CCRA statement in response to the serious adverse events that occurred in a French Phase one trial

The Clinical & Contract Research Association (CCRA) extends deepest sympathies to the volunteers who have been injured while taking part in a French Phase one trial. Our thoughts are with them and their families.

New medicines are tested in humans only after extensive and thorough laboratory and animal testing. Phase one trials are the first time a new medicine is tested in humans. First in human studies are usually, as in the case of this French trial, carried out in a small group of healthy volunteers. These studies are used to test the safety of the new medicine and to identify side effects. The information gained from these studies is needed to develop safe and effective medicines.

While Phase one studies may sound dangerous, rigorous procedures are in place to protect volunteers and to ensure that the risk of harm is minimal. Every year CCRA members and the Pharma industry carry out many hundreds of Phase one studies in Europe without incident. No company or doctor would involve volunteers in a study if they anticipated or knew there was a risk of causing major harm. As an added safeguard for volunteers all Phase one trials carried out in the European Union are scrutinised rigorously and independently by a research ethics committee and by a national drug regulatory agency. Nevertheless it is not possible to predict, and therefore avoid, all risks, but major adverse events occur very rarely.

Professor Atholl Johnston FFPM, FRCPath
President of CCRA
Saturday, 16 January 2016

CCRA is a not-for-profit organisation originally founded to represent independent clinical research contractors and allied industries.