Adaptive two-treatment two-period crossover design for binary treatment responses incorporating carry-over effects |
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Authors: | Uttam Bandyopadhyay Atanu Biswas Shirsendu Mukherjee |
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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 |
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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. |
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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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