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Tracking switched outcomes in clinical trials

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How did NEJM respond when we tried to correct 20 misreported trials?

February 25, 2016 - by Ben Goldacre 14 Comments

It is well established that academic journals routinely permit outcome switching in the trial reports that they publish, despite public commitments to address this problem. For six weeks from October 2015, the COMPare team analysed every RCT published in the top 5 medical journals to check if they had correctly reported their pre-specified outcomes. Where we found discrepancies between the outcomes that were pre-specified and those reported, we wrote a letter to that journal to correct the record. The responses we have received from journals have been extremely varied: from full public engagement and transparent corrections in the BMJ, to inaccurate and concerning responses in the Annals of Internal Medicine.

New England Journal of Medicine (NEJM) is the highest impact factor journal in medicine. So far we have analysed 23 of their trials. To NEJM’s credit, of 32 primary outcomes pre-specified across these papers, 31 were correctly reported. However, 16 publications added in a total of 65 additional outcomes that were not pre-specified in the protocol or trial registry, and only 2 of these were declared as novel. Furthermore, a total of 160 pre-specified secondary outcomes spread across these publications were either not reported, or were reported incorrectly. Our full results and raw data are available here. Only 3 trials were perfectly reported.

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How to cite us

Prior to publication of the first paper on COMPare, please cite this project as:

The COMPare Trials Project. Goldacre B, Drysdale H, Powell-Smith A, et al. www.COMPare-trials.org, 2016.

Or alternatively:

The COMPare Trials Project. Ben Goldacre, Henry Drysdale, Anna Powell-Smith, Aaron Dale, Ioan Milosevic, Eirion Slade, Philip Hartley, Cicely Marston, Kamal Mahtani, Carl Heneghan. www.COMPare-trials.org, 2016.

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