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| Influencing factors of recruitment of clinical trial subjects in traditional Chinese medicine research and analysis |
| Hits 1506 Download times 973 Received:December 25, 2019 |
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| DOI
10.11656/j.issn.1673-9043.2020.01.14 |
| Key Words
clinical trials;subject recruitment;traditional Chinese medicine;ethic |
| Author Name | Affiliation | E-mail | | KONG Weijia | Beijing Chinese Medical University, Beijing 100029, China | | | CHEN Jiaqi | Beijing Chinese Medical University, Beijing 100029, China | | | ZHANG Chuhan | Beijing Chinese Medical University, Beijing 100029, China | | | ZHANG Shuang | Beijing Chinese Medical University, Beijing 100029, China | | | LI Dongsheng | Beijing Chinese Medical University, Beijing 100029, China | | | HAN Mei | Beijing Chinese Medical University, Beijing 100029, China | hanmeizoujin@163.com |
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| Abstract
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| [Objective] Recruitment of subjects is the most difficult and challenging but necessary speed limit in drug clinical research. There are many factors influencing the recruitment of subjects,including trial protocols and incentives. There is relatively little information on the recruitment of traditional Chinese medicine (TCM) clinical trial subjects. This study used questionnaires to analyze the potential factors affecting the subjects of TCM clinical trials,and tried to explore more effective clinical recruitment methods for TCM clinics to provide guidance for the recruitment of TCM clinical subjects.[Methods] For July-August 2018,400 outpatients from three top three hospitals of Beijing University of Chinese Medicine were surveyed.[Results] Multivariate results showed that the trial protocol,the side effects of Chinese medicine,the incentive compensation measures,the degree of trust of the subjects in the implementation of the research doctors and the hospital reputation were the main factors affecting whether the subjects were willing to participate in the trial (P<0.05).[Conclusion] The degree of cognition,the realization of rights and the trust between doctors and patients in the clinical trials of Chinese medicine practitioners are the main factors affecting the recruitment of clinical subjects in Chinese medicine. The relevant medicines should be popularized to the subjects through new media and other forms. Measures to fully recruit the rights of the subjects and enhance communication between doctors and patients to improve the recruitment of clinical trial subjects in Chinese medicine. |
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