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
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