Title Discussion framework for clinical trial data sharing : guiding principles, elements, and activities / Committee on Strategies for Responsible Sharing of Clinical Trial Data, Board on Health Sciences Policy, Institute of Medicine of the National Academies

Published Washington, D.C. : National Academies Press, 2014 ©2014

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Description 1 online resource (72 pages) : 1 color illustration Series Online access: NCBI NCBI Bookshelf Contents FrontMatter -- Reviewers -- Preface -- Contents -- Boxes and Figure -- Discussion Framework for Clinical Trial Data Sharing -- References -- Appendix A: Statement of Task -- Appendix B: Committee Biographies -- Appendix C: Figure 1: Data Flow from Participant to Analyzed Data and Reporting Summary "Sharing data generated through the conduct of clinical trials offers the promise of placing evidence about the safety and efficacy of therapies and clinical interventions on a firmer basis and enhancing the benefits of clinical trials. Ultimately, such data sharing--if carried out appropriately--could lead to improved clinical care and greater public trust in clinical research and health care. Discussion Framework for Clinical Trial Data Sharing: Guiding Principles, Elements, and Activities is part of a study of how data from clinical trials might best be shared. This document is designed as a framework for discussion and public comment. This framework is being released to stimulate reactions and comments from stakeholders and the public. The framework summarizes the committee's initial thoughts on guiding principles that underpin responsible sharing of clinical trial data, defines key elements of clinical trial data and data sharing, and describes a selected set of clinical trial data sharing activities."--Publisher's website Bibliography Includes bibliographical references Subject Clinical trials -- United States Drugs -- United States -- Testing Medicine -- United States -- Data processing Drugs. Freedom of information. International cooperation. Clinical Trials as Topic Pharmaceutical Preparations Information Dissemination Access to Information International Cooperation MEDICAL -- Pharmacology. International cooperation Freedom of information Drugs Clinical trials Drugs -- Testing Medicine -- Data processing United States Form Electronic book ISBN 9780309297806 030929780X

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