|
Abstract:
|
In biomarker-enrichment study designs that start with all-comer population, simultaneous evaluation of the entire and the marker-selected populations can be more desirable than pre-specifying the testing order, when the degree of marker predictiveness is uncertain. While there has been substantial research on this approach, our goal is to provide the complete overview and guidance in all aspects of this approach, including the interim analysis with potentially using different endpoint, combination tests with associated multiplicity control and the final treatment effect estimation. Regulatory/operational aspects and actual cases demonstrating potential advantage of this approach are also described.
|
