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Using simulated infectious disease outbreaks to inform site selection and sample size for individually randomized vaccine trials during an ongoing epidemic.

Zachary J MadewellAna Pastore Y PionttiQian ZhangNathan BurtonYang YangIra M LonginiM Elizabeth HalloranAlessandro VespignaniNatalie E Dean
Published in: Clinical trials (London, England) (2021)
Mathematical and statistical models may assist in designing successful vaccination trials by capturing uncertainty and correlation in future transmission. Although many factors affect site selection, such as logistical feasibility, models can help investigators optimize site selection and the number and size of participating sites. Although our study focused on trial design for an emerging arbovirus, a similar approach can be made for any infectious disease with the appropriate model for the particular disease.
Keyphrases
  • infectious diseases
  • phase iii
  • phase ii
  • open label
  • study protocol
  • randomized controlled trial
  • placebo controlled