Regulations on medical research need to be reinterpreted not rewritten

BMJ 2010; 340 doi: (Published 24 May 2010) Cite this as: BMJ 2010;340:c2732
  1. Zosia Kmietowicz
  1. 1London

    Removing the barriers that are currently “stifling” medical research in the United Kingdom will not require new rules on clinical trials to be written but for existing ones to be reinterpreted, the body charged with reviewing the regulation and governance of medical research has said.

    The European Clinical Trial Directive, implemented in 2004, was intended to harmonise research across the continent and improve competitiveness in Europe. But it has been interpreted differently in different countries and in the UK has become “unbelievably complicated and burdensome, and, in many cases, it is not appropriate,” said Michael Rawlins, chair of the working party of the Academy of Medical Sciences, which is conducting the review. He was speaking at a press briefing on 20 May, two days after the first meeting of the working party.

    The review was commissioned in March by the then secretary …

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