Liberating the data from clinical trials

Despite the importance of reproducibility in research, clinical trials are rarely subject to independent reanalysis. In a linked paper, Le Noury and colleagues (doi:10.1136/bmj.h4320) have restored and reanalysed the controversial “study 329,” which incorrectly portrayed paroxetine as an effective and acceptably safe treatment for children and adolescents with major depression.1 2 The accompanying article by Doshi (doi:10.1136/bmj.h4629) details the mis-steps of the investigators, staff from the sponsoring drug company, the lead author’s home academic institution, and the publication journal.3 Study 329 is a model example for the movement to restore invisible and abandoned trials (RIAT), which calls on investigators to publish unreported trials and republish and correct misleading reports.4

In a recent review, Ebrahim and colleagues identified just 37 published reanalyses of clinical trials.5 Only five were conducted by investigators not associated with the original report. A third of the reanalyses led to interpretations that were different from those of the original articles. In a recent blog, Ben Goldacre, co-founder of the +AllTrials initiative, which calls for all trials to be registered and published,6 7 8 highlighted the example of an influential trial of intestinal “deworming” treatment. Reanalysis uncovered important errors and changed some central conclusions of the …