Missing clinical trial data: setting the record straightBMJ 2010; 341 doi: https://doi.org/10.1136/bmj.c5641 (Published 12 October 2010) Cite this as: BMJ 2010;341:c5641
- Fiona Godlee, editor1,
- Elizabeth Loder, associate editor1
- 1BMJ, London WC1H 9JR
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with synthesising evidence on the antidepressant reboxetine encountered serious obstacles when they tried to get unpublished clinical trial information from the drug company that held the data, an experience from which they draw several lessons (doi:10.1136/bmj.c4942).2
Once they were able to integrate the astounding 74% of patient data that had previously been unpublished, their conclusion was damning: reboxetine is “overall an ineffective and potentially harmful antidepressant” (doi:10.1136/bmj.c4737).3 This conclusion starkly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 …
Log in using your username and password
Log in through your institution
Subscribe from £173 *
Subscribe and get access to all BMJ articles, and much more.
* For online subscription
Access this article for 1 day for:
£38 / $45 / €42 (excludes VAT)
You can download a PDF version for your personal record.