A Practical Perspective: Application of the Generalized Approach for Adaptive Design.
Jin WangJuanjuan LiYu ShuXiaolu SuPublished 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.