Hogan Lovells Publications | Pharmaceutical and Biotechnology Alert | 14 February 2019

A new year, a new disclosure: ICMJE requires registrations for clinical trials beginning in 2019 to include disclosure of data sharing plan

Clinical trials starting patient enrollment this year must include a "data sharing plan" in their trial registrations (such as on ClinicalTrials.gov), according to a policy published by the International Committee of Medical Journal Editors (ICMJE) that specifies data sharing disclosure requirements for those seeking to publish the results of their clinical trials in an ICMJE-member journal.

The policy is motivated by ICMJE's belief that "there is an ethical obligation to responsibly share data generated by interventional clinical trials because trial participants have put themselves at risk," as well as ICMJE's stated goal of "helping to create an environment in which the sharing of deidentified individual participant data becomes the norm."

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