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Thursday, August 16th, 2007
Key recommendations from Sir Gordon Duff’s report into the TGN1412 clinical trial at
Northwick Park last year have been incorporated into revised guidelines about the conduct
of Phase 1 clinical trials, published by the Association of the British Pharmaceutical
Industry (ABPI).
The ABPI Guidelines for Phase 1 Clinical Trials have long been used as a reference by those
running such trials. They cover the responsibilities of the principal investigator (doctor),
nurses and support staff, pharmacy, manufacture and site facilities.
The updated guidelines are the result of wide consultation on good practice with industry,
clinical experts and stakeholders, including advice on dosing calculations. They update
previous ABPI guidelines for Phase 1 trials, which relate to the testing of potential
medicines in healthy volunteers before they can go on to further testing in patients.
“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.”
The guidelines can be found online.
For further information, please contact:
Crispin Slee 020 7747 1410 (office)
Roz Britton-Elliott 020 7747 1441 (office)
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