Adaptive design: overview

Design

Intro to adaptive design

Author

Chi Zhang

Published

August 26, 2023

Resources

Sequential design

Number of patient isn’t set in advance. A good group sequential design can reduce the sample size needed, while keeping the desired statistical power and controlling the overall type I error.

GSD includes pre-determined number of stages (interim, final). Each stage specified by

  • sample size
  • critical values
  • stopping criterion to support or reject null hypothesis

TBC

Basket and umbrella trials

Interview questions

  • Can you describe what an adaptive clinical trial design is and give an example of how it can be applied in oncology?
  • What are the advantages and disadvantages of adaptive trial designs compared to traditional fixed designs?
  • How would you adjust a trial protocol if interim analysis shows a promising treatment effect?