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中文摘要：
受试者依从性是保证临床试验质量的关键因素.大型临床试验因协作单位多、纳入样本大、观察周期长,常导致受试者依从性较差.本文分析了临床试验中影响受试者依从性的常见因素并结合国家中医药行业科研专项--芪参益气滴丸治疗冠心病心力衰竭的临床评价研究（CACT-IHF）,对大样本、多中心随机双盲对照试验中受试者依从性的影响因素及保障措施进行了阐述
英文摘要：
The compliance of subjects is a key factor for ensuring the quality of clinical trials. A large- scale clinical trial often induces poor compliance of subjects as many participant units, large sample size and long observation period. The paper analyzed the common influencing factors on the compliance of subjects in clinical trials, and expounded the influencing factors and supporting measures in large-sample, multi-center, randomized, double-blind controlled trials combining the study on the clinical assessment of complementary treatment with Qishen Yiqi Gutta Pills on ischemic heart failure （ CACT-IHF ） , a scientific research of State Administration of Traditional Chinese Medicine.
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