NICE guidance in schizophrenia: How generalisable are drug trials?

Abstract

Aims and method: To test the National Institute for Clinical Excellence (NICE) assertion that characteristics of participants in the majority of clinical drug trials in schizophrenia do not reflect clinical practice. In particular they were concerned about the relative exclusion of women, older adults and patients with comorbidity. The baseline characteristics of a sample of 600 patients with schizophrenia recruited to be as representative as possible of UK community practice were compared with those from one of the largest international drug trials of an atypical antipsychotic. Results: Although comparisons could only be made on a limited range of characteristics the two samples were broadly comparable. Clinical implications: Current drug trials from pharmaceutical companies may have more relevance to clinical practice than their stated exclusion criteria may indicate.