The article has been published in the PLOS Computational Biology journal and provides a set of rules for the clinical trial data sharing process. 

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

Claude Pellen (Université de Rennes/CHU de Rennes)
Anne Le Louarn (CNCR)
Gilliosa Spurrier (Melanome France)
Evelyne Decullier (HCL)
Jean-Marie Chrétien (CHU Angers)
Eric Rosenthal (ANRS|MIE)
Gerard Le Goff (France Rein Bretagne)
Florian Naudet (Université de Rennes/CHU de Rennes)


David Mother ( Ottawa Hospital Research Institute, Canada)
John P.A. Ioannidis ( Stanford University, United States of America)

March 2023

Sharing clinical trial data is considered essential for research integrity and is increasingly encouraged and often actually demanded by funding bodies, journals and other stakeholders. However, early experiences of data sharing have been disappointing because this is not always properly conducted.
Health data are sensitive which means it is not always easy to share them responsibly so these ten rules are intended to help researchers who wish to do so. These rules cover most of the elements to be considered when starting the process of sharing clinical trial data:

  • 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.