Traditional and alternative research designs and methods in clinical pediatric psychopharmacology

Objective: To review both traditional and alternative research designs and methods in pediatric psychopharmacology. Method: Study designs used in clinical trials in psychiatry were selected for review with the special considerations of pediatric psychopharmacological trials in mind. Where possible, a reference to a specific published trial in pediatric psychopharmacology was provided for each design. Results: It appears that pediatric psychopharmacology trials require a relatively greater flexibility in design to avoid significant study biases. Alternative research designs may be preferable to the traditional approaches, particularly when the use of the latter may raise important issues of feasibility. Conclusions: Evolution of a clinical research hypothesis to a study protocol in pediatric psychopharmacology is a manageable task if one keeps in mind essential elements such as selection of study design, population, sample size, treatment duration, and efficacy assessments.