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October 1958

An Experimental and Statistical Method in the Study of New Drugs

Author Affiliations

Cambridge, Mass.; Wellesley Hills, Mass.

University Health Services Harvard University (Dr. Cass); 20 Grantland Rd. (Dr. Frederik).

AMA Arch Intern Med. 1958;102(4):571-579. doi:10.1001/archinte.1958.00260210057009

The problem of relating the effectiveness of the enormous number of new drugs now being produced by the pharmaceutical houses to existing medications is exceedingly difficult. It is, however, imperative that they be evaluated in this respect and that they be integrated correctly into the therapeutic armamentarium. The preliminary work begins with the chemist and the pharmacologist and proceeds to the physiologist, as well as to the field of animal experimentation. Throughout this period, new drugs are screened for toxic reaction and pharmacologic effect.

The obvious way to test the value of a medication is to give it to patients with the required symptoms and observe the results.1 A strict procedure of checks and controls must be inaugurated and carried out, which will permit conclusions which are free of the variabilities of the subjective impression, except in cases where a medication produces a markedly obvious change, and even in

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