中国中西医结合杂志2024，Vol.44Issue(12)：1425-1430,6.DOI:10.7661/j.cjim.20241107.251
中医药临床研究平台试验应用探索与思考
Exploration and Reflections on the Application of Platform Trials in Clinical Research of Chinese Medicine
摘要
Abstract
Platform trial is a clinical trial design model that simultaneously evaluates multiple treatment options within a single trial framework while allowing flexible adjustments during the trial to improve efficiency and optimize resources.The advantages of platform trials include facilitating the comparison of various interventions,reducing downtime between trials,and enabling long-term,dynamic evaluations of the optimal intervention for a specific disease.This article introduces the concept,principles,and methodological key points of platform trials,compares their design differences,advantages,and disadvantages with traditional clinical trials,and provides an in-depth analysis of the practical application of platform trials through the systematic therapy for advanced or metastatic prostate cancer:evaluation of drug efficacy(STAMPEDE)trial case.Additionally,it explores the potential advantages,challenges,and feasibility of applying platform trials in clinical research of Chinese medicine(CM)to promote innovation and development in CM clinicalresearch.关键词
平台试验/主方案设计/方法学/中医/临床研究Key words
platform trials/master protocol/methodology/Chinese medicine/clinical research引用本文复制引用
李恪丞,刘兆兰,王彬,施泽阳,卜志军,贺柏翔,黄圣,雷力行,王润泽,刘建平..中医药临床研究平台试验应用探索与思考[J].中国中西医结合杂志,2024,44(12):1425-1430,6.基金项目
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）
北京中医药大学后备学科带头人资助项目(No.90010960920033) （No.90010960920033）
