Design considerations for Factorial Adaptive Multi-Arm Multi-Stage (FAST) clinical trials
A Phase II/III FAST design with 2 interim assessments and a final assessment examines the impact of interim assessments' timing on final operating characteristics. The Phase II portion includes arm-dropping and feasibility analyses, while the Phase III portion involves a generalized linear model with a gatekeeping procedure to control type 1 error.
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Design considerations for Factorial Adaptive Multi-Arm Multi-Stage (FAST) clinical trials
A Phase II/III FAST design with 2 interim assessments and a final assessment examines the impact of interim assessments' timing on final operating characteristics. The Phase II portion includes arm-dropping and feasibility analyses, while the Phase III portion involves a generalized linear model with a gatekeeping procedure to control type 1 error.