The Association of the British Pharmaceutical Industry has published a revised set of guidelines for the conduct of Phase I clinical trials, which incorporates the key recommendations made by Sir Gordon Duff in his report on the TGN1412 clinical trial fiasco at Northwick Park last year.
The ABPI says its Guidelines for Phase I Clinical Trials are a long-standing reference points for those conducting research, offering detailed information on the responsibilities of the principal investigator, nurses and support staff, pharmacy, manufacture and site facilities.
But following the failed Phase I clinical trial at Northwick Park last year, in which six volunteers became seriously ill with organ failure shortly after being administered the antibody TGN1412, the ABPI undertook a wide consultation on good practice with industry, clinical experts and stakeholders, including advice on dosing calculations, to ensure the safety of trial volunteers.
“Safety of volunteers for Phase 1 clinical trials is paramount, and this is
at the heart of the revised guidelines,” said Dr Richard Barker, ABPI
director-general. “While the events surrounding the TGN1412 trial were unprecedented, we nevertheless have to do everything to ensure that they never occur again. As a result, conclusions and recommendations made in Sir Gordon Duff’s report have been incorporated into the revised guidance,” he explained.
A more detailed report on the changes to the guidelines will be published next week in both PharmaTimes UK News and PharmaTimes Clinical News.