ICMJE updates data sharing policy for clinical trials
The International Committee of Medical Journal Editors (ICMJE) would like to see clinical trials sharing deidentified individual participant data, but recognizes this may be challenging in many settings. Therefore, the current version of the upcoming policy will not specifically require sharing data, but will require a statement of the data sharing plan.
The policy will become effective July 1, 2018 and will mandate that clinical trials that begin enrolling participants on or after January 1, 2019 must include a data sharing plan in the trial's clinicaltrials.gov registration.
The data sharing statement must indicate:
- Whether individual deidentified participant data will be shared
- What data in particular will be shared
- Whether additional, related documents will be available
- When the data will become available and for how long
- How the data will be accessible
While these requirements do not yet mandate data sharing, investigators should be aware that editors reviewing reports for publication may take into consideration the data sharing agreement.
For a list of journals following the ICMJE recommendations, visit icmje.org.
The full editorial is available if you would like more information.