NEW YORK (Reuters Health)—Authors should agree to share deidentified patient data as a condition for publication of a clinical trial report, according to a proposal from the International Committee of Medical Journal Editors (ICMJE).
“Our patients generously and selflessly volunteer to participate in clinical trials on the promise that the knowledge gained will be used to help others,” Dr. Darren B. Taichman, executive deputy editor, Annals of Internal Medicine, and secretary of ICMJE, told Reuters Health by email. “Making sure that the data generated are made available to ensure the most is learned from them is part of keeping that promise.”
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.”
In a Jan. 20 online commentary in the Lancet, ICMJE proposes that authors share the data underlying the results of the article within six months after publication.
According to the proposal, authors should also include the plan for data sharing as a component of the clinical trial registration, including where the researchers will house the data and the mechanism by which they will provide others access to the data.
These requirements would go into effect for clinical trials that begin to enroll participants beginning one year after ICMJE adopts its data-sharing requirements.
“Creating a scientific environment where everyone benefits from sharing clinical trial data—trial participants, investigators, sponsors, and future patients—will take time,” Dr. Taichman said. “We hope others will share their opinions on our proposed requirements at our website.”
The deadline for providing feedback on the proposal is April 18, 2016.
