Adaptive Designs for Normal Responses with Prognostic Factors

Abstract

Adaptive designs are often used in clinical trials to force balance in sequential allocation of patients between two or more competitive treatments. Sometimes, from ethical considerations, the goal may be to allocate a larger number of patients to the better treatment in course of the trial. In the present paper we consider patients who are heterogeneous with respect to some prognostic factors and assume that the response from each patient is a continuous variable. We consider a normal linear model and provide an allocation design with due attention to the prognostic factors. The loss of efficiency incurred by using a balanced design is also indicated. Issues of inference based on adaptive allocation are also discussed. Finally a guideline is provided for the appropriate choice of the design parameters.