Med journal editors outline data sharing plan for clinical trials

Data sharing is essential to ensuring the integrity of clinical trial results and fulfilling an ethical obligation to study participants, according to an editorial from the International Committee of Medical Journal Editors (ICMJE) published online Jan. 20 in Annals of Internal Medicine.

The ICMJE, whose membership includes the editors of JAMA and the New England Medical Journal, proposed a set of clinical data sharing requirements that must be met before trial results will be considered for publication in their member journals.

“Enabling responsible data sharing is a major endeavor that will affect the fabric of how clinical trials are planned and conducted and how their data are used,” the authors wrote. “By changing the requirements of the manuscripts we will consider for publication in our journals, editors can help foster this endeavor.”

The committee’s proposals include:

  • A requirement that authors share the deidentified individual-patient data (IPD) underlying the results presented in the article (including tables, figures, and appendices or supplementary material) no later than 6 months after publication.
  • The required inclusion of a comprehensive data-sharing plan, including information about where and how data will be stored, in the submitted manuscript.
  • Safeguards to ensure the reasonable rights of investigators and trial sponsors, including requirements for authors to properly cite data and provide appropriate credit to those who generated it.
  • If enacted, the requirements would be deferred one year to allow investigators, trial sponsors, and regulatory bodies time to plan for their implementation.

According to the ICMJE, the adoption of these proposals among its member journals is critical to maintaining the veracity of clinical trial results, a responsibility that is shared among editors and researchers alike.

“Sharing data will increase confidence and trust in the conclusions drawn from clinical trials,” the authors wrote. “It will help to fulfill our moral obligation to study participants, and we believe it will benefit patients, investigators, sponsors, and society.”

The committee is encouraging feedback to the proposed requirements and will accept comments through April 18.