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A Practical Perspective: Application of the Generalized Approach for Adaptive Design.

Jin WangJuanjuan LiYu ShuXiaolu Su
Published in: Therapeutic innovation & regulatory science (2020)
The proposed adaptive approach is easy to implement in general sample size re-estimation situations. Its validity can be verified through simulation under varying scenarios. In summary, this approach offers a transparent communication channel with regulatory agencies to facilitate clinical trial development regardless of the complexity of the underlying situations.
Keyphrases
  • clinical trial
  • climate change
  • transcription factor
  • phase ii
  • open label
  • virtual reality