Use of statistics in the analysis of side effect data from clinical trials of psychoactive agents.

1. Evaluation of the side effects of psychoactive drugs presents a special statistical situation because many of the symptoms of psychiatric disorders are also potential side effects. 2. Reported incidences of adverse events can be viewed as being a combination of psychoactive drug effects, disease state effects and other concomitant effects. 3. An intriguing statistical problem is to develop methodology to separate these effects. 4. This paper discussed four methodologies for estimating incidence of side effects assessed with a symptom and side effect check list.