Sharing Clinical Trial Data

Sharing Clinical Trial Data

Author: Institute of Medicine

Publisher: National Academies Press

Published: 2015-04-20

Total Pages: 236

ISBN-13: 0309316324

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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.


Advancing Human Assessment

Advancing Human Assessment

Author: Randy E. Bennett

Publisher: Springer

Published: 2017-10-17

Total Pages: 717

ISBN-13: 3319586890

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This book is open access under a CC BY-NC 2.5 license.​​ This book describes the extensive contributions made toward the advancement of human assessment by scientists from one of the world’s leading research institutions, Educational Testing Service. The book’s four major sections detail research and development in measurement and statistics, education policy analysis and evaluation, scientific psychology, and validity. Many of the developments presented have become de-facto standards in educational and psychological measurement, including in item response theory (IRT), linking and equating, differential item functioning (DIF), and educational surveys like the National Assessment of Educational Progress (NAEP), the Programme of international Student Assessment (PISA), the Progress of International Reading Literacy Study (PIRLS) and the Trends in Mathematics and Science Study (TIMSS). In addition to its comprehensive coverage of contributions to the theory and methodology of educational and psychological measurement and statistics, the book gives significant attention to ETS work in cognitive, personality, developmental, and social psychology, and to education policy analysis and program evaluation. The chapter authors are long-standing experts who provide broad coverage and thoughtful insights that build upon decades of experience in research and best practices for measurement, evaluation, scientific psychology, and education policy analysis. Opening with a chapter on the genesis of ETS and closing with a synthesis of the enormously diverse set of contributions made over its 70-year history, the book is a useful resource for all interested in the improvement of human assessment.


Thoracic Tumours

Thoracic Tumours

Author: W. H. O. Classification WHO Classification of Tumours Editorial Board

Publisher:

Published: 2021-04-21

Total Pages: 500

ISBN-13: 9789283245063

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****When not purchasing directly from the official sales agents of the WHO, especially at online bookshops, please note that there have been issues with counterfeited copies. Buy only from known sellers and if there are quality issues, please contact the seller for a refund.***** Thoracic Tumoursis the fifth available volume in the fifth edition of the WHO series on the classification of human tumours. This series (also known as the WHO Blue Books) is regarded as the gold standard for the diagnosis of tumours and comprises a unique synthesis of histopathological diagnosis with digital and molecular pathology. These authoritative and concise reference books provide indispensable international standards for anyone involved in the care of patients with cancer or in cancer research, underpinning individual patient treatment as well as research into all aspects of cancer causation, prevention, therapy, and education. What's new in this edition? The fifth edition, guided by the WHO Classification of Tumours Editorial Board, establishes a single coherent cancer classification presented across a collection of individual volumes organized on the basis of anatomical site (digestive system, breast, soft tissue and bone, etc.) and structured in a systematic manner, with each tumour type listed within a taxonomic classification: site, category, family (class), type, and subtype. In each volume, the entities are now listed from benign to malignant and are described under an updated set of headings, including histopathology, diagnostic molecular pathology, staging, and easy-to-read essential and desirable diagnostic criteria. Who should read this book? * Pathologists * Oncologists * Respiratory physicians * Thoracic radiologists * Cancer researchers * Surgeons * Epidemiologists * Cancer registrars This volume: * Prepared by 217 authors and editors * Contributors from around the world * More than 1000 high-quality images * More than 3500 references


The Prevention and Treatment of Missing Data in Clinical Trials

The Prevention and Treatment of Missing Data in Clinical Trials

Author: National Research Council

Publisher: National Academies Press

Published: 2010-12-21

Total Pages: 163

ISBN-13: 030918651X

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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.


Reporting Research in Psychology

Reporting Research in Psychology

Author: Harris M. Cooper

Publisher: American Psychological Association (APA)

Published: 2011

Total Pages: 156

ISBN-13:

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"An educational guide based on the Publication manual of the American Psychological Association"--Cover.


Beyond the HIPAA Privacy Rule

Beyond the HIPAA Privacy Rule

Author: Institute of Medicine

Publisher: National Academies Press

Published: 2009-03-24

Total Pages: 334

ISBN-13: 0309124999

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In the realm of health care, privacy protections are needed to preserve patients' dignity and prevent possible harms. Ten years ago, to address these concerns as well as set guidelines for ethical health research, Congress called for a set of federal standards now known as the HIPAA Privacy Rule. In its 2009 report, Beyond the HIPAA Privacy Rule: Enhancing Privacy, Improving Health Through Research, the Institute of Medicine's Committee on Health Research and the Privacy of Health Information concludes that the HIPAA Privacy Rule does not protect privacy as well as it should, and that it impedes important health research.


Current Catalog

Current Catalog

Author: National Library of Medicine (U.S.)

Publisher:

Published:

Total Pages: 1568

ISBN-13:

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First multi-year cumulation covers six years: 1965-70.