Practical clinical trials for schizophrenia.

In order to meet the requirements of regulatory agencies efficiently, efficacy trials establish the short-term safety of a drug and its ability to lessen target symptoms under ideal circumstances. These trials provide little information about how interventions will work in the real world, where clinicians exercise considerable judgment in making recommendations, patients make choices about the treatments they are offered, and where costs, convenience, and comfort have significant influence. A result is the so-called efficacy-effectiveness gap in which treatments are found less beneficial in typical circumstances rather than in the ideal circumstances of efficacy trials (Institute of Medicine, 1985). In addition, efficacy trials do not answer many important questions faced by patients, clinicians, and policy makers. Because efficacy trials usually compare new drugs to placebo or a single active drug, they often do not provide direct information regarding a treatment's efficacy compared to the most commonly used treatments. Further, they are not concerned with many important out-