As of July 1, 2018, manuscripts submitted to International Committee of Medical Journal Editors (ICMJE)-member journals must be accompanied by a data sharing statement. What is the new requirement, how did it evolve, and what does it mean for data sharing?
In January 2016, the ICMJE proposed that authors of all clinical trial manuscripts published in member journals share de-identified individual-patient data (IPD) underlying their results within 6 months of publication.1 The proposal included data in tables, figures, appendices, and supplemental materials. The ICMJE invited comments on its proposal and a firestorm ensued. Although many individuals and groups applauded the ICMJE proposal, others raised legitimate concerns. Some were concerned about inappropriate analyses of data without statistical rigor, and authors were concerned about competition and losing control and/or credit for their work. Others voiced concerns about the practical aspects of how to share the huge amounts of data generated by some studies, particularly large, phase 3, randomized trials. Still others raised persistent concerns about patients’ right to privacy, particularly in the rare disease setting, where, despite de-identification efforts, patients still might be identifiable. Continue reading
