Abstract:In clinical trials, a correlate (surrogate) of protection (CoP) endpoint must be properly validated through rigorous sound methods before it may be approved for use. The validation of surrogate in the context of high vaccine efficacy trials, however, poses great challenge due to sparse data; and conventional methods for statistical validation of surrogate are no longer adequate. Although idea of surrogacy was developed in the context of a single trial, the meta-analytic approach, which allows both individual a… Show more
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