Methodological and design issues in clinical trials of new neuroleptics: an overview

Abstract

The recent development of new neuroleptics that differ from the conventional neuroleptics in both mechanism of action and side-effects profile has introduced problems in their clinical assessment, and highlighted ongoing issues in the design and methodology of clinical trials. These issues are broadly grouped and discussed as follows: sampling problems and selection of patients; design issues; problems in measurement; ensuring compliance; recognition of extrapharmacological issues; and statistical models. For patients to benefit from the development of new neuroleptics, clinical settings have to be prepared for testing their efficacy and safety without too much delay in well designed clinical trials.