Preparing for Responsible Sharing of Clinical Trial Data

Abstract

Data from clinical trials, including participant-level data, are being shared by sponsors and investigators more widely than ever before. Some sponsors have voluntarily offered data to researchers,^1,2 some journals now require authors to agree to share the data underlying the studies they publish,³ the Office of Science and Technology Policy has directed federal agencies to expand public access to data from federally funded projects,⁴ and the European Medicines Agency (EMA) and U.S. Food and Drug Administration (FDA) have proposed the expansion of access to data submitted in regulatory applications.^5,6 Sharing participant-level data may bring exciting benefits for scientific research and public health but may also have unintended consequences. Thus, expanded data sharing must be pursued thoughtfully.