Yale University
Department of Statistics

Monday, September 18, 1995
Seminar to be held in Room 309, LEPH, 60 College Street

L. J. Wei
Department of Biostatistics,
Harvard University

Play the winner in Clinical Trials

A play the winner rule for Phase II/III trials is a data dependent treatment allocation rule. Instead of using 50-50 assignments, this design repeatedly uses information collected during the trial to modify the rule of allocating incoming study patients. The goal of using such a design is to place more study patients on the better arm, but still gather reliable information about the treatment effects for the benefit of future patients. We will discuss various types of play the winner rules with real life examples. We will discuss how to analyze the data with such designs from a frequentist point of view. Potential usage of the play winner rule in AIDS and cancer clinical studies will also be discussed.