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Interim Treatment Selection in Drug Development

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Abstract

We consider hypothesis testing in a clinical trial with an interim treatment selection. Recently, unconditional and conditional procedures for selecting one treatment as the winner have been proposed when the mean responses are approximately normal. In this paper, we generalize both procedures to multi-winner cases. The distributions of the test statistics are obtained and step-down approaches are proposed. We prove that both unconditional and conditional procedures strongly control the family-wise error rate. We give a brief discussion on power comparisons.

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Correspondence to Gang Li.

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Li, G., Wang, Y. & Ouyang, S.P. Interim Treatment Selection in Drug Development. Stat Biosci 1, 268–288 (2009). https://doi.org/10.1007/s12561-009-9017-y

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  • DOI: https://doi.org/10.1007/s12561-009-9017-y

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