国外药品获益-风险评价方法概述与启示

doi:10.19803/j.1672-8629.20240129

中国药物警戒 ›› 2024, Vol. 21 ›› Issue (8): 900-905.
DOI: 10.19803/j.1672-8629.20240129

国外药品获益-风险评价方法概述与启示

魏芬芳, 吴文宇, 李丽敏, 唐碧雨, 吴建茹^*

深圳市药物警戒和风险管理研究院,广东深圳 518000

收稿日期:2024-02-29 出版日期:2024-08-15 发布日期:2024-08-21
通讯作者: ^*吴建茹,女,博士,副主任药师,流行病与卫生统计学。E-mail: wujr@mail.amr.sz.gov.cn
作者简介:魏芬芳,女,硕士,主管药师,药事管理。
基金资助:
广东省自然科学基金资助项目（2023A1515011495）; 深圳市自然科学基金资助项目（JCYJ20230807150659006）; 广东省药品监督管理局科技创新项目（2021TDB06、2022TDB16）

Foreign methods for benefit-risk assessment of pharmaceutical products

WEI Fenfang, WU Wenyu, LI Limin, TANG Biyu, WU Jianru^*

Shenzhen Institute of Pharmacovigilance and Risk Management, Shenzhen Guangdong 518000, China

Received:2024-02-29 Online:2024-08-15 Published:2024-08-21

摘要/Abstract

摘要： 目的进一步了解国外有关药品获益-风险评价方法,比较优劣势,为我国相关工作提供参考。方法查阅国外有关药品获益-风险评价方法的文献和其他公开资料,对相关方法进行对比分析。结果梳理出国外研究理论上适用于监管决策的7种定性评价方法和18种定量方法,并搜集相关案例进行适应性研究,并提出促进我国药品获益-风险评价方法的相关建议。结论部分方法适用性较强,建议我国明确药品获益-风险评价框架;在定性评价框架下开发使用定量评价方法;明确获益-风险的比较标准;构建全面的数据采集网络。

关键词: 药物警戒, 药品, 获益, 风险, 评价, 药品不良反应

Abstract: Objective To find out more about foreign benefit-risk assessment methods of drugs and to provide reference for related work in China via a comparison of their advantages and disadvantages. Methods Foreign literature and other publicly available information on benefit-risk assessment methods for pharmaceuticals were reviewed and analyzed. Results Seven qualitative methods and 18 quantitative methods were identified that could be used for regulatory decision-making from theories on research abroad, and related cases were collected for adaptive research, as well as, recommendations to promote benefit-risk evaluation methodology for medicines in China were made. Conclusion Some of the methods are highly applicable. It is recommended that the framework of benefit-risk assessment of drugs be specified in China, quantitative evaluation methods be established within a qualitative evaluation framework, the standard for comparison of benefits and risks be set, and a comprehensive data collection network be constructed in China.

Key words: pharmacovigilance, drug, benefit, risk, assessment, adverse drug reactions

中图分类号:

R951
R994.11

魏芬芳, 吴文宇, 李丽敏, 唐碧雨, 吴建茹. 国外药品获益-风险评价方法概述与启示[J]. 中国药物警戒, 2024, 21(8): 900-905.

WEI Fenfang, WU Wenyu, LI Limin, TANG Biyu, WU Jianru. Foreign methods for benefit-risk assessment of pharmaceutical products[J]. Chinese Journal of Pharmacovigilance, 2024, 21(8): 900-905.

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参考文献

[1] XIAO HL.Introduction to FDA’s guidance on benefit-risk assessment of new drugs and biologics for corporate use[J]. Drug Evaluation Research(药物评价研究), 2022, 45(2): 210-220.
[2] ZUO SN, HE CL, ZHAO JZ.Benefit-risk assessment in drug evaluation[J]. The Chinese Journal of Clinical Pharmacology(中国临床药理学杂志), 2021, 37(13): 1757-1763.
[3] LEONG J, MCAUSLANE N, WALKER S, et al.Is there a need for a universal benefit-risk assessment framework for medicines? Regulatory and industry perspectives[J]. Pharmacoepidemiology & Drug Safety, 2013, 22(9): 1004-1012.
[4] HUNINK MG, GLASZIOU PP, SIEGEL JE, et al.Decision Making in Health and Medicine[M]. British: Cambridge University Press, 2014: 446.
[5] LEVITAN BS, ANDREWS EB, GILSENAN A, et al.Application of the BRAT framework to case studies: observations and insights[J]. Clinical Pharmacology & Therapeutics, 2011, 89(2): 217-224.
[6] WALKER S, MCAUSLANE N, LEONG J.A universal framework for the benefit-risk assessment of medicines: is this the way forward?[J]. Therapeutic Innovation & Regulatory Science, 2015, 49(1): 17-25.
[7] GUO ZJ, HU FY, ZHENG Y, et al.Quantitative drug benefit-risk evaluation methodology research and implications[J]. Chinese Journal of Pharmacovigilance(中国药物警戒), 2021, 18(7): 649-654.
[8] XIONG WY, DONG D.A risk evaluation method for pharmaceutical benefit based on multi-criteria decision analysis modeling[J]. Chinese Journal of Pharmacovigilance(中国药物警戒), 2017, 14(12): 752-754.
[9] THOKALA P, DEVLIN N, MARSH K, et al.Multiple criteria decision analysis for health care decision making-an introduction: report 1 of the ISPOR MCDA Emerging Good Practices Task Force[J]. Value in Health, 2016, 19(1): 1-13.
[10] ZENG BQ, YU SQ, GAO L, et al.Current status and application of benefit-risk modeling in pharmacoepidemiology[J]. Chinese Journal of Pharmacoepidemiology(药物流行病学杂志), 2022, 31(10): 686-693.
[11] THOMPSON JP, NOYES K, DORSEY ER, et al.Quantitative risk-benefit analysis of natalizumab[J]. Neurology, 2008, 71(5): 357-364.
[12] LARRY D. LYND AB, BERNIE J.Advances in risk-benefit evaluation using probabilistic simulation methods: an application to the prophylaxis of deep vein thrombosis[J]. Journal of Clinical Epidemiolog, 2004, 57: 795-803.
[13] NMPA. Circular of the Center for Drug Review of the State Drug Administration on the Publication of the Technical Guidelines on Benefit-Risk Assessment of New Drugs(No. 36 of2023)[EB/OL]. (2023-06-25)[2023-07-21]. https://www.cde.org.cn/main/news/viewInfoCommon/cf70af12d88f6068a9fcbb11b7d8db6b.
[14] NMPA. Technical Guidelines for Patient-Centered Drug Benefit-Risk Assessment (Trial)[EB/OL]. (2023-07-27)[2023-11-06]. https://www.cde.org.cn/zdyz/domesticinfopage?zdyzIdCODE=c5ed3f3c040266a64f15e0cc5fd95c22.
[15] TIAN CH, WU GZ.Regular benefit-risk assessment reporting reflections on implementation in China[J]. Chinese Journal of Pharmacovigilance(中国药物警戒), 2023, 20(12): 1382-1384, 1395.
[16] WANG XY, DONG JP.Clinical development and risk-benefit assessment of rare disease drug belintuzumab and implications[J]. Drug Evaluation Research(药物评价研究), 2022, 45(4): 618-623.

国外药品获益-风险评价方法概述与启示

Foreign methods for benefit-risk assessment of pharmaceutical products

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