title: How Adaptive Trial Designs can Increase Efficiency in Psychiatric Drug Development: A Case Study.
abstract: This paper uses a recently completed study to illustrate how adaptive trial designs can increase efficiency of psychiatric drug development. The design employed allowed a continuous reassessment of the estimated dose-response such that patients were randomized in a double-blind fashion to one of seven doses of the investigational drug, placebo, or active comparator. The study design also permitted early detection of futility allowing for early study termination. By using the adaptive trial design approach, only 202 patients were needed to make the determination of futility. In contrast, a conventional design would have required enrollment of 450 patients and considerably more time and expense to reach the same conclusion. Adaptive trial designs are important at this time when many pharmaceutical companies are abandoning the development of psychiatric medications because of the inefficiency of conventional approaches.
authors.affiliation: Dr. Shen is Senior Director, Pfizer Inc., Collegeville, Pennsylvania;
authors.forename: Joan
authors.initials: J
authors.lastname: Shen
authors.forename: Sheldon
authors.initials: S
authors.lastname: Preskorn
authors.forename: Vladimir
authors.initials: V
authors.lastname: Dragalin
authors.forename: Mary
authors.initials: M
authors.lastname: Slomkowski
authors.forename: S Krishna
authors.initials: SK
authors.lastname: Padmanabhan
authors.forename: Parvin
authors.initials: P
authors.lastname: Fardipour
authors.forename: Amarnath
authors.initials: A
authors.lastname: Sharma
authors.forename: Michael
authors.initials: M
authors.lastname: Krams