Regulatory Authority Affecting American Drug Trials: Role of the Hospital Pharmacist

Abstract

Clinical drug trials in the United States are influenced by many regulatory and policy–recommending organizations, chief among them are institutional review boards, the National Institutes of Health, the Food and Drug Administration, the American Society of Hospital Pharmacists, the Joint Commission on the Accreditation of Healthcare Organizations, and the pharmaceutical industry.

The hospital pharmacist's role is a multifaceted one ranging from protocol authorship and primary investigator status to support of institutional research programs. The latter encompasses such activities as ordering, storing, preparing, packaging, labeling, and dispensing clinical research drugs, providing investigational drug information to other health professionals associated with a particular study, and maintaining appropriate drug use accountability records. Development and maintenance of a hospital–wide quality assurance or quality improvement program as well as the provision of clinical pharmacy services to research subjects are also among the hospital pharmacist's roles related to clinical drug trials.