New clinical trial data sharing requirements for publications: comment period opens

The International Committee of Medical Journal Editors (ICMJE) is proposing changes in clinical trial data sharing requirements for publishing. The new rules would require investigators to include data sharing plans, and share de-identified data. The ICMJE is currently accepting feedback through their website (www.icmje.org). Changes will go into effect one year after formal adoption. The ICMJE defines a clinical trial as “any research project that prospectively assigns people or a group of people to an intervention, with or without concurrent comparison or control groups, to study the cause-and-effect relationship between a health-related intervention and a health outcome.”

Data sharing plans: When studies are registered in a database like clinicaltrials.gov, a data sharing plan will need to be included. Clinicaltrials.gov allows posting of such information. This requirement would need to be completed prior to the first participant being enrolled, a time when you may not necessarily know in which journal you will publish your work.

Data sharing: When a manuscript is accepted for publication for a clinical trial, the raw de-identified individual participant data will need to be shared within six months. This includes any data that was used to generate tables, figures, and appendices or supplementary material. In addition, when the manuscript is submitted for review, authors will be required to explain how the de-identified participant data will be shared.

The ICMJE also proposes certain safeguards to protect investigators: “First, ICMJE editors will not consider the deposition of data in a registry to constitute prior publication. Second, authors of secondary analyses using these shared data must attest that their use was in accordance with the terms (if any) agreed to upon their receipt. Third, they must reference the source of the data using a unique identifier of a clinical trial’s data set to provide appropriate credit to those who generated it and allow searching for the studies it has supported. Fourth, authors of secondary analyses must explain completely how theirs differ from previous analyses.”

Journals that belong to ICMJE include the Annals of Internal Medicine, the Lancet, the New England Journal of Medicine, JAMA and PLOS Medicine, just to name a few. Many other journals follow ICMJE publishing requirements.

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