Responding to the scandal that erupted in the UK following a disastrous early-stage trial that sent six volunteers to the hospital, the Association of the British Pharmaceutical Industry has published new guidelines for Phase I studies which are designed to help avoid a repeat performance.
"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."
- check out the release on the new guidelines