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July 27, 1963

Liability in Use of Investigational Drugs

Author Affiliations

Washington, DC

Professor of Medicine and Director, Renal and Electrolyte Division, Georgetown University.

JAMA. 1963;185(4):259-263. doi:10.1001/jama.1963.03060040043019

RECENT DEVELOPMENTS, including the growth of clinical research centers, the new regulations of the Food and Drug Administration (FDA), and the publicity surrounding the reported adverse reactions to thalidomide have prompted this examination of the moral and legal entanglements facing the clinical investigator.

Purpose of Clinical Investigator  The primary purpose of clinical investigation is to produce scientifically reliable data which will serve to answer specific questions or, simply, to satisfy the investigator's scientific curiosity. Any such investigation, therefore, must be done within the framework of a rational experimental design. Moreover, since the purpose of a drug investigation is to acquire and interpret reliable data which may lead to the proper application of new therapeutic agents, it must include basic, clinical, and therapeutic studies—all of these are necessary if medicine is to advance in knowledge and wisdom. Finally, it is not necessarily the purpose of the clinical investigator to avoid controversy,

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