Imbalanced Randomization in Vaccine Clinical Safety Trials

Clinical safety and immunogenicity data in vaccines are commonly dichotomized into responder and nonresponder binary data. This article expands upon Fagerland, Lyndersen, and Laake to further study Newcombe’s hybrid score and Fisher’s conditional exact test using imbalanced randomization in vaccine clinical studies. The intent of this article is to study a potential statistical issue in clinical study design and analysis; hence, no reference to any particular product is made.</p

Supplement_Inconsistency_Examples_26Jun - Lessons Learned From Multi-regional Trials With Signals of Treatment Effect Heterogeneity

Supplement_Inconsistency_Examples_26Jun for Lessons Learned From Multi-regional Trials With Signals of Treatment Effect Heterogeneity by Gang Li, Hui Quan, Gordon Lan, Soo Peter Ouyang, Fei Chen, Weining Robieson, William Wang, Bruce Binkowitz, Shuai Sammy Yuan, Yoko Tanaka, Josh Chen, Nobushige Matsuoka, Lanju Zhang, Song Yang, and Paul Gallo in Therapeutic Innovation & Regulatory Science</p