Psychotropic drug registration in the scandinavian countries: The role of clinical trials

Abstract

Abstract In this study we report the part clinical trials have played in the registration (licensing) of psychotropic drugs in Finland, Norway and Sweden. We studied the number and quality of clinical trials in the applications submitted by the drug industry to control authorities in the years 1965, 1970 and 1974/75, and the consideration of these applications by the control authorities. Applications for new single drugs contained many clinical trials, but most of them were uncontrolled, otherwise deficient or concerned only some of the indications applied for. Applications for new combination preparations as well as for synonym drugs rarely included controlled trials. The amount of clinical evidence increased with time, but this was largely because the numbers of combination and synonym drugs decreased. Comparisons with the applications for registration for other drugs showed that the applications for psychotropic drugs were not atypically poor. Different trials were often used in the applications for the same drug in Finland and Sweden, and not all trials notified to be carried out in Finland were included in the Finnish applications. The process of deciding whether or not a drug should be registered varied in the three countries as well as the decisions. Registration seemed to be easiest in Finland and strictest in Norway. In Finland and Sweden we related the quality of clinical trials to the decisions about registration. New drugs were sometimes registered for indications for which there were no good controlled trials. Thus, efficacy could not have been proved by the documentation included in the application. The following recommendations are made: re-evaluation of the efficacy of registered drugs should be carried out, and new registration criteria, an active registration policy, and different resource allocation could be considered.