The Pharmaceutical Journal
Vol 278 No 7448 p448
21 April 2007

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European guidelines on first-in-man clinical trials proposed

Draft guidelines on first-in-man clinical trials have been published by the European Medicines Agency (EMEA).

The guidelines have been developed in response to the severe adverse events suffered by volunteers in the TGN1412 trial at Northwick Park in March 2006 (PJ, 18 March 2006, p307).

The EMEA aims to provide a common approach across EU member states to the design and conduct of first-in-man clinical trials of high-risk products. The guidelines broadly mirror the suggestions made by the Government’s expert scientific group on pre-clinical and phase I trials (PJ, 16 December 2006, p727), including recommending sequential dosing and adequate intervals between doses.

Consultation on the guidelines (PDF 90K) will close on 23 May 2007.