ditors from leading medical journals proposed expansive new data-sharing requirements Wednesday for authors writing about clinical experiments. The proposal, announced in an editorial jointly published by 14 journals in several nations, said researchers conducting human tests had “an ethical obligation” to trial subjects to report their data. It proposes that any authors wishing to publish in those journals must make detailed data available to other researchers on request.
Dr. Darren B. Taichman, lead author of the editorial and deputy editor of the Annals of Internal Medicine, said the proposal assumes data from each study would be made available according to a sharing plan written by the trial researchers. In some cases, data might be publicly available, in others it could be restricted to “qualified” requestors, such as scientists working on similar studies.
If adopted by the International Committee of Medical Journal Editors, the requirement would take effect in April 2017. The group — including the editors of the Journal of the American Medical Association, the New England Journal of Medicine, The Lancet, PLOS Medicine, the Annals of Internal Medicine, and the Chinese Medical Journal — is now soliciting public comment.
article continues after advertisement
Hundreds of journals ostensibly require registration of such trials as a condition of publication, but the requirement has been unevenly enforced at best. The latest proposal contains no specific enforcement requirements, but suggests that if authors violate the transparency rules, editors could voice concern, notify trial sponsors, “or in certain cases … retract the publication.”
A STAT investigation recently detailed the widespread failure of clinical research organizations to share experimental results as required by law. Failures to report results for new drugs and devices keep trial volunteers in the dark about the possible benefits of the studies, and can prevent other researchers from building on the work.
Experts cited the problem as a possible contributing factor in the recent testing disaster in France, in which one trial volunteer died and others suffered apparent brain damage.
The journal editors’ proposal would require a data sharing plan to be filed along with registration on ClinicalTrials.gov, the data repository operated by the US National Institutes of Health, or other registries if they develop the capacity to incorporate data plans. Within six months after publication, authors would be required to share underlying individual-patient data details, after personal identifiers have been redacted. Advocates for transparency in clinical trials have long called for such detailed data sharing.
Journal editors would attempt to track whether researchers were living up to their data-sharing commitments, Taichman said, but in many cases would not have ways to check on compliance.
“Science, ultimately, is an honor system. People who want to cheat will do so, and hopefully they will get caught,” he said.