Issues in the Design and Conductance of Clinical Trials

Clinical trials are conducted to determine the therapeutic efficacy, effectiveness, safety, and tolerability of interventions for clinical disorders. The best clinical trials are designed to do this efficiently with minimal potential for bias. This chapter focuses on the clinical trials of pharmacological interventions for psychiatric disorders, in particular, how translational models can improve the quality of these trials. The implementation of clinical trials is fraught with hazard. Present methods are incapable of assuring that the best patients are included in trials and that the true effects of assigned treatments are consistently captured. Inference making should be cautious and restrained. Only after multiple trials are completed by several groups of investigators using differing methodologies produce concordant results whether it should be believed that the findings are well supported and are to be used in the practice. As the back and forth process of developing translational models of pathophysiology and pharmacological actions in laboratory and clinical settings proceeds, clinical trials will become more objective and this will hasten the development of clinically useful medicines. Re-engaging dedicated clinical investigators will enhance the quality of this process.