Sharing clinical trial data : maximizing benefits, minimizing risk / Committee on Strategies for Responsible Sharing of Clinical Trial Data, Board on Health Sciences Policy, Institute of Medicine of the National Academies.

Washington, D.C. : National Academies Press, [2015]

xiv, 290 pages : colour illustrations ; 23 cm

Includes bibliographical references.

Introduction -- Guiding principles for sharing clinical trial data -- The roles and responsibilities of stakeholders in the sharing of clinical trial data -- The clinical trial life cycle and when to share data -- Access to clinical trial data: governance -- The future of data sharing in a changing landscape -- Study approach -- Concepts and methods for de-identifying clinical trial data -- Legal discussion of risks to industry sponsors -- Clinical trial data sharing policies: top 12 pharmaceutical companies ranked by 2013 market capitalization.

This study was supported by contracts between the National Academy of Sciences and the U.S. National Institutes of Health (HHSN263201200074I), U.S. Food and Drug Administration, AbbVie Inc., Amgen Inc., AstraZeneca Pharmaceuticals, Bayer, Biogen Idec, Bristol-Myers Squibb, Burroughs Wellcome Fund, Doris Duke Charitable Foundation, Eli Lilly and Company, EMD Serono, Genentech, GlaxoSmithKline, Johnson & Johnson, Medical Research Council (UK), Merck & Co., Inc., Novartis Pharmaceuticals Corporation, Novo Nordisk, Pfizer Inc., Sanofi-Aventis, Takeda, and The Wellcome Trust. Any opinions, findings, conclusions, or recommendations expressed in this publication are those of the author(s) and do not necessarily reflect the views of the organizations or agencies that provided support for the project.