Editors of some of the most prominent medical journals – including the New England Journal of Medicine, the Journal of the American Medical Assn., the Annals of Interal Medicine and the British Medical Journal – are proposing to require researchers to share the data behind their published studies.
“[T]here is an ethical obligation to responsibly share data generated by interventional clinical trials because participants have put themselves at risk,” the International Committee of Medical Journal Editors wrote in an editorial published today in the Annals of Internal Medicine.
“As a condition of consideration for publication of a clinical trial report in our member journals, the ICMJE proposes to require authors to share with others the de-identified individual-patient data underlying the results presented in the article (including tables, figures, and appendices or supplementary material) no later than 6 months after publication,” the editors wrote. “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 proposal would go into effect a year after the ICMJE enacts the requirement, which won’t happen until it’s had a chance to review stakeholders’ comments, the society said. The plan would require study authors to include their data-sharing plans as a component of clinical trial registration; ClinicalTrials.gov has already put a mechanism in place to facilitate this, the society said.
“Sharing data will increase confidence and trust in the conclusions drawn from clinical trials. It will enable the independent confirmation of results, an essential tenet of the scientific process. It will foster the development and testing of new hypotheses. Done well, sharing clinical trial data should also make progress more efficient by making the most of what may be learned from each trial and by avoiding unwarranted repetition. It will help to fulfill our moral obligation to study participants, and we believe it will benefit patients, investigators, sponsors, and society,” the editors wrote.
Two years ago, Johnson & Johnson (NYSE:JNJ) pledged to open up the raw data from its clinical trials, handing over raw, anonymized data from its trials of medical devices, pharmaceuticals and consumer products to the Yale School of Medicine’s Open Data Access Project.