Journal to Publish Clinical Trial Protocols

Following an independent group’s finding of misreported outcomes, the Annals of Internal Medicine now requires that authors include clinical trial protocols when submitting their results.

Written byTanya Lewis
| 2 min read

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FLICKR, LUXOMEDIAThe Annals of Internal Medicine is now requiring the authors of clinical trials to publish the original protocols along with the studies, as well as any changes to those protocols, Retraction Watch reported last week (May 13). The move follows an allegation by the Compare Trials project—which tracks switched outcomes in clinical trials—that five trials published in Annals over a six-week period misreported the outcomes originally specified.

“This change was something we planned prior to Compare and were intending to implement with an update of our online journal that is in process,” Darren Taichman, the executive deputy editor of Annals, told Retraction Watch. “However, the barrier Compare encountered in obtaining a protocol for one of the studies in their audit prompted us to implement it earlier.”

According to its website, the journal now requires that “authors of manuscripts that report clinical trial results must submit the original preenrollment protocol . . . with any amendments that were made. All such material must be appropriately dated. For accepted articles reporting clinical trials, Annals will publish the protocol as a supplement to the article.”

Members of Compare Trials examined Annals clinical trial reports and ...

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