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A gated group sequential design for seamless Phase II/III trial with subpopulation selection.

Guanhong MiaoJason J Z LiaoJing YangKeaven Anderson
Published in: BMC medical research methodology (2023)
Combining the group sequential design and adaptive design, the gated group sequential design has more power and higher efficiency while controlling for the familywise error rate. It has the potential to save drug development cost and more quickly fulfill unmet medical needs.
Keyphrases
  • phase ii
  • clinical trial
  • open label
  • healthcare
  • phase iii
  • randomized controlled trial
  • study protocol
  • risk assessment
  • human health