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.”
Download the ABPI Guidelines for Phase 1 Clinical Trials (PDF, 2.8MB)
For further information, please contact: ABPI Press Office 020 7747 1410