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Research on core assessment indicators for human use experience of traditional Chinese medicine based on Delphi method
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Kai ZHI1, Peng-li SU2, Jun LIU2, Ya-nan YU2, Bing LI3, Hai-yu XU4, Geng LI5, Chun-di SHEN6, Xing LIAO2, Hai-xia DANG1
Chinese Journal of New Drugs | 2023, 32(12) : 1201 - 1205
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Chinese Journal of New Drugs | 2023, 32(12): 1201-1205
Research on core assessment indicators for human use experience of traditional Chinese medicine based on Delphi method
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Kai ZHI1, Peng-li SU2, Jun LIU2, Ya-nan YU2, Bing LI3, Hai-yu XU4, Geng LI5, Chun-di SHEN6, Xing LIAO2, Hai-xia DANG1
Affiliations
  • 1China Academy of Chinese Medical Sciences, Beijing 100700, China
  • 2Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China
  • 3Institute of Chinese Materia Medica, China Academy of Chinese Medical Sciences, Beijing 100700, China
  • 4Research Center of Drug Regulatory Science, China Academy of Chinese Medical Sciences, Beijing 100700, China
  • 5Institute of Medicinal Plant Development, Chinese Academy of Medical Sciences, Beijing 100193, China
  • 6Nanjing University of Chinese Medicine, Nanjing 210023, China
Published: 2023-06-30
Outline
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Objective:

To scientifically construct the evaluation indicators for human use experience of traditional Chinese medicine (TCM) and provide reference for the formation of "triple combination" registration review evidence system.

Methods:

Based on the Delphi method, after literature research and expert investigation, two rounds of expert consultation were carried out, and the expert consultation results were evaluated by the mean, variation index, coordination coefficient, etc., and the core indicators for human use experience evaluation of TCM were further screened and optimized.

Results:

22 experts in various fields were selected to conduct a questionnaire survey. The participation rates of experts in the 2 rounds of consultation were 100% and 95.46%, and the authority indicators of involved experts were 0.852 and 0.865. According to the mean value and coefficient of variation of the indicators, combined with the revision suggestions of experts, the core indicators of human use experience evaluation including 4 first-level indicators and 22 second-level indicators were finally formed.

Conclusion:

The core indicators for human use experience evaluation of TCM could guide the standardized collection and summary of human use experience data, promote the formation of high-quality and evaluable human use experience evidence, and support the research and development of new TCM products.

traditional Chinese medicine  /  human use experience  /  evaluation indicators  /  Delphi method
Kai ZHI, Peng-li SU, Jun LIU, Ya-nan YU, Bing LI, Hai-yu XU, Geng LI, Chun-di SHEN, Xing LIAO, Hai-xia DANG. Research on core assessment indicators for human use experience of traditional Chinese medicine based on Delphi method[J]. Chinese Journal of New Drugs, 2023 , 32 (12) : 1201 -1205 .
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Article Info
  • Online Date：2026-03-06
  • Published：2023-06-30
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History
  • Accepted：2022-11-18
Funding
Affiliations
    1China Academy of Chinese Medical Sciences, Beijing 100700, China
    2Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China
    3Institute of Chinese Materia Medica, China Academy of Chinese Medical Sciences, Beijing 100700, China
    4Research Center of Drug Regulatory Science, China Academy of Chinese Medical Sciences, Beijing 100700, China
    5Institute of Medicinal Plant Development, Chinese Academy of Medical Sciences, Beijing 100193, China
    6Nanjing University of Chinese Medicine, Nanjing 210023, China
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