Ten (not so) simple rules for clinical trial data-sharing

by Claude Pellen, Anne Le Louarn, Gilliosa Spurrier-Bernard, Evelyne Decullier, Jean-Marie Chrétien, Eric Rosenthal, Gérard Le Goff, David Moher, John P. A. Ioannidis, Florian Naudet

Clinical trial data-sharing is seen as an imperative for research integrity and is becoming increasingly encouraged or even required by funders, journals, and other stakeholders. However, early experiences with data-sharing have been disappointing because they are not always conducted properly. Health data is indeed sensitive and not always easy to share in a responsible way. We propose 10 rules for researchers wishing to share their data. These rules cover the majority of elements to be considered in order to start the commendable process of clinical trial data-sharing: Rule 1: Abide by local legal and regulatory data protection requirements Rule 2: Anticipate the possibility of clinical trial data-sharing before obtaining funding Rule 3: Declare your intent to share data in the registration step Rule 4: Involve research participants Rule 5: Determine the method of data access Rule 6: Remember there are several other elements to share Rule 7: Do not proceed alone Rule 8: Deploy optimal data management to ensure that the data shared is useful Rule 9: Minimize risks Rule 10: Strive for excellence.