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An analysis of the suspension and termination issues of clinical trials
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Rui-kun WANG1, Xiao-yu LIU1, Kang-le SHI2, Qing-gang MENG1
Chinese Journal of New Drugs | 2023, 32(21) : 2173 - 2177
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Chinese Journal of New Drugs | 2023, 32(21): 2173-2177
An analysis of the suspension and termination issues of clinical trials
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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
Published: 2023-11-15
Outline
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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.

clinical trial methods  /  trial termination  /  trial suspension  /  preplanning design  /  dynamic monitoring
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 .
Year 2023 volume 32 Issue 21
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Article Info
  • Online Date:2026-03-05
  • Published:2023-11-15
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  • Accepted:2022-10-20
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Affiliations
    1Beijing University of Chinese Medicine, Beijing 100029, China
    2University of Chinese Academy of Sciences, Beijing 100049, China
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表12种不同金属材料的力学参数

Family
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Number of
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Number of
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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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