Wanying Ma, Mengya Liu, Jian Zhu, Qing Li, Elaine Hoffman, Jianchang Lin
In vaccine clinical trials, vaccine efficacy endpoint analysis is usually associated with in high cost or extended study duration, due to the generally low infection rate. Correlate of protection (CoP), which refers to surrogate endpoint, usually immunological response, that can reliably predict the treatment effect, provides a more efficient and less costly approach to evaluate the vaccine. To handle the challenge of the missingness in the unobserved surrogate immune biomarker, the pseudo-score (PS) method, semiparametric method and pseudo-likelihood (PL) method demonstrated their advantages on different aspects...
May 29, 2023: Statistics in Medicine