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ICMJE announce new data sharing requirements for publication of clinical trial reports

In recent years, the International Committee of Medical Journal Editors (ICMJE) has been striving to make widespread data sharing the norm. In January 2016, the committee published a proposal to require authors to share deidentified individual patient data underlying results presented in articles reporting clinical trials within six months of publication. This proposal was met with a positive reaction from many who support the commitment to data sharing, but also concern over the feasibility of the endeavour.

This week the ICMJE appear to have backed off mandating data sharing but have set out minimum requirements for publication of clinical trial reports in ICMJE member journals, which include The Lancet and The British Medical Journal among them.

As of 1 July 2018, manuscripts submitted to ICMJE journals reporting clinical trial data must contain a data sharing statement, indicating:

  • whether the authors intend to share individual deidentified participant data
  • what specific data they intend to share
  • what other study-related documents will be made available
  • how the data will be accessible
  • when and for how long they will be made available.

The statement may then be taken into account by ICMJE editors when considering the paper for publication. Furthermore, clinical trials that begin enrolling participants on or after 1 January 2019 must include a data sharing plan in the trial’s registration if they wish to publish results in ICMJE journals. Any deviations from this plan must be disclosed in the data sharing statement when published.

ICMJE believe that scientists have a moral obligation to share clinical data to maximise the knowledge obtained from these research efforts. The committee is working with a number of groups to solve the various practical issues that they acknowledge still exist to in order to achieve their goal of universal data sharing.

ICMJE data sharing

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Summary by Alice Wareham, PhD from Aspire Scientific

Aspire Scientific Ltd View All

Ryan co-runs Aspire Scientific, a dynamic, forward-thinking medical writing agency. Ryan has a passion for innovation, science and ethical communication.

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