Good Clinical Practices in the US: Impact of European Guidelines

Abstract

The Food and Drug Administration (FDA) must be assured that the clinical trials of new drugs are properly conducted, that the data are accurately reported, and that the risks to the subjects are minimized, regardless of whether the studies are performed in the United States or in foreign countries. The FDA's standards for conducting clinical trials are set forth in the Investigational New Drug regulations, the Protection of Human Subjects regulations, and the Institutional Review Board (IRB) regulations. The FDA has also prepared monitoring guidelines for sponsors, and numerous other guidelines for clinical investigators and institutional review boards. Regulations, guidelines, and the criteria for the acceptance of foreign drug studies are reviewed. An overview of foreign clinical inspections is presented and the perceived impact of the European Community (EC) Good Clinical Practices requirements is discussed.