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October 3, 1959

The Clinical Evaluation of New Drugs

JAMA. 1959;171(5):624. doi:10.1001/jama.1959.03010230122028

This collaborative work by highly respected authorities in the field presents a survey of the problems and pitfalls involved in the evaluation of a new drug, from its initial study in animals, through clinical trials, until its introduction into general medical practice. The emphasis is on investigation in human patients. The wide range of topics covered includes not only such technical subjects as experimental design and statistical analysis but also the delicate question of the ethics of experimentation on human beings. It is an excellent guidebook "for the many who participate in the search for and evaluation of better and safer drugs to treat human disease." It should prove helpful not only to the investigator but also to the practicing physician whose primary interest is in appraising published reports of drug evaluation and in distinguishing the well-planned and competently executed experiment, on which valid conclusions can be based, from the

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