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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 Weinberger
Published 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.
Keyphrases
  • respiratory syncytial virus
  • electronic health record
  • big data
  • clinical trial
  • randomized controlled trial
  • machine learning
  • artificial intelligence
  • placebo controlled