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LONDON - British experts have recommended tighter rules governing clinical trials of higher-risk drugs, such as monoclonal antibodies, following a drug test that went badly wrong earlier this year.
Six healthy volunteers were left seriously ill in March after being given the experimental rheumatoid arthritis and leukemia drug TGN 1412. The disaster caused widespread public concern about the safety of early-stage, or Phase I, tests.An interim report by government-appointed experts said on Tuesday that the first dose of such drugs should be given to one person only.In the case of TGN 1412, all six men were given the medicine at the same time and suffered multiple organ failure.The experts added that drugs affecting the immune system, such as TGN 1412, might be more suitable for testing first on patients suffering disease rather than on healthy individuals.
The interim report into the TGN 1412 trial by Professor Gordon Duff, an authority in molecular medicine at Sheffield University, echoed recommendations published by a joint industry taskforce on Monday.
Representatives of drug manufacturers were not included on Duff's committee.
Duff's final report is expected by the end of November and the government is likely to incorporate its suggestions into new guidelines for regulating the conduct of clinical trials.
"Clinical trials in general have an excellent safety record, but in the light of the TGN 1412 incident there is a need to look at the future safety of clinical trials involving novel and potentially higher risk drugs," Duff said.
Privately owned German biotech firm TeGenero, which made TGN 1412, filed for insolvency earlier this month as the publicity surrounding the disastrous Phase I study made it impossible for it to attract investment to keep operating.
The trial of TGN 1412 was conducted on TeGenero's behalf by contract research firm Parexel at Northwick Park Hospital in northwest London.
