"希望区域"方法用于临床试验样本量重新估计的一般考虑OA

The use of sample size re-estimation based on interim data has increasing attention and has been widely adopted in China in recent years as a part of adaptive trial designs.Among the various methods that rigorously control the overall type Ⅰ error rate,the"promising zone"approach proposed by Mehta and Pocock has attracted considerable interest due to its notable advantages.However,this method also has certain inherent limitations.In practice,some sponsors have applied the"promising zone"approach without adequately assessing its applicability and feasibility,leading to potential misuse.This paper provides a literature review summarizing the strengths and limitations of the promising zone method.On this basis,key practical considerations for its implementation are proposed.This work aims to enhance stakeholders' understanding of the"promising zone"approach and to provide guidance for the scientifically sound and appropriate application of sample size re-estimation methods in clinical trials.