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Adaptive two-treatment two-period crossover design for binary treatment responses incorporating carry-over effects
Authors:Uttam Bandyopadhyay  Atanu Biswas  Shirsendu Mukherjee
Institution:(1) Department of Statistics, University of Calcutta, 35 Ballygunge Circular Road, Kolkata, 700 019, India;(2) Applied Statistics Unit, Indian Statistical Institute, 203 B. T. Road, Kolkata, 700 108, India
Abstract:Adaptive designs are sometimes used in a phase III clinical trial with the goal of allocating a larger number of patients to the better treatment. In the present paper we use some adaptive designs in a two-treatment two-period crossover trial in the presence of possible carry-over effects, where the treatment responses are binary. We use some simple designs to choose between the possible treatment combinations AA, AB, BA or BB. The goal is to use the better treatment a larger proportion of times. We calculate the allocation proportions to the possible treatment combinations and their standard deviations. We also investigate related inferential problems, for which related asymptotics are derived. The proposed procedure is compared with a possible competitor. Finally we use real data sets to illustrate the applicability of our proposed design.
Keywords:Asymptotic power  Conditional test  Ethics  Limiting proportion of allocation  Maximum likelihood estimates  Play-the-winner rule  Randomized clinical trials  Randomized play-the-winner rule  Repeated measurement designs
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