Rafael Dal-Ré and colleagues discuss the challenges of new requirements for sharing individual participant data from US federally funded trials conducted in other countries in a recent publication. Despite previous discussions on the transparency of clinical trials, sharing of de-identified individual participant data remains uncommon. However, two new US regulations aim to increase sharing of such data, with the National Institutes of Health (NIH) enforcing a policy for data management and sharing from January 2023, and the White House Office of Science and Technology Policy requiring data from all federally funded research to be freely accessible upon publication by no later than December 2025. These requirements are expected to impact global research practices, particularly in low and middle income countries.
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Navigating US participant data sharing requirements: implications for international clinical trials
