Quality of reports of clinical trials submitted by the drug industry to the Finnish and Swedish control authorities

Abstract

The purpose of the present study was to investigate the quality of trials used in support of applications for licensing drugs. All applications for psychotropic drugs received by the Finnish and Swedish drug control authorities in the years 1965, 1970, 1974, and 1975 were studied. In addition, a random sample of applications for "other drugs" was selected in Finland. All reports of clinical trials on the therapeutic efficacy of the drugs were included. Many trials were uncontrolled, and in controlled trials major drawbacks in the quality of the trial design and in the accuracy of reporting were often found. The number of patients in each controlled trial was small, and the majority of trials concerned selected groups of patients. Measures of effectiveness were often such that it was impossible to establish the overall benefit of the drug. Treatment times were short. Adverse effects were handled separately and were not adequately combined with efficacy. When a decision about licensure of a drug is made, it is not enough to know that the drug affects body systems, but its therapeutic value should also be established. The trials attached to the applications for licensing did not usually do that.