真实世界证据在上市后药品安全性监测与评价中的应用价值

doi:10.19803/j.1672-8629.2021.07.06

中国药物警戒 ›› 2021, Vol. 18 ›› Issue (7): 624-627.
DOI: 10.19803/j.1672-8629.2021.07.06

• 真实世界数据与上市药品的安全性监测和评价专栏 • 上一篇下一篇

真实世界证据在上市后药品安全性监测与评价中的应用价值

孟若谷¹, 卓琳², 乔瑞^2,3, 刘玉强^2,4, 孙凤^5,*, 詹思延^2,5#

¹北京大学健康医疗大数据国家研究院, 北京 100191;
²北京大学第三医院临床流行病学研究中心, 北京 100191;
³内蒙古科技大学包头医学院社会医学与卫生事业管理教研室, 内蒙古包头 014040;
⁴山西省长治市人民医院药剂科, 山西长治 046000;
⁵北京大学公共卫生学院, 北京 100191

收稿日期:2021-03-31 出版日期:2021-07-15 发布日期:2021-07-23
通讯作者: ^*孙凤,女,副教授·博导,循证医学与药物流行病学。E-mail: sunfeng@bjmu.edu.cn;^#为共同通讯作者。
作者简介:孟若谷,女,博士,助理研究员,慢性病流行病学与健康数据科学。
基金资助:
国家自然科学基金资助项目（72074011、82003536）; 国家药品监督管理局中国药品监管科学行动计划重点项目（CDRZ20193027）

Application Values of Real-World Evidence in Post-Marketing Surveillances and Evaluation for Drug Safety

MENG Ruogu¹, ZHUO Lin², QIAO Rui^2,3, LIU Yuqiang^2,4, SUN Feng^5,*, ZHAN Siyan^2,5#

¹National Institute of Health Data Science, Peking University, Beijing 100191; China;
²Research Center of Clinical Epidemiology, Peking University Third Hospital, Beijing 100191, China;
³Department of Social Medicine and Health Management, Baotou Medical College, Baotou 014040, China;
⁴Department of Pharmacy, Changzhi People's Hospital, Changzhi 046000, China;
⁵School of Public Health, Peking University, Beijing 100191, China

Received:2021-03-31 Online:2021-07-15 Published:2021-07-23

摘要/Abstract

摘要： 目的了解真实世界证据(real world evidence, RWE)在上市后药品安全性监测与评价中的应用价值。方法检索PubMed、Embase、Web of Science、Scopus、中国生物医学文献服务系统、中国知网、维普网、万方数据建库至2020年1月2日中与RWE及上市后药品安全性相关的文献,归纳RWE应用价值。结果及结论 经课题组讨论和专家咨询将RWE在上市后药品安全性监测与评价中的应用价值,归纳为补充药品安全性证据、辅助药品上市后管理、支持临床决策及卫生政策、技术方法开发优化4个方面,并提供参考案例。

关键词: 真实世界证据, 上市后药品监测与评价, 药品安全

Abstract: Objective To understand the application values of real-world evidence (RWE) in post-marketing surveillance and evaluation for drug safety. Methods Literatures related to RWE in post-marketing surveillance for drug safety were searched in PubMed, Embase, Web of Science, Scopus, SinoMed, CNKI, VIP, Wanfang Data from the establishment to January 2, 2020. Results and conclusion After research team and expert consultation, application values of RWE in post-marketing surveillance and evaluation for drug safety was summarized into four aspects, including supplementing drug safety evidence, auxiliary drug post-marketing management, supporting clinical decision-making and health policies, as well as technical methods development and optimization. And for each aspect reference cases were provided.

Key words: real world evidence, post-marketing surveillance, drug safety

中图分类号:

R994.11

孟若谷, 卓琳, 乔瑞, 刘玉强, 孙凤, 詹思延. 真实世界证据在上市后药品安全性监测与评价中的应用价值[J]. 中国药物警戒, 2021, 18(7): 624-627.

MENG Ruogu, ZHUO Lin, QIAO Rui, LIU Yuqiang, SUN Feng, ZHAN Siyan. Application Values of Real-World Evidence in Post-Marketing Surveillances and Evaluation for Drug Safety[J]. Chinese Journal of Pharmacovigilance, 2021, 18(7): 624-627.

参考文献

[1] Sherman RE, Anderson SA, Dal Pan GJ, et al.Real-world evidence — what is it and what can it tell us?[J]. N Engl J Med, 2016, 375(23): 2293-2297.
[2] United States of America Congress. 21st century cures act[EB/OL]. (2016-12-13)[2021-03-05]. https://www.congress.gov/114/plaws/publ255/PLAW-114publ255.pdf.
[3] Food and Drug Administration. Framework for FDA’s real-world evidence program[EB/OL]. (2018-12-01)[2021-03-05]. https://www.fda.gov/media/120060/download.
[4] Food and Drug Administration. Use of real-world evidence to support regulatory decision-making for medical devices: draft guidance for industry and Food and Drug Administration staff[EB/OL]. (2017-08-31)[2021-03-05]. https://www.fda.gov/media/99447/download.
[5] Food and Drug Administration. Use of electronic health records in clinical investigations[EB/OL]. (2018-07-01)[2021-03-05]. https://www.fda.gov/media/97567/download.
[6] Food and Drug Administration. Submitting documents utilizing real-world data and real-world evidence to FDA for drugs and biologics[EB/OL]. (2019-05-01)[2021-03-05]. https://www.fda.gov/media/124795/download.
[7] National Medical Products Administration. Guiding principles of real-world evidence supporting drug development and evaluation (trial implementation)[EB/OL]. (2020-01-03)[2021-03-05]. https://www.nmpa.gov.cn/yaopin/ypggtg/ypqtgg/20200107151901190.html.
[8] Center for Drug Evaluation of National Medical Products Admini-stration. Technical guiding principles of real-world study supporting the development and evaluation of children's drugs (trial implementation)[EB/OL]. (2020-08-27)[2021-03-05]. https://www.nmpa.gov.cn/xxgk/ggtg/qtggtg/20200901104448101.html.
[9] Vinogradova Y, Coupland C, Hill T, et al.Risks and benefits of direct oral anticoagulants versus warfarin in a real world setting: cohort study in primary care[J]. British Medical Journal, 2018, 362: k2505.
[10] Wang SC, Liu BY, Xiong NN, et al.Discussion on solutions to ethical issues of clinical researches in a real world[J]. Chinese Journal of Integrated Traditional and Western Medicine(中国中西医结合杂志), 2013, 33(04): 437-442.
[11] Zhang NN, Shi HX, Zhou HW, et al.Characterisrics of TCM real-world research[J]. Modernization of Traditional Chinese Medicine and Materia Medica-World Science and Technology(世界科学技术·中医现代化), 2018, 20(9): 1496-1500.
[12] Platt R, Brown JS, Robb M, et al.The FDA Sentinel Initiative - an evolving national resource[J]. N Engl J Med, 2018, 379(22):2091-2093.
[13] Taylor LG, Panucci G, Mosholder AD, et al.Antipsychotic use and stroke: a retrospective comparative study in a non-elderly population[J]. J Clin Psychiatry, 2019, 80(4): m12636.
[14] Eworuke E, Welch EC, Tobenkin A, et al.Use of FDA's Sentinel System to quantify seizure risk immediately following new ranolazine exposure[J]. Drug Saf, 2019, 42(7): 897-906.
[15] Li J, Panucci G, Moeny D, et al.Association of risk for venous thromboembolism with use of low-dose extended and continuous-cycle combined oral contraceptives: a safety study using the Sentinel Distributed Database[J]. JAMA Intern Med, 2018, 178(11): 1482-1488.
[16] Mack CD, Dreyer NA, Bosco J, et al.Using real-world evidence to inform decision making[J]. Chin J Pharmacoepidemiol(药物流行病学杂志), 2014, 23(1): 17-28.
[17] Xuan JW, Cheng J, Xue XF, et al.Real world medical database construction and its applications on hospital management, clinical diagnosis and treatment, rational medicine use, and meticulous management of medical insurance[J]. China Journal of Pharmaceutical Economics(中国药物经济学), 2019, 14(5): 10-17.
[18] Zhao H, Wei L, Li H, et al. Appropriateness of antibiotic prescriptions in ambulatory care in China: a nationwide descriptive database study[J]. Lancet Infect Dis, 2021, 3099(20): 30596-X.
[19] Luo JM, Wu J, Chen SN, et al.Impact analysis on disease management cost of nilotinib as first-line treatment for chronic myeloid leukemia in China[J]. Chin Heal Insur(中国医疗保险), 2018(4): 59-65.
[20] Adisasmito W, Chan PK, Lee N, et al.Effectiveness of antiviral treatment in human influenza A (H5N1) infections: analysis of a global patient registry[J]. J Infect Dis, 2010, 202(8): 1154-1160.
[21] Chan PK, Lee N, Zaman M, et al.Determinants of antiviral effectiveness in influenza virus a subtype H5N1[J]. J Infect Dis, 2012, 206(9): 1359-1366.
[22] Oner AF, Dogan N, Gasimov V, et al.H5N1 avian influenza in children[J]. Clin Infect Dis, 2012, 55(1): 26-32.
[23] Adisasmito W, Aisyah DN, Aditama TY, et al.Human influenza A H5N1 in Indonesia: health care service-associated delays in treatment initiation[J]. BMC Public Health, 2013, 13: 571.
[24] Chen SB, Yu F.Suggestions on the development of real world study on the rare diseases and orphan drugs[J]. Journal of International Pharmaceutical Research(国际药学研究杂志), 2019, 46(9): 699-704.
[25] Guan J.The value and potential risk of real world evidence with ethical considerations[J]. Med Phil(医学与哲学), 2017, 38(10) : 27-30.

真实世界证据在上市后药品安全性监测与评价中的应用价值

Application Values of Real-World Evidence in Post-Marketing Surveillances and Evaluation for Drug Safety

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