ABPI/BIA issue guidelines to improve conduct of early-stage clinical trials

In the wake of the clinical trial disaster earlier this year with TGN1412 at the UK's Northwick Park hospital, when six healthy volunteers suffered extremely severe reactions to the drug, the Association of the British Pharmaceutical Industry and the BioIndustry Association have made recommendations to enhance and clarify the existing guidelines governing testing of new medicines.

Proposed by the joint taskforce set up by the ABPI and BIA (Marketletters passim), these are particularly applicable to experimental drugs whose effect on humans is unpredictable, as was the case with German firm TeGenero's potential rheumatoid arthritis candidate, TGN1412, and come out before the UK government-commissioned report on the trials by Gordon Duff, professor of molecular medicine at Sheffield University.

According to a joint ABPI/BIA statement, "the taskforce has highlighted aspects of those guidelines that are particularly important for the very small proportion of clinical trials in which novel agents stimulating the immune system are given to humans for the first time. Within this arena, recommendations cover the whole range of the Phase I development sequence, from comments and advice on the compound's mechanism of action and biological activity through to the education and training of those involved in safety assessment."