A METHOD FOR THE ASSESSMENT OF REPORTS OF DRUG TRIALS

Abstract

A stepwise method for the assessment of reports of drug trials was used to determine the validity of drug reports published in The Canadian Medical Association Journal during the five-year period, January 1, 1956, to December 31, 1960. The method is simple and consists of applying four criteria: (1) the presence of adequate controls; (2) randomization of treatments; (3) objective assessment of drug effects; and (4) statistical analysis of results. If these criteria were absent, the assessment was stopped, and the report was felt to be invalid. A total of 203 articles were reviewed and 11 were found to fulfil these criteria. During the same period of time there were 93 additional case reports of drug effects, 39 of which described the effectiveness of a drug without there being adequate controls. The remainder of the case reports described drug toxicities.