Two-stage enrichment clinical trial design with adjustment for misclassification in predictive biomarkers.
Sign Up to like & getrecommendations! Published in 2019 at "Statistics in medicine"
DOI: 10.1002/sim.8370
Abstract: A two-stage enrichment design is a type of adaptive design, which extends a stratified design with a futility analysis on the marker negative cohort at the first stage, and the second stage can be either… read more here.
Keywords: two stage; misclassification; stage enrichment; marker ... See more keywords
Design Considerations for Two Stage Enrichment Clinical Trials.
Sign Up to like & getrecommendations! Published in 2022 at "Biometrics"
DOI: 10.1111/biom.13805
Abstract: When there is a predictive biomarker, enrichment can focus the clinical trial on a benefiting subpopulation. We describe a two-stage enrichment design, in which the first stage is designed to efficiently estimate a threshold and… read more here.
Keywords: design considerations; sample size; biomarker; two stage ... See more keywords