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New Clinical Trial Guidelines Reflect Northwick Park Lessons, UK

Medical News Today
18 Aug 2007
http://www.medicalnewstoday.com/articles/79983.php

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.