Missing clinical trial data: setting the record straight

BMJ 2010; 341 doi: http://dx.doi.org/10.1136/bmj.c5641 (Published 12 October 2010) Cite this as: BMJ 2010;341:c5641

This article has a correction. Please see:

  1. Fiona Godlee, editor1,
  2. Elizabeth Loder, associate editor1
  1. 1BMJ, London WC1H 9JR
  1. fgodlee{at}bmj.com

Urgent action is needed to restore the integrity of the medical evidence base

Like us, you have probably grown accustomed to the steady stream of revelations about incomplete or suppressed information from clinical trials of drugs and medical devices.1 If so, this issue of the BMJ features a pair of papers that will dismay but not surprise you. Researchers for an official German drug assessment body charged with synthesising evidence on the antidepressant reboxetine encountered serious obstacles when they tried to get unpublished clinical trial information from the drug company that held the data, an experience from which they draw several lessons (doi:10.1136/bmj.c4942).2

Once they were able to integrate the astounding 74% of patient data that had previously been unpublished, their conclusion was damning: reboxetine is “overall an ineffective and potentially harmful antidepressant” (doi:10.1136/bmj.c4737).3 This conclusion starkly contradicts the findings of other recent systematic reviews and meta-analyses published by reputable journals.4 5 6 7 8 These studies presumably met prevailing standards for the conduct of meta-analyses. Yet we now know that they did not provide …

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