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

Abstract

AU Clinical: Pleaseconfirmthatallheadinglevelsarerepresentedcorrectly 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.