Data sharing enables de-identified participant-level results from clinical trials to be made available and effectively re-used by other members of the scientific community and researchers. The practice of data sharing is underpinned by the ethical obligation of researchers to optimise and make full use of a participant’s contribution to clinical research. The main objective of these secondary analyses should be to improve patient outcomes and add to the current knowledge base while protecting patient confidentiality.
In 2018 the International Committee of Medical Journal Editors (ICMJE) published guidelines on the requirements for data sharing in clinical trials. The newly established rules centred around two key factors;
- All manuscripts submitted from 01 July 2018 reporting the results of a clinical trial must contain a data sharing statement covering the following ICMJE requirements:
- Whether individual de-identified participant data will be shared
- What data will be shared (e.g. individual de-identified data collected during trial, de-identified data underlying reported results such as tables/figures/texts/appendices)
- What other documents will be made available (e.g. study protocol, statistical analysis plan)
- When will the data become available and for how long
- With whom can the data be shared
- What type of analyses can the data be used for
- The mechanism by which the data will be made available (e.g. direct link to data, data can be requested from authors or by submission of proposal)
An example of a data sharing statement from the PRACTICAL trial published in the Lancet is as follows:
“De-identified individual participant data collected during the PRACTICAL trial will be shared at 2 years after article publication with no end date. These data will be available to researchers who provide a methodologically sound proposal for the purposes of achieving specific aims outlined in that proposal. Proposals should be directed to [name] via email ([email]) and will be reviewed by the PRACTICAL study management committee. Requests to access data to undertake hypothesis-driven research will not be unreasonably withheld. To gain access, data requesters will need to sign a data access agreement and to confirm that data will only be used for the agreed purpose for which access was granted.”
- Clinical trials enrolling participants on or after 01 January 2019 will need to include a data sharing plan as part of their trial registration.
Clinicaltrials.gov and WHO International Clinical Trials Registry Platform (ICTRP) both now outline the elements that should be included in the individual participant data sharing plan as part of the trial registration process. (Clinicaltrials.gov here; ICTRP here)