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NICE guidance in schizophrenia: how generalisable are drug trials?

University of Oxford, Warneford Hospital, Oxford OX3 7JX, e-mail: tom.burns{at}psych.ox.ac.uk

THE UK SCHIZOPHRENIA CARE AND ASSESSMENT PROGRAMME (SCAP)

Declaration of interest

The UK-SCAP study was funded by Eli Lilly and three members of the UK-SCAP group are employees of Eli Lilly.

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.

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