The Pharmaceutical Journal
Vol 277 No 7431 p727
16 December 2006

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Open-access database needed for unpublished trial data

Unpublished clinical trial information should be made available in an open-access database, the expert group established in the wake of the TGN1412 trial disaster recommends in its final report.

The group also suggests that initial doses of experimental medicines should be given to patients one at a time with an adequate interval between each and that the dose should be calculated on a broader basis than “no observable effect level”.

Secretary of State for Health Patricia Hewitt established the expert scientific group to look at the transition from pre-clinical to phase I trials and the design of these trials in the aftermath of the TGN1412 clinical trial at Northwick Park, London, in March, which led to six men being admitted to intensive care (PJ, 18 March, p307 and 8 April, p408). The group published an interim report in July (PJ, 29 July, p124).


News feature p730