Sharing Clinical Trial Data

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Publisher : National Academies Press
ISBN 13 : 0309316324
Total Pages : 236 pages
Book Rating : 4.3/5 (93 download)

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Book Synopsis Sharing Clinical Trial Data by : Institute of Medicine

Download or read book Sharing Clinical Trial Data written by Institute of Medicine and published by National Academies Press. This book was released on 2015-04-20 with total page 236 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Wild and Scenic River Study Report and Final Environmental Impact Statement on the Nolichucky River

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Author :
Publisher :
ISBN 13 :
Total Pages : 102 pages
Book Rating : 4.3/5 (21 download)

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Book Synopsis Wild and Scenic River Study Report and Final Environmental Impact Statement on the Nolichucky River by :

Download or read book Wild and Scenic River Study Report and Final Environmental Impact Statement on the Nolichucky River written by and published by . This book was released on 1994 with total page 102 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Basic Concept and Outline of Final Study Report

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Publisher :
ISBN 13 :
Total Pages : 33 pages
Book Rating : 4.:/5 (255 download)

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Book Synopsis Basic Concept and Outline of Final Study Report by : Leo W. Weisbecker

Download or read book Basic Concept and Outline of Final Study Report written by Leo W. Weisbecker and published by . This book was released on 1975 with total page 33 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Principles and Practice of Clinical Research

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Author :
Publisher : Elsevier
ISBN 13 : 0080489567
Total Pages : 447 pages
Book Rating : 4.0/5 (84 download)

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Book Synopsis Principles and Practice of Clinical Research by : John I. Gallin

Download or read book Principles and Practice of Clinical Research written by John I. Gallin and published by Elsevier. This book was released on 2011-04-28 with total page 447 pages. Available in PDF, EPUB and Kindle. Book excerpt: The second edition of this innovative work again provides a unique perspective on the clinical discovery process by providing input from experts within the NIH on the principles and practice of clinical research. Molecular medicine, genomics, and proteomics have opened vast opportunities for translation of basic science observations to the bedside through clinical research. As an introductory reference it gives clinical investigators in all fields an awareness of the tools required to ensure research protocols are well designed and comply with the rigorous regulatory requirements necessary to maximize the safety of research subjects. Complete with sections on the history of clinical research and ethics, copious figures and charts, and sample documents it serves as an excellent companion text for any course on clinical research and as a must-have reference for seasoned researchers. *Incorporates new chapters on Managing Conflicts of Interest in Human Subjects Research, Clinical Research from the Patient's Perspective, The Clinical Researcher and the Media, Data Management in Clinical Research, Evaluation of a Protocol Budget, Clinical Research from the Industry Perspective, and Genetics in Clinical Research *Addresses the vast opportunities for translation of basic science observations to the bedside through clinical research*Delves into data management and addresses how to collect data and use it for discovery*Contains valuable, up-to-date information on how to obtain funding from the federal government

Final Report of the Committee on a Strategic Plan for U.S. Burning Plasma Research

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Publisher : National Academies Press
ISBN 13 : 0309487439
Total Pages : 341 pages
Book Rating : 4.3/5 (94 download)

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Book Synopsis Final Report of the Committee on a Strategic Plan for U.S. Burning Plasma Research by : National Academies of Sciences, Engineering, and Medicine

Download or read book Final Report of the Committee on a Strategic Plan for U.S. Burning Plasma Research written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2019-07-01 with total page 341 pages. Available in PDF, EPUB and Kindle. Book excerpt: Fusion offers the prospect of virtually unlimited energy. The United States and many nations around the world have made enormous progress toward achieving fusion energy. With ITER scheduled to go online within a decade and demonstrate controlled fusion ten years later, now is the right time for the United States to develop plans to benefit from its investment in burning plasma research and take steps to develop fusion electricity for the nation's future energy needs. At the request of the Department of Energy, the National Academies of Sciences, Engineering, and Medicine organized a committee to develop a strategic plan for U.S. fusion research. The final report's two main recommendations are: (1) The United States should remain an ITER partner as the most cost-effective way to gain experience with a burning plasma at the scale of a power plant. (2) The United States should start a national program of accompanying research and technology leading to the construction of a compact pilot plant that produces electricity from fusion at the lowest possible capital cost.

The Belmont Report

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Publisher :
ISBN 13 :
Total Pages : 614 pages
Book Rating : 4.:/5 (327 download)

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Book Synopsis The Belmont Report by : United States. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research

Download or read book The Belmont Report written by United States. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research and published by . This book was released on 1978 with total page 614 pages. Available in PDF, EPUB and Kindle. Book excerpt:

The Prevention and Treatment of Missing Data in Clinical Trials

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Publisher : National Academies Press
ISBN 13 : 030918651X
Total Pages : 163 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis The Prevention and Treatment of Missing Data in Clinical Trials by : National Research Council

Download or read book The Prevention and Treatment of Missing Data in Clinical Trials written by National Research Council and published by National Academies Press. This book was released on 2010-12-21 with total page 163 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

NPR-A 105(c) Final Study

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Publisher :
ISBN 13 :
Total Pages : 538 pages
Book Rating : 4.:/5 (89 download)

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Book Synopsis NPR-A 105(c) Final Study by : National Petroleum Reserve in Alaska Task Force (U.S.)

Download or read book NPR-A 105(c) Final Study written by National Petroleum Reserve in Alaska Task Force (U.S.) and published by . This book was released on 1979 with total page 538 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Finding What Works in Health Care

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Publisher : National Academies Press
ISBN 13 : 0309164257
Total Pages : 267 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Finding What Works in Health Care by : Institute of Medicine

Download or read book Finding What Works in Health Care written by Institute of Medicine and published by National Academies Press. This book was released on 2011-07-20 with total page 267 pages. Available in PDF, EPUB and Kindle. Book excerpt: Healthcare decision makers in search of reliable information that compares health interventions increasingly turn to systematic reviews for the best summary of the evidence. Systematic reviews identify, select, assess, and synthesize the findings of similar but separate studies, and can help clarify what is known and not known about the potential benefits and harms of drugs, devices, and other healthcare services. Systematic reviews can be helpful for clinicians who want to integrate research findings into their daily practices, for patients to make well-informed choices about their own care, for professional medical societies and other organizations that develop clinical practice guidelines. Too often systematic reviews are of uncertain or poor quality. There are no universally accepted standards for developing systematic reviews leading to variability in how conflicts of interest and biases are handled, how evidence is appraised, and the overall scientific rigor of the process. In Finding What Works in Health Care the Institute of Medicine (IOM) recommends 21 standards for developing high-quality systematic reviews of comparative effectiveness research. The standards address the entire systematic review process from the initial steps of formulating the topic and building the review team to producing a detailed final report that synthesizes what the evidence shows and where knowledge gaps remain. Finding What Works in Health Care also proposes a framework for improving the quality of the science underpinning systematic reviews. This book will serve as a vital resource for both sponsors and producers of systematic reviews of comparative effectiveness research.

Principles of Good Clinical Practice

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Publisher : Pharmaceutical Press
ISBN 13 : 0853697906
Total Pages : 273 pages
Book Rating : 4.8/5 (536 download)

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Book Synopsis Principles of Good Clinical Practice by : Michael J. McGraw

Download or read book Principles of Good Clinical Practice written by Michael J. McGraw and published by Pharmaceutical Press. This book was released on 2010 with total page 273 pages. Available in PDF, EPUB and Kindle. Book excerpt: Part of "RPS Pharmacy Business Administration Series", this book offers good clinical practice guidelines. It includes standards on how clinical trials should be conducted, provide assurance of safety and efficacy of various drugs and protect human rights.

Head Start Impact

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Publisher : Nova Novinka
ISBN 13 :
Total Pages : 314 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Head Start Impact by : Michael J. Puma

Download or read book Head Start Impact written by Michael J. Puma and published by Nova Novinka. This book was released on 2006 with total page 314 pages. Available in PDF, EPUB and Kindle. Book excerpt: Since its beginning in 1965 as a part of the War on Poverty, Head Start's goal has been to boost the school readiness of low-income children. Based on a 'whole child' model, the program provides comprehensive services that include pre-school education; medical, dental, and mental health care; nutrition services; and efforts to help parents foster their child's development. Head Start services are designed to be responsive to each child's and family's ethnic, cultural, and linguistic heritage. The Congressionally-mandated Head Start Impact Study was conducted across 84 nationally representative grantee/delegate agencies. Approximately 5,000 newly entering 3- and 4-year-old children applying for Head Start were randomly assigned to either a Head Start group that had access to Head Start program services or to a non- Head Start group that could enrol in available community non-Head Start services, selected by their parents. Data collection began in fall 2002 and is scheduled to continue through 2006, following children through the spring of their 1st-grade year. The study quantifies the impact of Head Start separately for 3- and 4-year-old children across child cognitive, social-emotional, and health domains as well as ii on parenting practices. This book is essential reading for those in the education field.

Final Review of the Study on Supplemental Treatment Approaches of Low-Activity Waste at the Hanford Nuclear Reservation

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Publisher : National Academies Press
ISBN 13 : 0309672880
Total Pages : 131 pages
Book Rating : 4.3/5 (96 download)

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Book Synopsis Final Review of the Study on Supplemental Treatment Approaches of Low-Activity Waste at the Hanford Nuclear Reservation by : National Academies of Sciences, Engineering, and Medicine

Download or read book Final Review of the Study on Supplemental Treatment Approaches of Low-Activity Waste at the Hanford Nuclear Reservation written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2020-04-30 with total page 131 pages. Available in PDF, EPUB and Kindle. Book excerpt: The U.S. Department of Energy's Office of Environmental Management is responsible for managing and cleaning up the waste and contamination at the Hanford Nuclear Reservation, the nation's biggest and most complex nuclear cleanup challenge. At the site, 177 underground tanks collectively contain about 211 million liters of waste that includes high-activity and low-activity materials. At the request of Congress, Final Review of the Study on Supplemental Treatment Approaches of Low-Activity Waste at the Hanford Nuclear Reservation: Review #4 focuses on approaches for treatment and disposal of the supplemental portion of the low-activity waste from the tanks. This review report discusses developments since the publication of Review #3 and provides a summary of public comments on the third committee review report. The authoring committee then shares their views on these comments and whether they change any of the findings or recommendations in the third review report.

Technical Reports of the National Highway Traffic Safety Administration

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Publisher :
ISBN 13 :
Total Pages : 360 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Technical Reports of the National Highway Traffic Safety Administration by : United States. National Highway Traffic Safety Administration. Office of Administrative Services

Download or read book Technical Reports of the National Highway Traffic Safety Administration written by United States. National Highway Traffic Safety Administration. Office of Administrative Services and published by . This book was released on 1973 with total page 360 pages. Available in PDF, EPUB and Kindle. Book excerpt:

The Iraq Study Group Report

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Publisher : Vintage
ISBN 13 :
Total Pages : 164 pages
Book Rating : 4.:/5 (319 download)

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Book Synopsis The Iraq Study Group Report by : Iraq Study Group (U.S.)

Download or read book The Iraq Study Group Report written by Iraq Study Group (U.S.) and published by Vintage. This book was released on 2006-12-06 with total page 164 pages. Available in PDF, EPUB and Kindle. Book excerpt: Presents the findings of the bipartisan Iraq Study Group, which was formed in 2006 to examine the situation in Iraq and offer suggestions for the American military's future involvement in the region.

Departmental Self-study Report

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Publisher :
ISBN 13 :
Total Pages : pages
Book Rating : 4.:/5 (13 download)

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Book Synopsis Departmental Self-study Report by : David Lipscomb College

Download or read book Departmental Self-study Report written by David Lipscomb College and published by . This book was released on 1984 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:

Scientific and Technical Aerospace Reports

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Publisher :
ISBN 13 :
Total Pages : 1456 pages
Book Rating : 4.3/5 (243 download)

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Book Synopsis Scientific and Technical Aerospace Reports by :

Download or read book Scientific and Technical Aerospace Reports written by and published by . This book was released on 1966 with total page 1456 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Workplace Wellness Programs Study

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Publisher : Rand Corporation
ISBN 13 : 9780833080738
Total Pages : 0 pages
Book Rating : 4.0/5 (87 download)

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Book Synopsis Workplace Wellness Programs Study by : Soeren Mattke

Download or read book Workplace Wellness Programs Study written by Soeren Mattke and published by Rand Corporation. This book was released on 2013 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: The report investigates the characteristics of workplace wellness programs, their prevalence and impact on employee health and medical cost, facilitators of their success, and the role of incentives in such programs. The authors employ four data collection and analysis streams: a literature review, a survey of employers, a longitudinal analysis of medical claims and wellness program data from a sample of employers, and five employer case studies.