中国食品药品监管Issue(4)：34-39,6.DOI:10.3969/j.issn.1673-5390.2026.04.004
"希望区域"方法用于临床试验样本量重新估计的一般考虑
Promising Zone Method for Sample Size Re-estimation in Clinical Trials:General Considerations
摘要
Abstract
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.关键词
希望区域/样本量重新估计/适应性设计/期中分析/临床试验Key words
promising zone/sample size re-estimation/adaptive design/interim analysis/clinical trial分类
医药卫生引用本文复制引用
王景朝,唐智敏,潘建红.."希望区域"方法用于临床试验样本量重新估计的一般考虑[J].中国食品药品监管,2026,(4):34-39,6.
