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中医药临床研究平台试验应用探索与思考

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平台试验是指在同一试验框架内同时评估多种治疗方案,并在试验过程中灵活调整,以提高效率和优化资源的一种临床试验设计模式.平台试验的优势是便于实现多种干预措施的比较,降低试验间停顿时间,长期、动态评估某一疾病的最佳干预方案.笔者介绍了平台试验的概念、原理、方法学要点,比较与传统临床试验的设计差异以及优缺点,并通过评估晚期或转移性前列腺癌的多种药物治疗方法疗效(STAMPEDE)试验的具体案例分析,详细说明平台试验的实际应用情况,同时探究平台试验在中医药临床研究中应用的优势与挑战,以期推动中医药临床研究的创新发展.
Exploration and Reflections on the Application of Platform Trials in Clinical Research of Chinese Medicine
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.

platform trialsmaster protocolmethodologyChinese medicineclinical research

李恪丞、王彬、施泽阳、卜志军、贺柏翔、黄圣、雷力行、王润泽、刘建平、刘兆兰

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北京中医药大学东直门医院男科(北京 100700)

北京中医药大学第一临床医学院(北京 100070)

北京中医药大学循证医学中心(北京 100029)

北京中医药大学东直门医院脾胃科(北京 100700)

北京中医药大学东直门医院肾病内分泌科(北京 100700)

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平台试验 主方案设计 方法学 中医 临床研究

2024

中国中西医结合杂志
中国中西医结合学会 中国中医科学院

中国中西医结合杂志

CSTPCD北大核心
影响因子:2.149
ISSN:1003-5370
年,卷(期):2024.44(12)