Clinical comprehensive evaluation system of drugs: a systematic review_Chinese Journal of Evidence-Based Medicine

Authors：

DAI Zeqi , JING Chengyang , WU Xue , ZHANG Le ,  LIAO Xing

Center for Evidence-based Chinese Medicine, Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, P. R. China;

Corresponding author：

LIAO Xing, Email: okfrom2008@hotmail.com

Keywords：

Clinical comprehensive evaluation of drug; Value assessment; Evaluation system; Chinese patent medicine

DOI：

10.7507/1672-2531.202302039

Video：

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Objective To systematically review the studies on the clinical comprehensive evaluation system of drugs at home and abroad. Methods The PubMed, EMbase, Cochrane Library, CNKI, WanFang Data, VIP and CBM databases were electronically searched to collect the literature and policy documents of the clinical comprehensive evaluation system of drugs from inception to October 31, 2022. The evaluation organization, evaluation perspective, application scope, domains and criteria were sorted out, and the evaluation of different types of drugs was analyzed in detail. Results A total of 101 clinical comprehensive evaluation systems of drugs were included. The publishing time was from 2009 to 2022, and the number of published articles increased. The first author mainly came from 26 countries, including China (n=34), Canada (n=11), the United States (n=10), and Spain (n=10). Forty-seven articles reported the evaluation perspective. All evaluation systems could be used for drug evaluation, of which 43 could be used as universal evaluation tools, and 58 could be used for the evaluation of specific drugs, mainly including anti-tumor drugs (n=15), orphan drugs (n=10) and traditional Chinese medicine (n=7). The number of evaluation domains varied from 2 to 22, and the number of criteria varied from 4 to 56. Among them, economics (n=73), effectiveness (n=72), safety (n=54), disease demand/burden (n=34), and innovation (n=24) were the most frequent evaluation domains. Conclusion The research on clinical comprehensive evaluation of drugs at home and abroad has grown up. During the implementation of clinical comprehensive evaluation of Chinese patent medicine, it is necessary to clarify the evaluation perspective, define the evaluation scope, and determine the evaluation domains.

Citation： DAI Zeqi, JING Chengyang, WU Xue, ZHANG Le, LIAO Xing. Clinical comprehensive evaluation system of drugs: a systematic review. Chinese Journal of Evidence-Based Medicine, 2023, 23(7): 776-782. doi: 10.7507/1672-2531.202302039 Copy

1.	Zhang M, Bao Y, Lang Y, et al. What is value in health and healthcare. A systematic literature review of value assessment frameworks. Value Health, 2022, 25(2): 302-317.
2.	国家卫生健康委办公厅. 关于规范开展药品临床综合评价工作的通知. 中华人民共和国国家卫生健康委员会公报, 2021, (7): 21-28.
3.	国家药物和卫生技术综合评估中心. 关于心血管病、抗肿瘤、儿童药品临床综合评价技术指南公开征求意见的公告. 2021.
4.	Institute of Medicine (US) Roundtable on Value & Science-Driven Health Care. Value in health care: accounting for cost, quality, safety, outcomes, and innovation. Washington (DC): National Academies Press (US), 2010.
5.	元唯安, 张俊华, 刘建平, 等. 中成药临床综合评价指南(2022年版试行). 中国中药杂志, 2023, 48(1): 256-264.
6.	中国中医科学院中医临床基础医学研究所, 北京中医药大学东直门医院, 中华医学会杂志社指南与标准研究中心, 等. 多维度多准则中成药综合评价技术指导原则. 中国循证医学杂志, 2022, 22(7): 751-755.
7.	张强, 王志飞, 谢雁鸣, 等. 中成药临床综合评价技术规范. 世界中医药, 2021, 16(22): 3394-3397, 3403.
8.	束雅春, 田磊, 谭喜莹. 医疗机构中成药品种遴选与临床应用评价指标体系构建江苏专家共识. 中国药房, 2022, 33(2): 129-135.
9.	程杰, 关胜江, 曹俊岭, 等. 医疗机构中成药遴选专家共识(第一版). 中国药学杂志, 2022, 57(18): 1580-1586.
10.	党海霞, 刘骏, 李兵, 等. 中成药价值评估指标体系研究. 中国新药杂志, 2021, 30(11): 961-970.
11.	王绚, 张永, 许静. 基于德尔菲法构建中药注射剂上市后再评价指标体系. 中国医院药学杂志, 2021, 41(1): 85-88.
12.	石秀园. 我国药品临床综合评价认知现状及决策转化影响因素研究. 昆明: 昆明医科大学, 2021.
13.	杨萍, 鲁松, 董宪喆, 等. 药品综合评价方法研究进展. 中国药物警戒, 2022, 19(7): 803-806.
14.	国家卫生健康委药物政策与基本药物制度司. 药品临床综合评价管理指南(2021年版试行).
15.	王海银, 符雨嫣, 覃肖潇, 等. 药品临床综合评价: 保障临床基本用药合理使用. 中国卫生, 2021, (8): 72-73.
16.	赵琨. 我国药品临床综合评价从管理走向技术规范. 国家卫生健康委卫生发展研究中心官网, 2022.
17.	Lakdawalla DN, Doshi JA, Garrison LP, et al. Defining elements of value in health care-a health economics approach: an ISPOR special task force report [3]. Value Health, 2018, 21(2): 131-139.
18.	Goetghebeur MM, Cellier MS. Can reflective multicriteria be the new paradigm for healthcare decision-making. The EVIDEM journey. Cost Eff Resour Alloc, 2018, 16(Suppl 1): 54.
19.	石秀园, 赵锐, 李璠, 等. 构建我国药品临床综合评价工作机制的思考. 中国药房, 2020, 31(23): 2828-2833.
20.	郎驿天, 柴青青, 廖雅慧, 等. 国内外抗肿瘤药物临床价值评估体系比较. 中国药房, 2022, 33(11): 1287-1294.
21.	刘鑫, 唐彦, 左玮, 等. 国外孤儿药综合评价概述及启示. 临床药物治疗杂志, 2020, 18(6): 85-88.
22.	北京协和医院罕见病多学科协作组, 中国罕见病联盟. 多准则决策分析应用于罕见病药品临床综合评价的专家共识(2022). 协和医学杂志, 2022, 13(2): 235-254.
23.	Sussex J, Rollet P, Garau M, et al. A pilot study of multicriteria decision analysis for valuing orphan medicines. Value Health, 2013, 16(8): 1163-1169.
24.	Friedmann C, Levy P, Hensel P, et al. Using multi-criteria decision analysis to appraise orphan drugs: a systematic review. Expert Rev Pharmacoecon Outcomes Res, 2018, 18(2): 135-146.
25.	尚俊美, 刘鑫, 陈丽萌, 等. 多准则决策分析在孤儿药综合评价中的应用进展. 中国药学杂志, 2021, 56(22): 1785-1790.
26.	Westrich K, Buelt L. Current landscape: value assessment frameworks. 2020.
27.	NCCN. Clinical practice guidelines in oncology (NCCN guidelines) with NCCN evidence blocks. 2023.
28.	刘雨晨, 吴斌. 国外抗肿瘤药物价值评估体系的概述. 临床肿瘤学杂志, 2018, 23(5): 472-475.
29.	Schnipper LE, Davidson NE, Wollins DS, et al. Updating the American society of clinical oncology value framework: revisions and reflections in response to comments received. J Clin Oncol, 2016, 34(24): 2925-2934.
30.	Avalere. Patient-perspective value framework (PPVF) version 1.0. 2017.
31.	郭武栋. 如何“以价值论英雄”. 中国卫生, 2019, (10): 79-81.
32.	廖星, 郭武栋, 曹庄, 等. 应用卫生技术评估开展中成药临床综合评价. 中国中药杂志, 2020, 45(16): 3749-3758.

1. Zhang M, Bao Y, Lang Y, et al. What is value in health and healthcare. A systematic literature review of value assessment frameworks. Value Health, 2022, 25(2): 302-317.
2. 国家卫生健康委办公厅. 关于规范开展药品临床综合评价工作的通知. 中华人民共和国国家卫生健康委员会公报, 2021, (7): 21-28.
3. 国家药物和卫生技术综合评估中心. 关于心血管病、抗肿瘤、儿童药品临床综合评价技术指南公开征求意见的公告. 2021.
4. Institute of Medicine (US) Roundtable on Value & Science-Driven Health Care. Value in health care: accounting for cost, quality, safety, outcomes, and innovation. Washington (DC): National Academies Press (US), 2010.
5. 元唯安, 张俊华, 刘建平, 等. 中成药临床综合评价指南(2022年版试行). 中国中药杂志, 2023, 48(1): 256-264.
6. 中国中医科学院中医临床基础医学研究所, 北京中医药大学东直门医院, 中华医学会杂志社指南与标准研究中心, 等. 多维度多准则中成药综合评价技术指导原则. 中国循证医学杂志, 2022, 22(7): 751-755.
7. 张强, 王志飞, 谢雁鸣, 等. 中成药临床综合评价技术规范. 世界中医药, 2021, 16(22): 3394-3397, 3403.
8. 束雅春, 田磊, 谭喜莹. 医疗机构中成药品种遴选与临床应用评价指标体系构建江苏专家共识. 中国药房, 2022, 33(2): 129-135.
9. 程杰, 关胜江, 曹俊岭, 等. 医疗机构中成药遴选专家共识(第一版). 中国药学杂志, 2022, 57(18): 1580-1586.
10. 党海霞, 刘骏, 李兵, 等. 中成药价值评估指标体系研究. 中国新药杂志, 2021, 30(11): 961-970.
11. 王绚, 张永, 许静. 基于德尔菲法构建中药注射剂上市后再评价指标体系. 中国医院药学杂志, 2021, 41(1): 85-88.
12. 石秀园. 我国药品临床综合评价认知现状及决策转化影响因素研究. 昆明: 昆明医科大学, 2021.
13. 杨萍, 鲁松, 董宪喆, 等. 药品综合评价方法研究进展. 中国药物警戒, 2022, 19(7): 803-806.
14. 国家卫生健康委药物政策与基本药物制度司. 药品临床综合评价管理指南(2021年版试行).
15. 王海银, 符雨嫣, 覃肖潇, 等. 药品临床综合评价: 保障临床基本用药合理使用. 中国卫生, 2021, (8): 72-73.
16. 赵琨. 我国药品临床综合评价从管理走向技术规范. 国家卫生健康委卫生发展研究中心官网, 2022.
17. Lakdawalla DN, Doshi JA, Garrison LP, et al. Defining elements of value in health care-a health economics approach: an ISPOR special task force report [3]. Value Health, 2018, 21(2): 131-139.
18. Goetghebeur MM, Cellier MS. Can reflective multicriteria be the new paradigm for healthcare decision-making. The EVIDEM journey. Cost Eff Resour Alloc, 2018, 16(Suppl 1): 54.
19. 石秀园, 赵锐, 李璠, 等. 构建我国药品临床综合评价工作机制的思考. 中国药房, 2020, 31(23): 2828-2833.
20. 郎驿天, 柴青青, 廖雅慧, 等. 国内外抗肿瘤药物临床价值评估体系比较. 中国药房, 2022, 33(11): 1287-1294.
21. 刘鑫, 唐彦, 左玮, 等. 国外孤儿药综合评价概述及启示. 临床药物治疗杂志, 2020, 18(6): 85-88.
22. 北京协和医院罕见病多学科协作组, 中国罕见病联盟. 多准则决策分析应用于罕见病药品临床综合评价的专家共识(2022). 协和医学杂志, 2022, 13(2): 235-254.
23. Sussex J, Rollet P, Garau M, et al. A pilot study of multicriteria decision analysis for valuing orphan medicines. Value Health, 2013, 16(8): 1163-1169.
24. Friedmann C, Levy P, Hensel P, et al. Using multi-criteria decision analysis to appraise orphan drugs: a systematic review. Expert Rev Pharmacoecon Outcomes Res, 2018, 18(2): 135-146.
25. 尚俊美, 刘鑫, 陈丽萌, 等. 多准则决策分析在孤儿药综合评价中的应用进展. 中国药学杂志, 2021, 56(22): 1785-1790.
26. Westrich K, Buelt L. Current landscape: value assessment frameworks. 2020.
27. NCCN. Clinical practice guidelines in oncology (NCCN guidelines) with NCCN evidence blocks. 2023.
28. 刘雨晨, 吴斌. 国外抗肿瘤药物价值评估体系的概述. 临床肿瘤学杂志, 2018, 23(5): 472-475.
29. Schnipper LE, Davidson NE, Wollins DS, et al. Updating the American society of clinical oncology value framework: revisions and reflections in response to comments received. J Clin Oncol, 2016, 34(24): 2925-2934.
30. Avalere. Patient-perspective value framework (PPVF) version 1.0. 2017.
31. 郭武栋. 如何“以价值论英雄”. 中国卫生, 2019, (10): 79-81.
32. 廖星, 郭武栋, 曹庄, 等. 应用卫生技术评估开展中成药临床综合评价. 中国中药杂志, 2020, 45(16): 3749-3758.

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