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BASIC: A Bayesian adaptive synthetic-control design for phase II clinical trials.

Liyun JiangPeter F ThallFangrong YanScott KopetzYing Yuan
Published in: Clinical trials (London, England) (2023)
The Bayesian adaptive synthetic-control design provides a useful tool for exploiting historical control data to improve the efficiency of single-arm phase II clinical trials, while addressing the problem of bias when comparing trial results to historical control data. The proposed design achieves power similar to a randomized controlled trial but may require a substantially smaller sample size.
Keyphrases
  • phase ii
  • clinical trial
  • open label
  • phase iii
  • double blind
  • placebo controlled
  • big data
  • electronic health record