Biostatistics Seminar Series - Devan V. Mehrotra, PhD

Title: Clinical Endpoints for Evaluating Efficacy in COVID-19 Vaccine TrialsAbstract: Several candidate vaccines to protect against SARS-CoV-2 infection or COVID-19 disease have entered or will soon enter large-scale phase 3 placebo-controlled randomized clinical trials. To facilitate a harmonized evaluation and comparison of the efficacy of these vaccines, a core set of clinical endpoints is proposed, along with considerations to guide selection of the primary endpoint(s) based on clinical and statistical reasoning. The plausibility that vaccine protection against symptomatic COVID-19 could be accompanied by a shift towards more SARS-CoV-2 infections that are asymptomatic, and its potential implications, are highlighted. An illustrative example with hypothetical data is used to reinforce the main messages. (This is joint work with several biostatisticians, clinicians and infectious disease experts from academic centers, government and industry.)