Multi-stage enrichment and basket trial designs with population selection.
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DOI: 10.1002/sim.8371
Abstract: As biomarker information from early-phase trials can be unreliable due to high variability, it is logical to take a prospective two-stage approach when designing a late-phase confirmatory trial, ie, refining the target population at the… read more here.
Keywords: trial; population selection; designs population; stage ... See more keywords
Interim decision-making strategies in adaptive designs for population selection using time-to-event endpoints
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DOI: 10.1080/10543406.2016.1148714
Abstract: ABSTRACT Adaptive designs in oncology clinical trials with interim analyses for population selection could be used in the development of targeted therapies if a predefined biomarker hypothesis exists. In this article, we consider an interim… read more here.
Keywords: decision; population selection; adaptive designs; decision making ... See more keywords