Cancer Institute A national cancer institute
designated cancer center

Philip W. Lavori

Publication Details

  • Adaptive Trial Designs ANNUAL REVIEW OF PHARMACOLOGY AND TOXICOLOGY, VOL 52 Lai, T. L., Lavori, P. W., Shih, M. 2012; 52: 101-110

    Abstract:

    We review adaptive designs for clinical trials, giving special attention to the control of the Type I error in late-phase confirmatory trials, when the trial planner wishes to adjust the final sample size of the study in response to an unblinded analysis of interim estimates of treatment effects. We point out that there is considerable inefficiency in using the adaptive designs that employ conditional power calculations to reestimate the sample size and that maintain the Type I error by using certain weighted test statistics. Although these adaptive designs have little advantage over familiar group-sequential designs, our review also describes recent developments in adaptive designs that are both flexible and efficient. We also discuss the use of Bayesian designs, when the context of use demands control over operating characteristics (Type I and II errors) and correction of the bias of estimated treatment effects.

    View details for DOI 10.1146/annurev-pharmtox-010611-134504

    View details for Web of Science ID 000301839600006

    View details for PubMedID 21838549

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