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Consideration about the design and implementation of blinding in the new traditional Chinese medicine clinical trials
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Cai-mei SONG
Chinese Journal of Clinical Pharmacology | 2025, 41(21) : 3139 - 3142
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Chinese Journal of Clinical Pharmacology | 2025, 41(21): 3139-3142
• Drug Evaluation and Administration •
Consideration about the design and implementation of blinding in the new traditional Chinese medicine clinical trials
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Cai-mei SONG
Affiliations
  • Center for Drug Evaluation, National Medical Products Administration, Beijing 100076, China
Published: 2025-11-17 doi: 10.13699/j.cnki.1001-6821.2025.21.023
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Randomisation, controll and blinding are classic designs for drug clinical trials. This article introduced the classification and implementation of blinding, and the particularity of blinding in traditional Chinese medicine clinical trials. Then discussed some concerns about design and implementation of blinding in traditional Chinese medicine clinical trials, such as, should pay attention to the similarity evaluation of placebo, and should design the protocol and process based on the similarity of the placebo, and some problems about the blinding in the dose-finding trails and the packaging and label of investigational product.

new traditional Chinese medicine  /  clinical trial  /  blind  /  placebo  /  similarity evaluation  /  packaging and label
宋彩梅. 中药新药临床试验中盲法设计与实施的思考. 中国临床药理学杂志, 2025 , 41 (21) : 3139 -3142 . DOI: 10.13699/j.cnki.1001-6821.2025.21.023
Cai-mei SONG. Consideration about the design and implementation of blinding in the new traditional Chinese medicine clinical trials[J]. Chinese Journal of Clinical Pharmacology, 2025 , 41 (21) : 3139 -3142 . DOI: 10.13699/j.cnki.1001-6821.2025.21.023
Year 2025 volume 41 Issue 21
315
90
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doi: 10.13699/j.cnki.1001-6821.2025.21.023
  • Receive Date:2025-06-11
  • Online Date:2026-08-05
  • Published:2025-11-17
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  • Received:2025-06-11
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    Center for Drug Evaluation, National Medical Products Administration, Beijing 100076, China
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表12种不同金属材料的力学参数
科
Family
属数
Number of
genus
种数
Number of
species
占总种数比例
Percentage of
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属
Genus
种数
Number of
species
占总种数比例
Percentage of total
species (%)
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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