UK government tightens rules on drug trial results

BMJ 2008; 336 doi: (Published 13 March 2008) Cite this as: BMJ 2008;336:576
  1. Rebecca Coombes
  1. 1London

The UK government is to increase drug companies’ responsibility to pass on information about clinical trials.

The move comes after the regulators announced last week that it could not prosecute GlaxoSmithKline (GSK) for non-disclosure of trial data that showed it was unsafe for children younger than 18 to take the antidepressant paroxetine (Seroxat).

The Medicines and Healthcare Products Regulatory Agency (MHRA) issued the final report of its four year investigation into GlaxoSmithKline, during which investigators sifted through one million pages of evidence. It concluded that the drug company hadn’t broken the law but criticised it for not reporting the information earlier. GlaxoSmithKline denied it had …

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