The International Committee of Medical Journal Editors (ICMJE), which is comprised of various member journals including the New England Journal of Medicine (NEJM) and The Lancet, just published its highly anticipated data sharing requirements on June 6, 2017. These new requirements are subsequent to the ICMJE’s initial clinical trial data sharing proposal published in January 2016, which proposed that authors share deidentified individual patient data for results presented in the article no later than six months after publication. According to ICMJE, the initial proposal was met with “many comments from individuals and groups,” as part of their request for feedback, and “many raised valid concerns regarding the feasibility of the proposed requirements, the necessary resources, the real or perceived risks to trial participants, and the need to protect the interests of patients and researchers.”1
The newly published ICMJE data sharing requirements differ from the initial proposal. In particular, they do not include requirements for the sharing of deidentified individual patient data. ICMJE retained a requirement from the initial proposal for authors to include a plan for data sharing as a part of clinical trial registration, and added a requirement for authors to include a data sharing statement with the manuscript submission.
More specifically, ICMJE will require the following as conditions of consideration for publication of a clinical trial report in its member journals:
- As of July 1, 2018, manuscripts submitted to ICMJE journals that report the results of clinical trials must contain a data sharing statement.
- Clinical trials that begin enrolling participants on or after January 1, 2019, must include a data sharing plan in the trial’s registration. ICMJE’s policy regarding trial registration is explained here. If the data sharing plan changes after trial registration, this should be reflected in the statement submitted and published with the manuscript, and updated in the registry record.1
Data sharing statements will need to indicate:
- 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, etc.)
- When the data will become available and for how long
- By what access criteria data will be shared (including with whom, for what types of analyses, and by what mechanism)1
Examples of data sharing statements can be found in the ICMJE data sharing requirements.
Although the new requirements do not yet mandate data sharing, ICMJE states that investigators should be aware that editors may take into consideration data sharing statements when making editorial decisions. In addition, individual ICMJE member journals may already have, or may choose to adopt, more stringent requirements for data sharing.1
- Taichman DB, Sahni P, Pinborg A, Peiperl L, Laine C, James A, et al. Data Sharing Statements for Clinical Trials: A Requirement of the International Committee of Medical Journal Editors. Ann Intern Med. [Epub ahead of print 6 June 2017]:. doi: 10.7326/M17-1028