Clinical trials in psychiatry: Do results apply to practice?

Objective: The purpose of this communication is to alert psychiatrists to the difficulties of translating results of group difference obtained from large, randomized clinical trials to the treatment of individual patients. Method: Reported discrepancies between a) clinical trial participants and general psychiatric patients, b) clinical trial investigators and general clinicians, and c) study, trial and usual clinic conditions were assessed. Results: The results confirm that important differences exist in all 3 areas. Conclusions: Recommendations for researchers include more complete assessments of factors that account individual difference, an appraisal of outcomes move important to patients than symptom scores, and the use of statistical methods that permit the evaluation of individual difference. Recommendations for clinicians include a careful clinical differentiation of results obtained in different phases of clinical trials and a clear appreciation of the different purposes of those trials. Clinicians should also appreciate that short-term effectiveness is not the same as long-term outcome and that aggregate scores may not apply to individual patients.