Editorials

Liberating the data from clinical trials

BMJ 2015; 351 doi: https://doi.org/10.1136/bmj.h4601 (Published 16 September 2015) Cite this as: BMJ 2015;351:h4601
  1. David Henry, professor1,
  2. Tiffany Fitzpatrick, meta-data specialist2
  1. 1Dalla Lana School of Public Health, Institute for Health Policy Management and Evaluation, University of Toronto, and Senior Scientist, Institute for Clinical Evaluative Sciences, Toronto, ON, Canada
  2. 2Ontario Strategy for Patient-Oriented Research (SPOR) Support Unit, Toronto, ON, Canada
  1. Correspondence to: D Henry david.henry{at}ices.on.ca

Liberated trial data have enduring potential to benefit patients, prevent harm, and correct misleading research

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 …

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