Drop-the-losers design: Binomial case

Michael W. Sill and Allan R. Sampson

Computational Statistics & Data Analysis, 2009, vol. 53, issue 3, 586-595

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.

Date: 2009
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