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The author has attempted to compose a Baedecker for would-be clinician-investigators and, in a broad sense, he has been successful. The roles of the major characters in a drug trial—the research monitor, the statistician, the clinical investigators, the subjects, and the Food and Drug Administration (FDA)—are defined with authority based on experience. Proper attention is also given to the matters of experimental design and sequence in drug studies.
One wishes that the excellently clear chapter on statistical foundations had been expanded, and that the item-by-item descriptions of various FDA forms relating to new drug applications had been curtailed. The latter
Proving New Drugs.. Ann Intern Med. ;71:678. doi: 10.7326/0003-4819-71-3-678
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Published: Ann Intern Med. 1969;71(3):678.
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