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Drop-the-losers design: Binomial case

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  • Sill, Michael W.
  • Sampson, Allan R.

Abstract

Drop-the-losers designs were introduced for normal distributions as a method of combining phase II and III clinical trials together under a single protocol with the purpose of more rapidly evaluating drugs by eliminating as much as possible the delays that typically occur between the two phases of clinical development. In the design, the sponsor would administer k treatments along with a control in the first stage. During a brief interim period, efficacy data would be used to select the best treatment (with a rule to deal with ties) for further evaluation against the control in a second stage. At the end of the study, data from both stages would be used to draw inferences about the selected treatment relative to the control with adjustments made for selection in between the two stages. Because the inferences are model based, exact confidence intervals can be determined for the parameter of interest. In the present case, the parameter of concern is the probability of a beneficial response that is dichotomous in nature.

Suggested Citation

  • Sill, Michael W. & Sampson, Allan R., 2009. "Drop-the-losers design: Binomial case," Computational Statistics & Data Analysis, Elsevier, vol. 53(3), pages 586-595, January.
    • Handle: RePEc:eee:csdana:v:53:y:2009:i:3:p:586-595
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    References listed on IDEAS

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    1. Cohen, Arthur & Sackrowitz, Harold B., 1989. "Two stage conditionally unbiased estimators of the selected mean," Statistics & Probability Letters, Elsevier, vol. 8(3), pages 273-278, August.
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    Cited by:

    1. Riyadh Rustam Al-Mosawi & Shahjahan Khan, 2018. "Estimating moments of a selected Pareto population under asymmetric scale invariant loss function," Statistical Papers, Springer, vol. 59(1), pages 183-198, March.

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