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| Framework of estimands and its application in clinical trials of traditional Chinese medicine |
| Hits 534 Download times 557 Received:June 16, 2022 |
| View Full Text View/Add Comment Download reader |
| DOI
10.11656/j.issn.1672-1519.2022.10.12 |
| Key Words
E9(R1);estimands;clinical trial of traditional Chinese medicine;application |
| Author Name | Affiliation | E-mail | | CAI Qiuhan | Clinical Trial Center, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, National Clinical Research Center for Chinese Medicine Acupuncture and Moxibustion, Tianjin 300381, China | 胡思源，husiyuan1963@sina.com | | HU Siyuan | Clinical Trial Center, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, National Clinical Research Center for Chinese Medicine Acupuncture and Moxibustion, Tianjin 300381, China | | | ZHONG Chengliang | Clinical Trial Center, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, National Clinical Research Center for Chinese Medicine Acupuncture and Moxibustion, Tianjin 300381, China | | | GUO Shengxuan | Clinical Trial Center, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, National Clinical Research Center for Chinese Medicine Acupuncture and Moxibustion, Tianjin 300381, China | |
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| Abstract
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| ICH E9(R1) proposed a new concept of estimands to describe treatment effects more accurately,which is a practical tool to establish a close logical relationship among trial purpose,design,implementation,analysis and interpretation.In this paper,the application of estimands framework in the design of traditional Chinese medicine clinical trials were discussed from the aspects of the framework,the common intercurrent events and its treatment strategy in trials of traditional Chinese medicine,sensitivity and supplementary analysis,protocol with estimands. |
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