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Abstract:
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Adaptive design has the flexibility allowing pre-specified modifications to an ongoing trial to mitigate the potential risk associated with the assumptions made at the design stage. Our work is motivated by a Phase III event-driven vaccine efficacy trial. Two target patient populations are being enrolled with the assumption that vaccine efficacy can be demonstrated based on the two patient subpopulations combined. It is recognized due to the heterogeneity of the patient characteristics, the two subpopulations might respond to the vaccine differently. i.e., the vaccine efficacy (VE) in one population could be lower than that in the other. To maximize the probability of demonstrating vaccine efficacy in at least one patient population while taking advantage of combining two populations in one single trial, an adaptive design strategy with potential population enrichment is developed. Specifically, if the observed vaccine efficacy at interim for one subpopulation is not promising to warrant carrying forward, the enrollment in the other population can be enriched. A few statistical challenges for considerations will be discussed for this population enrichment design.
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