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Comparing Go/No-Go Decision-Making Properties Between Single Arm Phase II Trial Designs in Oncology.

Kristine BroglioJayne MarshallBinbing YuPaul Frewer
Published in: Therapeutic innovation & regulatory science (2022)
The Multilevel approach provides flexibility in interpreting moderate efficacy results. However, the flexibility is accomplished with a lower sample size and corresponding uncertainty in the trial outcome that increases the risk of incorrect drug development decisions.
Keyphrases
  • decision making
  • phase iii
  • palliative care
  • open label
  • study protocol
  • clinical trial
  • phase ii
  • high intensity
  • randomized controlled trial