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New ICMJE data sharing requirements come into effect imminently

It has been a year since the International Committee of Medical Journal Editors (ICMJE) announced their new requirements around data sharing, and the first threshold date is rapidly approaching. As a reminder, these requirements state that, as of 1 July 2018, manuscripts reporting the results of clinical trials in ICMJE member journals (and the large number of non-member publications that also adhere to the committee’s recommendations and standards) must contain a data sharing statement. In addition, for clinical trials that begin enrolling participants on or after 1 January 2019, a data sharing plan must be included in the trial’s registration. These requirements are likely to impact authors and publications professionals, who will need to incorporate these considerations into the planning of any clinical trial publications, and also sponsors who will need to ensure that their own data sharing policies are up-to-date and finalised.

The ICMJE data sharing requirement was an update on a previous proposal, which suggested that deidentified patient data underlying clinical study results should be shared within 6 months of publication. This proposal was met with a mixed response from researchers and authors, and as a result ICMJE stepped back from mandating data sharing, instead requiring inclusion of a data sharing statement. This itself was met with controversy, as some saw it as a missed opportunity to progress the goal of universal data sharing. ICMJE require that, as a minimum, statements indicate whether authors intend to share deidentified patient data and provide information on what, how, when and for how long data will be made available. (For full details see the table below).

ICMJE data sharing policy_table.jpg

Many journals have already begun updating their data sharing policies ahead of the new recommendations coming into effect, and may even have their own additional requirements, such as providing pre-defined statements that authors must choose from. So, be prepared —  check journal instructions for specific guidance!

What are your thoughts? Do you think this new requirement will improve transparency? Add your comments below.

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Summary by Alice Wareham PhD from Aspire Scientific

 

With thanks to our sponsors, Aspire Scientific and NetworkPharma.


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