Comparing Go/No-Go Decision-Making Properties Between Single Arm Phase II Trial Designs in Oncology.
Kristine BroglioJayne MarshallBinbing YuPaul FrewerPublished 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.