Marginal Regression for Binary Longitudinal Data in Adaptive Clinical Trials

In an adaptive clinical trial research, it is common to use certain data-dependent design weights to assign individuals to treatments so that more study subjects are assigned to the better treatment. These design weights must also be used for consistent estimation of the treatment effects as well as the effects of the other prognostic factors. In practice, there are however situations where it may be necessary to collect binary responses repeatedly from an individual over a period of time and to obtain consistent estimates for the treatment effect as well as the effects of the other covariates in such a binary longitudinal set up. In this paper, we introduce a binary response-based longitudinal adaptive design for the allocation of individuals to a better treatment and propose a weighted generalized quasi-likelihood approach for the consistent and efficient estimation of the regression parameters including the treatment effects. Copyright 2005 Board of the Foundation of the Scandinavian Journal of Statistics..