Clinical Trial Methodology: Issues for the Psychopharmacologic Treatment of the Anxiety Disorders

A number of years ago a Food and Drug Administration task force was established to develop guidelines for the conduct of psychoactive drug trials with geriatric patients. After three days of sometimes heated discussion one of the panel members volunteered to write a first draft of these guidelines for the next meeting. Other panel members were very impressed by this individual’s willingness to take on this formidable task. In due time a draft of the guidelines arrived and read very well until one came to a sentence that contained the word “children.” It then became apparent that these were the guidelines that had been developed for pediatric drug trials and what our volunteer had done was to substitute the word elderly for the word children in the pediatric guidelines. This true story is a dramatic example of the fact that, in general, methodological issues in the conduct of drug trials transcend age, sex, or psychiatric diagnosis. Small sample size is a problem whether you are conducting a drug trial with children, the elderly, men, schizophrenics or patients with panic disorders.