Formulate technical guidance for real-world studies of traditional Chinese medicine in China to promote the transformation of clinical research of Chinese patent medicine into decision evidence_Chinese Journal of Evidence-Based Medicine

Authors：

 SUN Xin ¹ , ZHANG Junhua ² , WANG Wen ¹ , TAN Jing ¹ , PENG Xiaoxia ³ , GAO Pei ⁴ , WU Jing ⁵ , WEN Zehuai ⁶ , LUO Jianfeng ⁷ , LI Ling ¹ , LI Lei ⁸ , HUANG Shiyao ¹ , QI Yana ¹ , LI Youping ¹ , ZHANG Boli ² , On Behalf of Real World Research Professional Committee of China Association of Traditional Chinese Medicine

1. Chinese Evidence-based Medicine Center, West China Hospital, Sichuan University, Chengdu 610041, P.R.China;
2. Evidence-based Medicine Center, Tianjin University, Tianjin 300072, P.R.China;
3. Center for Clinical Epidemiology and Evidence-based Medicine, Beijing Children’s Hospital, Capital Medical University, Beijing 100045, P.R.China;
4. Department of Epidemiology and Biostatistics, Peking University Health Science Center, Beijing 100191, P.R.China;
5. School of Pharmacology Science and Technology, Tianjin University, Tianjin 300072, P.R.China;
6. Key Unit of Methodology in Clinical Research, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou 510120, P.R.China;
7. Department of Biostatistics, School of Public Health, Fudan University, Shanghai 200032, P.R.China;
8. Technic Center of Pharmaceutical Research and Evaluation, China Association of Traditional Chinese Medicine, Beijing 100061, P.R.China;

Corresponding author：

SUN Xin, Email: sunx79@hotmail.com

Keywords：

Traditional Chinese medicine; Real-world study; Technical guidance

DOI：

10.7507/1672-2531.202006027

Video：

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Abstract Full text Figures/Tables Video References Cited by

Traditional Chinese medicine (TCM) has a long history. In the process of fighting against diseases, TCM has formed a unique theoretical system and the way to think and diagnose. The holistic thinking, and the treatment according to syndrome differentiation are the most prominent characteristics of TCM, which matches with advanced medical concept and direction. The clinical efficacy has always been the basis for the advancement of TCM. However, issues such as the lagging behind of modern research on the evaluation of TCM curative effect, as well as lacking high-quality scientific research evidence, impede the development and promotion of the TCM toward the world. To address the above problems, recent progress in real-word study (RWS) has provided the opportunity for TCM researches, especially for the post-marketing evaluation of Chinese patent medicine (CPM). The formulation of this technical guidance for RWS of CPM is helpful to researchers in carrying out standardized, reasonable and scientific researches, to improve the quality of production and use of real-word evidence, and to promote the advancement of the TCM industry.

Citation： SUN Xin, ZHANG Junhua, WANG Wen, TAN Jing, PENG Xiaoxia, GAO Pei, WU Jing, WEN Zehuai, LUO Jianfeng, LI Ling, LI Lei, HUANG Shiyao, QI Yana, LI Youping, ZHANG Boli, On Behalf of Real World Research Professional Committee of China Association of Traditional Chinese Medicine. Formulate technical guidance for real-world studies of traditional Chinese medicine in China to promote the transformation of clinical research of Chinese patent medicine into decision evidence. Chinese Journal of Evidence-Based Medicine, 2020, 20(9): 993-999. doi: 10.7507/1672-2531.202006027 Copy

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5.	孙鑫, 谭婧, 王雯, 等. 建立真实世界数据与研究技术规范, 促进中国真实世界证据的生产与使用. 中国循证医学杂志, 2019, 19(7): 755-762.
6.	王雯, 高培, 吴晶, 等. 构建基于既有健康医疗数据的研究型数据库技术规范. 中国循证医学杂志, 2019, 19(7): 763-770.
7.	谭婧, 程亮亮, 王雯, 等. 患者登记研究的策划与患者登记数据库构建: 基于观察性设计的真实世界研究. 中国循证医学杂志, 2017, 17(12): 1365-1372.
8.	彭晓霞, 舒啸尘, 谭婧, 等. 基于真实世界数据评价治疗结局的观察性研究设计技术规范. 中国循证医学杂志, 2019, 19(7): 779-786.
9.	Ford I, Norrie J. Pragmatic trials. N Engl J Med, 2016, 375(5): 454-463.
10.	青雪梅, 房繄恭, 刘保延, 等. 实用性随机对照试验及其方法学特征思考. 北京中医药大学学报, 2008, (1): 14-18.
11.	Berger ML, Dreyer N, Anderson F, <italic>et al</italic>. Prospective observational studies to assess comparative effectiveness: the ISPOR good research practices task force report. Value Health, 2012, 15(2): 217-230.
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1. Berger ML, Mamdani M, Atkins D, <italic>et al</italic>. Good research practices for comparative effectiveness research: defining, reporting and interpreting nonrandomized studies of treatment effects using secondary data sources: the ISPOR good research practices for retrospective database analysis task force report-part I. Value Health, 2009, 12(8): 1044-1052.
2. 中国医师协会中西医结合医师分会, 中国中西医结合学会循证医学专业委员会. 中医药与中西医结合临床研究方法指南. 中国中西医结合杂志, 2015, 35(8): 901-932.
3. Cheng CW, Wu TX, Shang HC, <italic>et al</italic>. CONSORT extension for Chinese herbal medicine formulas 2017: recommendations, explanation, and elaboration. Ann Intern Med, 2017, 167(2): W7-W20.
4. 李洪, 魏来, 郭晓蕙, 等. 真实世界研究伦理审查初探. 中国循证医学杂志, 2018, 18(11): 1198-1202.
5. 孙鑫, 谭婧, 王雯, 等. 建立真实世界数据与研究技术规范, 促进中国真实世界证据的生产与使用. 中国循证医学杂志, 2019, 19(7): 755-762.
6. 王雯, 高培, 吴晶, 等. 构建基于既有健康医疗数据的研究型数据库技术规范. 中国循证医学杂志, 2019, 19(7): 763-770.
7. 谭婧, 程亮亮, 王雯, 等. 患者登记研究的策划与患者登记数据库构建: 基于观察性设计的真实世界研究. 中国循证医学杂志, 2017, 17(12): 1365-1372.
8. 彭晓霞, 舒啸尘, 谭婧, 等. 基于真实世界数据评价治疗结局的观察性研究设计技术规范. 中国循证医学杂志, 2019, 19(7): 779-786.
9. Ford I, Norrie J. Pragmatic trials. N Engl J Med, 2016, 375(5): 454-463.
10. 青雪梅, 房繄恭, 刘保延, 等. 实用性随机对照试验及其方法学特征思考. 北京中医药大学学报, 2008, (1): 14-18.
11. Berger ML, Dreyer N, Anderson F, <italic>et al</italic>. Prospective observational studies to assess comparative effectiveness: the ISPOR good research practices task force report. Value Health, 2012, 15(2): 217-230.
12. Liljas B. How to calculate indirect costs in economic evaluations. Pharmacoeconomics, 1998, 13(1 Pt 1): 1-7.

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Chinese Journal of Evidence-Based Medicine

Formulate technical guidance for real-world studies of traditional Chinese medicine in China to promote the transformation of clinical research of Chinese patent medicine into decision evidence

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