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Adaptive two-treatment two-period crossover design for binary treatment responses incorporating carry-over effects

Adaptive crossover design

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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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Authors and Affiliations

  1. Department of Statistics, University of Calcutta, 35 Ballygunge Circular Road, Kolkata, 700 019, India

    Uttam Bandyopadhyay & Shirsendu Mukherjee

  2. Applied Statistics Unit, Indian Statistical Institute, 203 B. T. Road, Kolkata, 700 108, India

    Atanu Biswas

Authors
  1. Uttam Bandyopadhyay
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  2. Atanu Biswas
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  3. Shirsendu Mukherjee
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Correspondence to Uttam Bandyopadhyay.

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Bandyopadhyay, U., Biswas, A. & Mukherjee, S. Adaptive two-treatment two-period crossover design for binary treatment responses incorporating carry-over effects. Stat Methods Appl 18, 13–33 (2009). https://doi.org/10.1007/s10260-007-0072-6

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