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Discussion on “Adaptive enrichment designs with a continuous biomarker” by Nigel Stallard

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  • Nancy Flournoy
  • Sergey Tarima

Abstract

We congratulate Dr. Nigel Stallard on his stimulating paper on adaptive enrichment designs with a continuous biomarker. Dr. Stallard details a framework for a large and interesting class of enrichment procedures. His work has motivated us to offer some thoughts in response. Dr. Stallard's strategy is to use the maximum of a test statistic over a set of possible threshold values to define the enriched population to be sampled in a second stage. This reminds us of procedures for identifying a change point, a biomarker value beyond which the effect of treatment is increased. For simplicity we focus our comments on Dr. Stallard's Rule 1 for selecting the second‐stage sampling threshold. Using this rule, we present the likelihood ratio approach for adaptive testing and compare it to Dr. Stallard's approach for a few scenarios.

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  • Nancy Flournoy & Sergey Tarima, 2023. "Discussion on “Adaptive enrichment designs with a continuous biomarker” by Nigel Stallard," Biometrics, The International Biometric Society, vol. 79(1), pages 31-35, March.
    • Handle: RePEc:bla:biomet:v:79:y:2023:i:1:p:31-35
    DOI: 10.1111/biom.13641
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    1. Sergey Tarima & Nancy Flournoy, 2019. "Asymptotic properties of maximum likelihood estimators with sample size recalculation," Statistical Papers, Springer, vol. 60(2), pages 373-394, April.
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