ABPI new Phase I guidelines expected

A year after the disastrous TGN1412 Phase I clinical trial at Northwick Park, UK, which caused severe adverse reactions in six people (Marketletters passim), a spokesman for the Association of the British Pharmaceutical Industry has confirmed that the trade association is currently revising its guidelines for members carrying out such trials.

Richard Tiner, the ABPI's medical director, told the Financial Times that the insurance level of L2.0 million ($3.9 million) by the German drugmaker TeGenero was lower than the level recommended by the trade body. An insurance level of about L5.0 million would have been more appropriate, an ABPI representative told the Marketletter.

Despite having published proposals for new guidelines last year, these have not yet been ratified by the ABPI. Richard Ley, a spokesman for the ABPI told the Marketletter that the internal guidelines had been in the process of being revised at the time of the TGN1412 incident. This review was suspended, in order that any lessons could be taken into account from the UK government-commissioned report by Gordon Duff into the trial's failure. The ABPI and the BioIndustry Association produced a set of proposals for improving clinical trial procedures and submitted them for consideration by Prof Duff's inquiry (Marketletter July 31, 2006), which were broadly adopted. Mr Ley added that the revised guidelines should be in place "within weeks rather than months."