现代中医临床2024，Vol.31Issue(4)：39-43,5.DOI:10.3969/j.issn.2095-6606.2024.04.023
序贯多分配随机试验设计样本量估算方法及应用
Methodological research on sample size estimation methods for SMART design
摘要
Abstract
The Sequential Multi-Assignment Randomized Trial(SMART)design incorporates sequential and dynamic treatment strategies in clinical research.Determining an appropriate sample size poses a significant challenge in SMART studies.Sample size estimation methods for SMART design vary according to four primary research objective.Pilot studies,conducted as preparatory stages,primarily focus on precision and feasibility in sample size estimation.Estimating the main effects of first-line and second-line treatments in SMART design aligns with the commonly used sample size estimation methods in randomized controlled trials.Comparative analyses of embedded adaptive treatment measures encompass optimal adaptive treatment selection,paired dominance testing,paired non-inferiority testing,and multiple comparisons with the best-performing interventions.Sample size estimation for SMART designs aimed at developmental optimization primarily employs methods based on the normal distribution.This study aims to provide practical guidance and examples for sample size estimation in SMART designs,thereby advancing research in SMART design within the field of TCM.关键词
序贯多分配随机试验/样本量估算/SMART设计/辨证论治Key words
sequential multi-assignment randomized trial/sample size estimation/SMART design/pattern differentiation and treatment分类
医药卫生引用本文复制引用
卜志军,黄智芮,刘冯双,刘建平,刘兆兰,张雨欢,孙源,韩朝歌,王雪惠,徐耀宇,贺婷,陈婧如,李俊宏..序贯多分配随机试验设计样本量估算方法及应用[J].现代中医临床,2024,31(4):39-43,5.基金项目
国家自然科学基金项目(No.82374298) （No.82374298）
北京中医药大学学科后备带头人支持计划(No.90010960920033) （No.90010960920033）
国家中医药管理局高水平中医药重点学科建设项目(No.zyyzdxk-2023249) （No.zyyzdxk-2023249）
