and, in the case of the British Medical Journal (BMJ), to agree to make de-identified patient-level data available upon “reasonable request” as a condition for publication (Godlee and Groves, 2012, p. 1).

In October 2012, the Institute of Medicine (IOM) convened individuals with a broad range of expertise and perspectives to discuss sharing of clinical research data in a public workshop. As highlighted by workshop participants, data sharing can provide important potential benefits to industry, nonprofit and government funders of research, academic investigators, patient advocacy groups, and, ultimately, patients and the public, including, for example, speeding medical innovation by reducing redundancies, facilitating the identification and validation of new drug targets, identifying new indications for use, and improving the understanding of the safety and efficacy of therapies (IOM, 2013). In followup to the 2012 IOM workshop, the IOM was asked by a group of federal, industry, and U.S. and international foundation sponsors3 to conduct a consensus study to recommend guiding principles and a framework for the responsible sharing of clinical trial data.

Charge to the Committee and Scope of the Study

As described in the committee’s charge from the sponsors (see Appendix A), over a 17-month period of deliberations, the committee will release two documents:

1.   This document, which is a framework for discussion (“framework”), to be released in January 2014 for public comment. The framework will summarize the committee’s initial thoughts on guiding principles that underpin responsible sharing of clinical trial data, define key elements of clinical trial data and data sharing, and describe a selected set of clinical trial data sharing activities. The charge to the committee excludes evidence-based findings and conclusions and recommendations from this document.

2.   A final report with findings and recommendations related to the committee’s full charge.

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3 U.S. 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 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 Wellcome Trust.



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