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Abstract:
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With rapid development of biotechnologies, predictive markers or selection markers are increasingly used in drug clinical trials in subgroups of patients in which treatment decisions or patient management can be different. Enrichment design may be used in the clinical trials to evaluate the drug efficacy. Even though many clinical trials have used enrichment design, what is the estimand in the evaluation is not typically discussed or explicitly derived. In this presentation, we will derive the estimand in the enrichment design in evaluating predictive or selection markers. We will also discuss the relationship of the estimand in the enrichment design to other designs, e.g. marker-strategy or all-comer design.
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