CTU Bern (Clinical Trials Unit)

Clinical data sharing: new requirements published by the ICMJE

In January 2016, the International Committee of Medical Journal Editors ICMJE released a first proposal regarding data sharing. Its aim was to set the foundation for the creation of an environment in which the sharing of deidentified individual participant data becomes standard.

The feedback and replies to the proposal have shown that there are still many (and substantial) issues, which need addressing before data sharing becomes the norm. However, the ICMJE believes that there is an ethical obligation to responsibly share clinical trial data: participants of interventional trials put themselves at risk. The Committee therefore remains committed to its original goal. On June 5th 2017, new data sharing requirements were published by the ICMJE. The requirements, as listed below, will become conditions for the consideration for publication of clinical trial reports in their member journals:

1. As of July 1, 2018, manuscripts submitted to ICMJE journals that report the results of clinical trials must contain a data sharing statement. The data sharing statement must indicate the following:
  • whether individual deidentified participant data (including data dictionaries) will be shared;
  • what data in particular will be shared;
  • whether additional, related documents will be available (eg, study protocol, statistical analysis plan);
  • when the data will become available and for how long;
  • and by what access criteria data will be shared (including with whom, for what types of analyses, and by what mechanism).

A table of exemplary data sharing statements that fulfill the ICMJE's requirements can be found here.

2. Clinical trials that begin enrolling participants on or after January 1, 2019, must include a data sharing plan in the trial’s registration. The ICMJE’s policy regarding trial registration is explained at http://www.icmje.org/recommendations/browse/publishing-and-editorial-issues/clinical-trial-registration.html. If the data sharing plan changes after registration this should be reflected in the statement submitted and published with the manuscript and updated in the registry record.

 

These initial and minimum requirements are intended to move the research enterprise closer to fulfilling its ethical obligation to participants. They do not (yet) mandate data sharing, but investigators should be aware that editors may take into consideration data sharing statements when making editorial decisions. Some ICMJE member journals already maintain, or may choose to adopt, more stringent requirements for data sharing.

Specific elements to enable data sharing statements that meet these requirements have also been adopted at ClinicalTrials.gov (https://prsinfo.clinicaltrials.gov/definitions.html#shareData).

The ICMJE invites investigators and organization to share their creative solutions to issues that are yet unsolved, including the appropriate scholarly credit to those who share data, resources needed for data access, transparent processing of data requests, and data archiving.

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