Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk

Institute of Medicine

A report commissioned by NIH and other sponsors on promoting responsible access to participant level data.

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Sharing Clinical Trial Data — A Proposal from the International Committee of Medical Journal Editor

International Committee of Medical Journal Editors
Jan. 2016

A proposal from the editors of major medical journals across the world to make publication in their journals contingent on sharing de-identified, individual-level participant data from clinical trials with other researchers under certain parameters.

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NIH Data Sharing Policy

National Institutes of Health

This site includes the NIH Statement on Sharing Research Data (2003), Data Sharing Regulations for NIH Awards, and other information on the NIH data sharing policy.

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Principles for Responsible Clinical Trial Data Sharing

Jul. 2013

A joint agreement produced by pharmaceutical trade groups PhRMA and EFPIA, affirming the industry’s commitment to responsible data sharing.

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Clinical Trial Data Portal Gateway


This site offers a published list of major pharmaceutical companies’ online portals aimed at advancing responsible clinical trial data sharing.

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Sharing of Clinical Trials Data: Benefits, Risks, and Uniform Principles

Annals of Internal Medicine
Michael Rosenblatt et al.

This commentary discusses the benefits and risks of data sharing from the perspective of persons with experience in academic medicine, government, and medical publishing, as well as the pharmaceutical industry.

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Sharing and Reporting the Results of Clinical Trials

Jan. 2015
Kathy L. Hudson and Francis S. Collins

This article advocates for sharing the results of clinical trials as an important means for advancing medical knowledge and promoting health.

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Preparing for Responsible Sharing of Clinical Trial Data

New England Journal of Medicine
Oct. 2013
Michelle M. Mello et al.

As more patient data from clinical trials is shared by sponsors and investigators, this article provides a suggested framework for broad sharing of participant-level data from clinical trials and related technical documents.

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Technical and Policy Approaches to Balancing Patient Privacy and Data Sharing

Journal of Investigative Medicine
Jan. 2010
Bradley Malin et al.

This paper reviews several aspects of the privacy-related problems associated with data sharing for clinical research from technical and policy perspectives.

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Yale University Open Data Access Project

Yale School of Medicine

The YODA project has iteratively developed a model to make data available to researchers in a sustainable way; the project currently has 123 trials available to request.

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Data Sharing and Transparency Initiative

Multi-Regional Clinical Trials Center

A data sharing and transparency initiative aimed at facilitating broad stakeholder clinical trials data sharing.

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