推动建立临床试验协作与共享机制——疫情蔓延期的战略思考  

Promoting Establishment of a Collaboration and Sharing Mechanism on Clinical Trials: Strategic Thinking During Epidemic Spread Period

作　　者：张晓雨[1,2] 赵晨 孙杨 魏旭煦 关曼柯 赵梦竹 林繄依 商洪才 ZHANG Xiaoyu;ZHAO Chen;SUN Yang;WEI Xuxu;GUAN Manke;ZHAO Mengzhu;LIN Yiyi;SHANG Hongcai(Dongzhimen Hospital,Beijing University of Chinese Medicine,Beijing,100700;School of Traditional Chinese Medicine,Beijing University of Chinese Medicine;Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences;The First Teaching Hospital of Tianjin University of Traditional Chinese Medicine;International Institute of Evidencebased Traditional Chinese Medicine,Beijing University of Chinese Medicine)

机构地区：[1]北京中医药大学东直门医院,北京市100700 [2]北京中医药大学中医学院 [3]中国中医科学院中医临床基础医学研究所,北京市1007003 [4]天津中医药大学第一附属医院 [5]北京中医药大学国际循证中医药研究院,北京市100700

出　　处：《中医杂志》2020年第8期650-654,共5页Journal of Traditional Chinese Medicine

基　　金：国家自然科学基金(81725024)。

摘　　要：自新型冠状病毒肺炎疫情暴发以来,在中国临床试验注册中心、美国临床试验注册中心、中国中医药循证医学中心临床研究注册平台共注册了相关临床试验70个,涉及疾病筛查、诊断、预防、治疗、预后康复等多领域,但同时也暴露了存在重复性研究、竞争临床资源,主要指标差异较大、研究目的不明确、难以对结果进行比较,样本量设置依据不足,基本概念混淆,临床研究设计有待提高等问题。为增强应对突发公共卫生事件研究的能力,提出推动建立临床试验协作与共享机制的策略,并从推进临床试验信息共享、加强临床试验总体监管、完善临床试验应急机制、组织临床试验高水平团队四个方面提出相关建议。Since the outbreak of COVID-19, 70 relevant clinical trials have been registered in Chinese Clinical Trial Register, ClinicalTrials.gov and Clinical Trial Registration Platform of China Center for Evidence-based Medicine of Traditional Chinese Medicine, focusing on multiple fields including disease screening, diagnosis, prevention, treatment, prognosis and rehabilitation. But at the same time, it also exposed some problems, such as research competing for clinical resources, large difference in major indicators without clear research objectives, difficult for comparison on results, lack of basis for setting sample, confusion in basic concepts, clinical study design requiring improvement. In order to enhance the ability to respond to public health emergencies, this paper proposes a strategy to promote establishment of clinical trial collaboration and sharing mechanism, and also puts forward relevant suggestions from four aspects including promoting information sharing on clinical trials, strengthening the overall supervision on clinical trials, improving the emergency response mechanism of clinical trials and organizing high-level team for clinical trials.

关 键 词：新型冠状病毒肺炎 临床试验注册 信息共享 应急机制 中医药研究 

分 类 号：R288[医药卫生—中药学]