METHODOLOGICAL AND DESIGN ISSUES IN CLINICAL-TRIALS OF NEW NEUROLEPTICS - AN OVERVIEW

The recent development of new neuroleptics that differ from the conven tional neuroleptics in both mechanism of action and side-effects profi le has introduced problems in their clinical assessment, and highlight ed ongoing issues in the design and methodology of clinical trials. Th ese issues are broadly grouped and discussed as follows: sampling prob lems 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 n ew neuroleptics, clinical settings have to be prepared for testing the ir efficacy and safety without too much delay in well designed clinica l trials.