Psychopharmacology Research Ward. Ten Years' Experience

Abstract

The differences between the results of controlled clinical research and the experiences of the practitioners can be attributed to a certain extent to the artificiality of the setting in which controlled studies are performed. The system developed in the wards of the Department of Psychopharmacology of the Institute of Psychiatry in Prague is an attempt to overcome some of these difficulties. Certain similarities exist between this system called continuous controlled trial and 'silent' trial proposed by Ross et al. The main characteristics of the system are: (1) all patients admitted to the ward are assigned to the trial without exception; (2) the trial goes on continuously without interruption for more than 10 years; (3) except that the patients do not know the quality of drugs administered they do not realize any difference between this research setting and the usual routine treatment. The advantages of this system are: reduction of artificiality; the possibility to perform early clinical trials in controlled conditions and to shorten the usual three-phase testing of a new drug; the possibility to perform long-term, longitudinal studies with individual patients admitted several times in double-blind conditions.