Incorporating efficacy data from initial trials into subsequent evaluations of vaccines against respiratory syncytial virus.
Joshua L WarrenMaria E SundaramVirginia E PitzerSaad B OmerDaniel M WeinbergerPublished in: medRxiv : the preprint server for health sciences (2023)
Due to the need to control the type I error rate in trials used to license a vaccine, the incorporation of historical data provides little additional benefit in terms of stopping the trial early. However, these statistical approaches could be promising in evaluations that use real-world evidence following licensure.