Sample size calculation for active-arm trial with counterfactual incidence based on recency assay.
Fei GaoDavid V GliddenJames P HughesDeborah J Donnell
Published in: Statistical communications in infectious diseases (2021)
Future one-arm trials with counterfactual placebo incidence based on a recency assay can be conducted with reasonable total screening sample sizes and adequate power to determine treatment efficacy.