The Pharmaceutical Journal
Vol 277 No 7411 p124
29 July 2006

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Regulators and manufacturers should work more closely together

Regulators and drug developers need to communicate more closely with one another, and UK schools of medical sciences, including pharmacy, should consider organising secondments to commercial clinical trial organisations, the expert scientific group established to examine clinical trials has concluded.

Drug developers and regulators need to talk to each other before an application is filed, the group recommends, and they should aid the collection of information on unpublished preclinical and phase I studies, and consider the feasibility of making these data available on an open access basis.
It also argues that, because so many phase I trials are being carried out by commercial clinical research organisations, UK universities and the NHS have fewer opportunities to develop and teach the skills needed by the next generation of phase I specialists. “We recommend that the availability of ‘hands-on’ experience in the planning and conduct of clinical trials should be widened, for example, by secondment periods to commercial organisations within postgraduate training programmes, or the development of specialist centres within the NHS and universities,” the group says.

The group was set up by the Secretary of State for Health following the serious adverse reactions that occurred in the phase I clinical trial of TGN1412 in March (PJ, 25 March, p342, and 8 April, p408). It makes 22 recommendations in its interim report, issued this week. It argues that in phase I trials of novel biological molecules:

· Calculations of initial dose should consider all relevant factors, possibly using new statistical methods or computer modelling.

· Decisions on whether to use healthy volunteers or patients should be made on a case-by-case basis for each drug.

· Drugs should be administered to each subject in sequence with an adequate time delay between each dose to allow observation of any adverse reaction.

· Regulation of first-in-man trials should be subject to frequent review.

The group is consulting on the recommendations of the report until 14 September and will issue a final report by the end of November. The full report is available.