To minimise risks involved in testing new drugs on people, the Royal Statistical Society has called for changes to the way clinical trials are conducted.
'Drug regulatory bodies must take a leading role in analysing, sharing and communicating data on risk to all parties,' said Stephen Senn, chair of the working group that was set up following last year's TGN1412 drug trial incident (C&I 2006, 9, 21). The working party found problems in the linkage of the databases held by the Medicines and Healthcare products Regulatory Agency (MHRA) on first-in-man trials and associated serious adverse events. Senn …
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