Abstract
Coronavirus disease 2019 (COVID-19) vaccine trials provide valuable insight into the safety and efficacy of vaccines, with individually randomized, placebo-controlled trials being the gold standard in trial design. However, a myriad of variables must be considered as clinical trial data are interpreted and used to guide policy decisions. These variables include factors such as the characteristics of the study population and circulating severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) strains, the force of infection, the definition and ascertainment of endpoints, the timing of vaccine efficacy assessment, and the potential for performance bias. In this Viewpoints article, we discuss critical variables to consider when comparing efficacy measurements across current and future COVID-19 vaccine trials.
Keywords: COVID-19; SARS-CoV-2; clinical trial; efficacy; vaccine.
【저자키워드】 COVID-19, SARS-CoV-2, Efficacy, Vaccine, clinical trial, 【초록키워드】 coronavirus disease, Coronavirus disease 2019, Vaccine, coronavirus, clinical trial, Trial, Vaccines, severe acute respiratory syndrome Coronavirus, Characteristics, placebo-controlled trial, gold, Strains, Critical, endpoints, Definition, acute respiratory syndrome, Factor, Placebo-controlled trials, acute respiratory syndrome coronavirus, acute respiratory syndrome coronavirus 2, study population, gold standard, ascertainment, COVID-19 vaccine trials, circulating, myriad, force, vaccine trial, variable, force of infection, include, individually randomized, the timing, 【제목키워드】 estimate, Better, Interpreting,