Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk


Clinical trials play a crucial role in advancing medical innovation and represent a significant investment from all involved — including trial participants, sponsors, and researchers. Data are generated throughout the clinical trial lifecycle, but results are often not published in a timely manner, and many data are not shared beyond the original investigators.

Data sharing could advance scientific discovery and improve clinical care by maximizing knowledge gained from data collected in trials, stimulating new ideas for research, and avoiding unnecessarily duplicative trials; however, to reduce potential harms, policies are needed to protect the privacy and consent of participants, the validity of analyses, the investment of funders and sponsors, and the academic recognition of investigators.

To answer this need, an Institute of Medicine consensus study recommends guiding principles and a practical framework to enhance clinical trial data sharing, the practice of making data from scientific research available—with or without restrictions—for secondary uses, which include re-analyses, new de novo analyses and meta-analyses. This infographic focuses exclusively on the committee’s recommendation for when to share data.

What data should be shared and when during the clinical trial lifecycle in order to help amplify scientific knowledge worldwide while minimizing risk?