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Clinical trials is a scientific experimental activity that needs thorough plan and strict execution. Investigators often expect to complete the trial according to the study plan. However, due to the uncertainty of disease mechanisms, the diversity of patients, and the complexity of interventions, trials usually cannot be executed exactly according to the established protocols. A comprehensive review of the implementation of registered clinical trials reveals that such situations are not uncommon and commonly include: the aim of the clinical trials is apparent inability to complete thus requiring termination of the trials; unexpected events, such as adverse reactions, policy changes, etc., leading to suspend the trial and adjust the trial protocol. However, research on this issue is limited, and there is no definite answer on the scientific understanding, reason analysis, and plan design. In this paper, we comprehensively review the factors related to the suspension and termination of clinical trials and try to propose a solution.

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临床试验是一项严密计划、严格执行的科学实验活动。研究者往往期望按照研究计划完成试验。但由于疾病机制的不确定性、受试对象的多样性、干预措施的复杂性等因素,试验通常无法完全按照既定方案执行。全面回顾已注册临床试验实施详情发现,此类情况并不少见,常见的包括:临床试验目的提前完成或者明显无法完成,需要终止试验;试验出现了意外事件,如受试者不良反应、政策变更等,需要暂停试验以调整试验方案。但前期学界对此问题缺少针对性研究,有关临床试验暂停与终止的科学认识、原因分析、预案设计等均无明确解答。本文全面梳理了临床试验暂停与终止的相关因素,并尝试提出解决路径。

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石康乐,女,在站博士后,主要从事基于系统复杂性的诊疗信息处理与评价研究。E-mail:
孟庆刚,男,教授,主任医师,主要从事基于系统复杂性的诊疗信息处理与评价研究。E-mail:
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王瑞坤,女,硕士研究生,主要从事基于系统复杂性的诊疗信息处理与评价研究。E-mail:

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王瑞坤,女,硕士研究生,主要从事基于系统复杂性的诊疗信息处理与评价研究。E-mail:

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王瑞坤,女,硕士研究生,主要从事基于系统复杂性的诊疗信息处理与评价研究。E-mail:

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药物临床试验暂停与终止问题探析
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王瑞坤 1 , 刘晓玉 1 , 石康乐 2 , 孟庆刚 1
中国新药杂志 | 药物临床试验规范与进展专栏 2023,32(21): 2173-2177
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中国新药杂志 | 药物临床试验规范与进展专栏 2023, 32(21): 2173-2177
药物临床试验暂停与终止问题探析
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王瑞坤1 , 刘晓玉1, 石康乐2 , 孟庆刚1
作者信息
  • 1北京中医药大学,北京 100029
  • 2中国科学院大学,北京 100049
  • 王瑞坤,女,硕士研究生,主要从事基于系统复杂性的诊疗信息处理与评价研究。E-mail:

通讯作者:

石康乐,女,在站博士后,主要从事基于系统复杂性的诊疗信息处理与评价研究。E-mail:
孟庆刚,男,教授,主任医师,主要从事基于系统复杂性的诊疗信息处理与评价研究。E-mail:
An analysis of the suspension and termination issues of clinical trials
Rui-kun WANG1 , Xiao-yu LIU1, Kang-le SHI2 , Qing-gang MENG1
Affiliations
  • 1Beijing University of Chinese Medicine, Beijing 100029, China
  • 2University of Chinese Academy of Sciences, Beijing 100049, China
出版时间: 2023-11-15
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临床试验是一项严密计划、严格执行的科学实验活动。研究者往往期望按照研究计划完成试验。但由于疾病机制的不确定性、受试对象的多样性、干预措施的复杂性等因素,试验通常无法完全按照既定方案执行。全面回顾已注册临床试验实施详情发现,此类情况并不少见,常见的包括:临床试验目的提前完成或者明显无法完成,需要终止试验;试验出现了意外事件,如受试者不良反应、政策变更等,需要暂停试验以调整试验方案。但前期学界对此问题缺少针对性研究,有关临床试验暂停与终止的科学认识、原因分析、预案设计等均无明确解答。本文全面梳理了临床试验暂停与终止的相关因素,并尝试提出解决路径。

临床试验方法  /  试验终止  /  试验暂停  /  预案设计  /  动态监测

Clinical trials is a scientific experimental activity that needs thorough plan and strict execution. Investigators often expect to complete the trial according to the study plan. However, due to the uncertainty of disease mechanisms, the diversity of patients, and the complexity of interventions, trials usually cannot be executed exactly according to the established protocols. A comprehensive review of the implementation of registered clinical trials reveals that such situations are not uncommon and commonly include: the aim of the clinical trials is apparent inability to complete thus requiring termination of the trials; unexpected events, such as adverse reactions, policy changes, etc., leading to suspend the trial and adjust the trial protocol. However, research on this issue is limited, and there is no definite answer on the scientific understanding, reason analysis, and plan design. In this paper, we comprehensively review the factors related to the suspension and termination of clinical trials and try to propose a solution.

clinical trial methods  /  trial termination  /  trial suspension  /  preplanning design  /  dynamic monitoring
王瑞坤, 刘晓玉, 石康乐, 孟庆刚. 药物临床试验暂停与终止问题探析. 中国新药杂志, 2023 , 32 (21) : 2173 -2177 .
Rui-kun WANG, Xiao-yu LIU, Kang-le SHI, Qing-gang MENG. An analysis of the suspension and termination issues of clinical trials[J]. Chinese Journal of New Drugs, 2023 , 32 (21) : 2173 -2177 .
  • 国家自然科学基金项目(82174530)
  • 中国科学院大学优秀青年教师科研能力提升项目(E0E48979)
2023年第32卷第21期
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  • 首发时间:2026-03-05
  • 出版时间:2023-11-15
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  • 录用日期:2022-10-20
基金
国家自然科学基金项目(82174530)
中国科学院大学优秀青年教师科研能力提升项目(E0E48979)
作者信息
    1北京中医药大学,北京 100029
    2中国科学院大学,北京 100049

通讯作者:

石康乐,女,在站博士后,主要从事基于系统复杂性的诊疗信息处理与评价研究。E-mail:
孟庆刚,男,教授,主任医师,主要从事基于系统复杂性的诊疗信息处理与评价研究。E-mail:
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2种不同金属材料的力学参数

Family
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Number of
genus
种数
Number of
species
占总种数比例
Percentage of
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Genus
种数
Number of
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占总种数比例
Percentage of total
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鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
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