A 2-Stage Phase II Design with Direct Assignment Option in Stage II for Initial Marker Validation
A 2-Stage Phase II Design with Direct Assignment Option in Stage II for Initial Marker Validation
Biomarkers are critical to targeted therapies, as they may identify patients more likely to benefit from a treatment. Several prospective designs for biomarker-directed therapy have been previously proposed, differing primarily in the study population, randomization scheme, or both. Recognizing the need for randomization, yet acknowledging the possibility of promising but …