Date:  Jan. 22, 2014




IOM Solicits Public Input for Study on Responsible Sharing of Data From Clinical Trials


WASHINGTON – The Institute of Medicine has released a “discussion framework” to solicit input for a study on how to share data from clinical trials responsibly. The framework provides preliminary guiding principles, defines and describes selected data and data-sharing activities, and poses key questions to solicit input from researchers, clinical trial sponsors, patients, advocacy groups, other stakeholders, and the public.  Responses will be used to help inform the committee's final report.


Clinical trials of medical interventions such as drugs, medical devices, procedures, and behavioral interventions generate vast amounts of data, which might be shared confidentially with government regulatory agencies or other parties but are not routinely available to other researchers or the public.  Sharing these data more broadly -- while respecting research participants and their privacy -- could facilitate new analyses, provide a deeper understanding of therapies, and ultimately provide a sounder basis for clinical care. European regulators, pharmaceutical companies, and some researchers are currently adopting policies to share data from clinical trials.


Rather than point to findings or recommendations, the framework presents the committee’s preliminary guiding principles for data sharing.  They include respecting the individual clinical trial participants whose data are shared, maximizing benefits to research participants and to society while minimizing harm, increasing public trust in clinical trials, and sharing data in a manner that enhances fairness.  The committee also identifies key elements of data and data sharing activities that it will examine during the course of the study, including what data might be shared, who provides or receives shared data, and whether access to data will be controlled. The committee’s observations are preliminary and not intended to be comprehensive; members of the public are invited to point out omissions, suggest changes, and help identify the potential benefits, risks, and challenges of data-sharing options.


Comments may be submitted to the committee at either of two public workshops, to be held Feb. 3-4 and May 5 in Washington, DC, or via the committee’s project website, Comments will be most useful if submitted by March 24, 2014.  The committee expects to release its final report with findings and recommendations on strategies and practical approaches to responsible data sharing in late 2014.


The study is funded by the National Institutes of Health, 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 Co., EMD Serono, Genentech, GlaxoSmithKline, Johnson & Johnson, Medical Research Council (UK), Merck & Co. Inc., Novartis Pharmaceuticals Corp., Novo Nordisk, Pfizer Inc., Sanofi-Aventis, Takeda, and The Wellcome Trust.


Established in 1970 under the charter of the National Academy of Sciences, the Institute of Medicine provides independent, objective, evidence-based, peer-reviewed advice to policymakers, health professionals, the private sector, and the public.  The National Academy of Sciences, National Academy of Engineering, Institute of Medicine, and National Research Council make up the National Academies.   A committee roster follows.



Molly Galvin, Senior Media Relations Officer

Rachel Brody, Media Relations Associate

Office of News and Public Information

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Copies of Discussion Framework for Clinical Trial Data Sharing: Guiding Principles, Elements, and Activities are available from the National Academies Press on the Internet at or by calling tel. 202-334-3313 or 1-800-624-6242.  Reporters may obtain a copy from the Office of News and Public Information (contacts listed above).


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Board on Health Sciences Policy


Committee on Strategies for Responsible Sharing of Clinical Trial Data


Bernard Lo, M.D. (chair)


The Greenwall Foundation

New York City


Timothy Coetzee, Ph.D.

Chief Research Officer

National Multiple Sclerosis Society

New York City


David DeMets, Ph.D., M.S.

Professor and Chair

Department of Biostatistics and Medical Informatics

University of Wisconsin



Jeffrey Drazen, M.D.


New England Journal of Medicine



Steven Goodman, Ph.D., M.D.


Medicine & Health Research & Policy

Stanford University School of Medicine

Stanford, Calif.


Patricia King, J.D.

Carmack Waterhouse Professor

Law, Medicine, Ethics and Public Policy

Georgetown University Law Center

Washington, D.C.


Trudie Lang, Ph.D.

Principal Investigator

Global Health Network

Nuffield Department of Medicine

University of Oxford

United Kingdom


Deven McGraw, J.D., M.Ph.

Director, Health Privacy Project

Center for Democracy & Technology

Washington, D.C.


Elizabeth Nabel, M.D.


Brigham and Women’s Hospital



Arti Rai, J.D.

Elvin R. Latty Professor of Law

Duke University School of Law

Durham, N.C.


Ida Sim, M.D., Ph.D.

Associate Professor of Medicine


Biomedical Informatics of the Clinical and Translational Science Institute

University of California at San Francisco


Sharon Terry, M.A.

President and CEO

Genetic Alliance

Washington, D.C.


Joanne Waldstreicher, M.D.

Chief Medical Officer

Johnson & Johnson

New Brunswick, N.J