History of FDA Regulation of Clinical Research

Abstract

Since 1962, when the Food and Drug Administration was given broad power to regulate investigations of new drugs, several major regulatory themes have emerged. First, the FDA has sought to protect the rights of human subjects by demanding adequate preclinical safety studies and requiring that investigators obtain subjects' informed consent and give proper consideration to ethical issues. Second, the FDA has sought to ensure the integrity of data produced by clinical trials through recordkeeping requirements and enforcement actions against investigators and sponsors. Finally, the FDA has to some extent involved itself in the scientific merits of proposed research, although the Agency's role in this regard has been controversial. Recent revisions in the FDA regulations governing investigational new drugs are unlikely to make fundamental changes in the Agency's programs.