Preparing for Responsible Sharing of Clinical Trial Data

The authors review the potential benefits and unintended consequences of the broad sharing of participant-level data from clinical trials. Several options for governance structures that could be implemented to provide expanded access to clinical trial data are discussed. 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 ...