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Germany may change drug testing rules after debacle in England

Heidelberg Annette Tuffs

After the catastrophic events at Northwick Park Hospital, in London, last month, when six volunteers became severely ill in a phase I trial, German experts are discussing stricter regulations for trials. The reason for the severe adverse events is unclear, and one of the six male volunteers was still being kept heavily sedated as the BMJ went to press this week (BMJ 2006;332:683, 25 Mar).

Originally, Parexel, the contract research organisation running the study, had planned to carry it out in Berlin but moved it to London because approval from the Medicines and Healthcare Products Regulatory Agency, the UK regulatory authority, came through earlier than approval from the Paul-Ehrlich-Institut, the German federal agency for the use of biological medical products.

Germany is involved, however, because the trial was commissioned by a German company, the small biotech firm TeGenero in Würzburg, northern Bavaria, which was started several . . . [Full text of this article]

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Relevant Article

Severe adverse reactions prompt call for trial design changes

Susan Mayor
BMJ 2006 332: 683. [Extract] [Full Text] [PDF]