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Improved practice for diversity of drug clinical trial population in the United States and inspiration to China
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Tian-zhu ZENG, Jian-zhou YAN, Rong SHAO
Chinese Journal of New Drugs and Clinical Remedies | 2024, 43(10) : 759 - 764
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Chinese Journal of New Drugs and Clinical Remedies | 2024, 43(10): 759-764
• Policy and Management •
Improved practice for diversity of drug clinical trial population in the United States and inspiration to China
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Tian-zhu ZENG, Jian-zhou YAN, Rong SHAO
Affiliations
  • The Research Center of National Drug Policy & Ecosystem, China Pharmaceutical University, Nanjing JIANGSU 211198, China
Published: 2024-10-25 doi: 10.14109/j.cnki.xyylc.2024.10.06
Outline
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The diversity of clinical trial population is the key to ensure the generalizability of drug safety and efficacy assessment results obtained from clinical trials, and plays an important role in advancing research on new drugs and strengthening the regulation of marketed drugs to improve the quality of life for patients. The United States has accumulated rich experience in improving the diversity of clinical trial population. Regulatory authorities have established a policy system for improving research practice, reducing patient participation barriers, and promoting data collection and sharing, and have provided diversified clinical trial information to the public. Clinical trial institutions have promoted the participation of patients from different backgrounds in clinical trials by strengthening inter-agency cooperation, facilitating community involvement, and improving the cultural inclusiveness of employees. China can learn from the relevant experience of the United States, improve the supervision system of clinical trial population diversity, promote the capacity building of clinical trial institutions to serve diverse populations, and strengthen the publicity and education of clinical trials, so as to improve the diversity of clinical trial population.

clinical trial  /  population diversity  /  United States
曾添筑, 颜建周, 邵蓉. 美国药物临床试验人群多样性改善实践对我国的启示. 中国新药与临床杂志, 2024 , 43 (10) : 759 -764 . DOI: 10.14109/j.cnki.xyylc.2024.10.06
Tian-zhu ZENG, Jian-zhou YAN, Rong SHAO. Improved practice for diversity of drug clinical trial population in the United States and inspiration to China[J]. Chinese Journal of New Drugs and Clinical Remedies, 2024 , 43 (10) : 759 -764 . DOI: 10.14109/j.cnki.xyylc.2024.10.06
Year 2024 volume 43 Issue 10
668
334
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Article Info
doi: 10.14109/j.cnki.xyylc.2024.10.06
  • Receive Date:2023-12-11
  • Online Date:2026-03-17
  • Published:2024-10-25
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  • Received:2023-12-11
  • Accepted:2024-05-14
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    The Research Center of National Drug Policy & Ecosystem, China Pharmaceutical University, Nanjing JIANGSU 211198, 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
total species (%)
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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