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June 1967

The Evaluation of New Drugs: Current Food and Drug Administration Regulations and Statistical Aspects of Clinical Trials

Arch Intern Med. 1967;119(6):547-556. doi:10.1001/archinte.1967.00290240069001

In THIS paper the current Food and Drug Administration (FDA) regulations pertaining to the testing of new drugs are reviewed, and a basic statistical issue of the design of a clinical trial is discussed. The regulatory procedures that are described are applicable to any sponsor of a clinical trial—whether that sponsor is a pharmaceutical corporation, a department of pharmacology within a medical school, or an individual. The validity of any conclusion concerning the effects of a new drug—both beneficial and adverse—is dependent upon the experimental design of the trial. The statistical principle discussed here provides a ruler with which to measure the sensitivity of the design of a clinical trial.

Kefauver-Harris Amendments  Prior to the passage of the 1938 Food, Drug, and Cosmetic Act, drugs could be marketed before "clearance" by the Federal Government. The clearance procedures established by the 1938 act were limited to tests for safety. The 1962