Healthy Skepticism Library item: 5758

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Publication type: Journal Article

Kmietowicz Z.
Rules for drug trials should be tightened, say experts
http://bmj.bmjjournals.com/cgi/content/short/333/7562/276-a?etoc%3e 2006 Aug 01; 333:(7562):276
http://bmj.bmjjournals.com/cgi/content/short/333/7562/276-a?etoc%3e

Abstract:

Experts have made a raft of recommendations about how early clinical studies of new drugs should be designed, to improve their safety for the people taking part.

An interim report from an expert scientific group chaired by Gordon Duff, professor of molecular medicine at Sheffield University and chairman of the government’s Commission on Human Medicines, says that new high risk agents in phase I studies-the first time drugs are tested in humans-should be given to one person at a time, with an appropriate observation time between doses. The report follows events at Northwick Park Hospital, in London, where six volunteers were left seriously ill in a trial of the drug TGN1412 after all being given the drug at the same time (BMJ 2006;332: 682)

In the trial of TGN1412 the men started to develop severe reactions within a few hours of being given the drug .