肿瘤防治研究2025，Vol.52Issue(12)：1029-1034,6.DOI:10.3971/j.issn.1000-8578.2025.25.0555
抗肿瘤药物临床试验适应性设计的应用
Application of Adaptive Designs Used in Clinical Trials of Anti-Cancer Drugs
摘要
Abstract
Clinical trials of anti-cancer drugs are characterized by long cycles,high risks,large investments,complex efficacy evaluations,and numerous influencing factors.Traditional experimental design is slow in progress and high in cost,which to some extent increases the uncertainty of research.With the guidance of domestic and international policies and the development of clinical trial methodologies,adaptive design has emerged.Flexible adaptive designs can shorten the clinical trial time of anti-cancer drugs,which is conducive to the discovery of truly effective anti-cancer drugs and therapies,thereby increasing the efficiency and success rate of new drug research and development.Starting from the characteristics of clinical trials of anti-cancer drugs,this article reviews the adaptive designs adopted in current clinical trials,summarizes the characteristics and differences of various adaptive design methods by introducing specific research and development cases,and discusses the problems and challenges faced.This work aims to provide methodological references for clinical trials of anti-cancer drugs.关键词
抗肿瘤药物/临床试验/新药研发/适应性设计Key words
Anti-cancer drugs/Clinical trials/New drug development/Adaptive design分类
医药卫生引用本文复制引用
王肇聪,戴助,梁新军..抗肿瘤药物临床试验适应性设计的应用[J].肿瘤防治研究,2025,52(12):1029-1034,6.基金项目
Special Research Fund Project of Biomedical Center,Hubei Cancer Hospital(No.2022SWZX04) 湖北省肿瘤医院生物医学中心专项科研基金(2022SWZX04) （No.2022SWZX04）
