A vast amount of valuable scientific data coming out of clinical trials around the world is being lost. This information is often not published and not made available to other researchers. Sharing this data could significantly advance medical research, quicken the pace of scientific discovery, speed innovation of new therapies, and make enormous strides toward improving clinical care. Those are some of the conclusions of a multi-year study by the Institute of Medicine (IOM), Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk.

Guiding Principles for a New Framework

The report was compiled by a committee of experts assembled by the IOM’s Board on Health Science Policy with support from 23 sponsors in the United States and around the world. The committee was charged with developing guidance and a practical framework for the responsible sharing of clinical trial data.

The report concludes that carefully controlled data-sharing would provide greater scientific knowledge and better therapies for patients and that these benefits had to be balanced against violation of privacy risks, inappropriate use of raw data, and conflicting stakeholder priorities.

The committee agreed on four guiding principles to construct a responsible overall framework that takes these goals into consideration

  1. Maximize the benefits of clinical trials while minimizing the risks of data sharing.
  2. Respect individual participants whose data are shared
  3. Increase public trust in clinical trials and the sharing of trial data.
  4. Conduct the sharing of trial data fairly.

Recommendations for Sharing Clinical Trial Data

Based on these guiding principles, the IOM committee provides a series of recommendations designed to develop the necessary culture, infrastructure, and policies for sharing of clinical trial data:

  1. Stakeholders in clinical trials should foster a culture in which data sharing is the expected norm, and should commit to responsible strategies aimed at maximizing the benefits, minimizing the risks, and overcoming the challenges of sharing clinical trial data for all parties.
  2. Sponsors and investigators should share the various types of clinical trial data no later than the times specified below. Sponsors and investigators who decide to make data available for sharing before these times are encouraged to do so.
  3. Holders of clinical trial data should mitigate the risks and enhance the benefits of sharing sensitive clinical trial data by implementing operational strategies that include employing data use agreements, designating an independent review panel, including members of the lay public in governance, and making access to clinical trial data transparent.
  4. The sponsors of this study should take the lead, together with or via a trusted impartial organization(s), to convene a multi-stakeholder body with global reach and broad representation to address, in an ongoing process, the key infrastructure, technological, sustainability, and workforce challenges associated with the sharing of clinical trial data.

For each of these high-level recommendations, the report provides specific action items for funders and sponsors of clinical trials, disease advocacy organizations, regulatory and research oversight bodies, investigators, clinical research organizations and universities, research ethics committees and institutional review boards (IRBs), peer-reviewed journals, and professional societies.

Categories of Sharable Data from Clinical Trials

Valuable data created during the course of a clinical trial would include the trial protocol, the plan for statistical analysis of results, and trial-specific analytic codes. Public summaries and clinical study overviews would also be a part of this. Key figures from the report detail the kind of information that could be shared, and when this sharing should happen.  To help readers visualize the process, the IOM provides excellent infographics.

Committee Members

The study committee members were:

  • Bernard Lo, MD, president of The Greenwall Foundation (Chair)
  • Timothy Coetzee, PhD, chief research officer of the National Multiple Sclerosis Society.
  • David L. DeMets, PhD, is currently Professor and Chair of the Department of Biostatistics and Medical Informatics at the University of Wisconsin – Madison.
  • Jeffrey M. Drazen, MD, editor-in-chief at the New England Journal of Medicine (NEJM).
  • Steven N. Goodman, MD, PhD, associate dean at Stanford University School of Medicine.
  • Patricia A. King, JD, professor of law, medicine, and public policy at Georgetown University.
  • Trudie Lang, PhD, investigator at the University of Oxford Centre for Tropical Medicine.
  • Deven McGraw, JD, LLM, MPH, partner at Manatt, Phelps & Phillips, LLP, and former Director of the Health Privacy Project at the Center for Democracy & Technology.
  • Elizabeth Nabel, MD, president of Brigham and Women’s Hospital (BWH) and professor of medicine at Harvard Medical School.
  • Elvin R. Latty, JD, professor of law at the Duke University School of Law.
  • Ida Sim, MD, PhD, professor of medicine at the University of California, San Francisco (USCF) School of Medicine.
  • Sharon Terry, MA, president and CEO of Genetic Alliance.
  • Joanne Waldstreicher, MD, chief medical officer at Johnson and Johnson.

Learn More

The full report – Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk – is available free online in PDF and for purchase in print.  The IOM site also provides:

Information on Strategies for Responsible Sharing of Clinical Trial Data, the IOM study project that resulted in the report, including webcasts of meetings, is available here.