Failure to inform public is undermining confidence in clinical trials

Failure to fully inform the public about the involvement of participants in clinical trials is undermining confidence in the process–and in turn leading to a reduction in the number of studies involving humans.

That was the message from Dr Philip Noguchi, director of the Division of Cellular and Gene Therapies at the Food and Drug Administration, speaking at a recent meeting of the Regulatory Affairs Professional Society in Washington, DC. The credibility of clinical research in this country has been severely damaged,” he said.

The immediate trigger of the concern has been the conduct of gene therapy studies. “Of all the fields that the FDA regulates, gene therapy is the one which is in the public eye,” Dr Noguchi said. But the situation involves all clinical research.

He cited one widely publicised event, the death in 1999 …