The statistical power and validity of Ebola vaccine trials in Sierra Leone: A simulation study of trial design and analysis

摘要

BackgroundSafe and effective vaccines may help end the ongoing Ebola virus disease (EVD) epidemic in West Africa, and mitigate future outbreaks. We evaluate the statistical validity and power of randomized controlled (RCT) and stepped-wedge cluster trial (SWCT) designs in Sierra Leone, where EVD incidence is spatiotemporally heterogeneous, and rapidly declining.