regulatory aspects of the practice. This report includes 12 recommendations directed to various stakeholdersâ€"investigators, sponsors, research institutions, institutional review boards (IRBs), regulators, and participantsâ€"and are designed to help (1) support decision making regarding the return of results on a study-by-study basis, (2) promote high-quality individual research results, (3) foster participant understanding of individual research results, and (4) revise and harmonize current regulations.

Author : Henry A. Glick,Jalpa A. Doshi,Seema S. Sonnad
Publisher : Handbooks in Health Economic E
Page : 265 pages
File Size : 46,7 Mb
Release : 2014-10-02
Category : Business & Economics
ISBN : 9780199685028

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Economic Evaluation in Clinical Trials by Henry A. Glick,Jalpa A. Doshi,Seema S. Sonnad Pdf

It is increasingly important to examine the relationship between the outcomes of a clinical trial and the costs of the medical therapy under study. This book provides a practical guide to the techniques and issues involved in conducting economic evaluation in ongoing clinical trials, supported with examples.

Author : Mark J. Campbell,David Putrino,Cornelia Frank,Adam Joseph Toth
Publisher : Frontiers Media SA
Page : 117 pages
File Size : 49,9 Mb
Release : 2021-06-16
Category : Science
ISBN : 9782889668816

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Progress in Computer Gaming and Esports: Neurocognitive and Motor Perspectives by Mark J. Campbell,David Putrino,Cornelia Frank,Adam Joseph Toth Pdf

Author : Daniela M. Pfabigan,Ulrich S. Tran
Publisher : Frontiers Media SA
Page : 98 pages
File Size : 42,7 Mb
Release : 2015-08-21
Category : Behavioural studies
ISBN : 9782889196401

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Behavioral and Physiological Bases of Attentional Biases: Paradigms, Participants, and Stimuli by Daniela M. Pfabigan,Ulrich S. Tran Pdf

Attentional biases (ABs) play a prominent role in the development and maintenance of clinically relevant symptoms of, for example, anxiety and depression. In particular, increased attentional orienting and preoccupation with biologically relevant and mood-congruent stimuli has been observed, suggesting that the visual-attentional system is overly sensitive towards threat cues and avoidant of cues of reward in these disorders. First, several experimental paradigms have been used to assess ABs, e.g., the dot probe task, the emotional stroop task, and the spatial cueing task amongst others. Yet, these paradigms are based on different theoretical backgrounds and target different stages of the attentional process. Thus, different paradigms provided converging as well as diverging evidence with regard to ABs. However, it is often not entirely clear to what extent this reflects real differences and commonalities, or is caused by differences in methodology. For example, behavioral reaction time data can only provide a snapshot of selective attention. Measuring event-related potentials, eye movements, or functional brain imaging data enables exploring the exact temporal and spatial dynamics of attentional processes. Moreover, neuroimaging data reveal specific cortical networks involved in directing attention toward a stimulus or disengaging from it. Second, ABs have been mainly discussed as symptoms of psychopathology, while results in healthy participants are still scarce; previous studies mostly compared extreme groups. However, a comprehensive theoretical and empirical account of ABs in psychopathology also requires a thorough account of ABs in the general healthy population. Moreover, the effect of gender, as an important contributing factor in processing of emotional stimuli, has also not been considered systematically in previous research. Third, a variety of stimuli has been used in the assessment of ABs. So far, mostly facial or word stimuli have been applied. However, in everyday life not only facial emotion recognition but also a fast evaluation of complex social situations is important to be effective in social interactions. Recent research started using more complex stimuli to raise ecological validity. However, the use of ecologically valid stimuli poses some methodological challenges and needs to be applied more systematically. The aim of this research topic is to integrate different paradigms and stimuli, addressing individuals from the whole range of the population continuum, and to apply different methodological approaches. It is intended to bring together expertise in stimulus selection, timing and implementing issues, advancing and broadening the overall understanding of ABs.

Author : Demo-Droit Programme,Council of Europe,Themis (Project)
Publisher : Council of Europe
Page : 128 pages
File Size : 50,7 Mb
Release : 1997-01-01
Category : Political Science
ISBN : 9287132216

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Les acteurs du procès by Demo-Droit Programme,Council of Europe,Themis (Project) Pdf

Council of Europe legal co-operation with central and eastern European countries.

Author : Julian P. T. Higgins,Sally Green
Publisher : Wiley
Page : 672 pages
File Size : 55,6 Mb
Release : 2008-11-24
Category : Medical
ISBN : 0470699515

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Cochrane Handbook for Systematic Reviews of Interventions by Julian P. T. Higgins,Sally Green Pdf

Healthcare providers, consumers, researchers and policy makers are inundated with unmanageable amounts of information, including evidence from healthcare research. It has become impossible for all to have the time and resources to find, appraise and interpret this evidence and incorporate it into healthcare decisions. Cochrane Reviews respond to this challenge by identifying, appraising and synthesizing research-based evidence and presenting it in a standardized format, published in The Cochrane Library (www.thecochranelibrary.com). The Cochrane Handbook for Systematic Reviews of Interventions contains methodological guidance for the preparation and maintenance of Cochrane intervention reviews. Written in a clear and accessible format, it is the essential manual for all those preparing, maintaining and reading Cochrane reviews. Many of the principles and methods described here are appropriate for systematic reviews applied to other types of research and to systematic reviews of interventions undertaken by others. It is hoped therefore that this book will be invaluable to all those who want to understand the role of systematic reviews, critically appraise published reviews or perform reviews themselves.

Author : Carlos Vaz De Carvalho,Carina Soledad González González,Elvira Popescu,Jože Rugelj
Publisher : Frontiers Media SA
Page : 132 pages
File Size : 42,9 Mb
Release : 2021-06-28
Category : Science
ISBN : 9782889669448

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Serious Games by Carlos Vaz De Carvalho,Carina Soledad González González,Elvira Popescu,Jože Rugelj Pdf