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FDA disagrees with BMJ study that found clinical trials were not being reported

BMJ 2012; 344 doi: http://dx.doi.org/10.1136/bmj.e3277 (Published 08 May 2012) Cite this as: BMJ 2012;344:e3277
  1. Nigel Hawkes
  1. 1London

The US Food and Drug Administration has denied charges made in a study in the BMJ that rules making it mandatory to report clinical trial results are being flouted. The study, published in January by Andrew Prayle and colleagues at the University of Nottingham,1 calculated that only 22% of the trials that should have reported their results on the ClinicalTrials.gov website had actually done so.

In response to the study Henry Waxman, the Democrat Congressman for part of Los Angeles, wrote to the FDA demanding an explanation. Jeanne Ireland, the FDA’s assistant commissioner for legislation, replied, contesting the figures.

She said that the analysis included some trials that were completed before the law took effect and had not excluded all those, such as uncontrolled trials, that are exempt from the …

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