真实世界数据在上市后药品安全性研究中的伦理风险

doi:10.19803/j.1672-8629.2021.07.07

中国药物警戒 ›› 2021, Vol. 18 ›› Issue (7): 628-631.
DOI: 10.19803/j.1672-8629.2021.07.07

• 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

真实世界数据在上市后药品安全性研究中的伦理风险

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

¹北京大学第三医院临床流行病学研究中心,北京 100191;
²长治市人民医院药学部,山西长治 046000;
³内蒙古科技大学包头医学院公共卫生学院,内蒙古包头 014040;
⁴北京大学健康医疗大数据国家研究院,北京 100191;
⁵北京大学公共卫生学院,北京100191

收稿日期:2021-04-08 出版日期:2021-07-15 发布日期:2021-07-23
通讯作者: ^*孙凤,女,博士,教授·博导,循证医学与药物流行病学,E-mail：sunfeng@bjmu.edu.cn;^#为共同通信作者。
作者简介:刘玉强,男,在读博士,主管药师,医院药学与药物流行病学。
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）

Ethical Risks of Real-World Data in Post-Marketing Drug Safety Studies

LIU Yuqiang^1,2, QIAO Rui^1,3, ZHUO Lin¹, MENG Ruogu⁴, SUN Feng^5,*, ZHAN Siyan^1,5#

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

Received:2021-04-08 Online:2021-07-15 Published:2021-07-23

摘要/Abstract

摘要： 目的为更好地利用符合伦理要求的真实世界数据（real-world data, RWD）开展上市后药品安全性监测和评价。方法从患者安全和数据安全的维度出发,探讨RWD在研究方案中的伦理要求、研究注册和发表的伦理要求、以及数据归属和数据使用权限的伦理考虑。结果与结论 建议对真实世界研究（real-world study, RWS）中伦理问题立法并制定政策,同时加强对RWD伦理审查形式创新等相关问题的研究。

关键词: 上市后药品监测, 数据利用, 伦理要求, 伦理治理, 真实世界数据, 真实世界研究

Abstract: Objective To provide a reference for making better use of real-world data (RWD) ethical requirements to carry out post-marketing drug safety monitoring and evaluation. Methods From the perspective of patient safety and data security, discuss the ethical requirements of RWD in the research protocol, the ethical requirements of research registration and publication, and the ethical considerations of data ownership and data usage permissions. Results and Conclusion It is recommended to legislate and formulate policies on ethical issues in real-world study (RWS), and at the same time strengthen research on related issues such as the innovation of RWD ethical review forms.

Key words: post-marketing drug monitoring, data utilization, ethical requirement, ethical governance, real-world data, real-world study

中图分类号:

R994.11

刘玉强, 乔瑞, 卓琳, 孟若谷, 孙凤, 詹思延. 真实世界数据在上市后药品安全性研究中的伦理风险[J]. 中国药物警戒, 2021, 18(7): 628-631.

LIU Yuqiang, QIAO Rui, ZHUO Lin, MENG Ruogu, SUN Feng, ZHAN Siyan. Ethical Risks of Real-World Data in Post-Marketing Drug Safety Studies[J]. Chinese Journal of Pharmacovigilance, 2021, 18(7): 628-631.

参考文献

[1] General Office of the CPC Central Committee Office of the State Council. Opinions on deepening the reform of the review and approval system and encouraging innovation in drugs and medical devices[Z/OL].(2017-10-08)[2021-03-01].http://www.gov.cn/zhengce/2017-10/08/content_5230105.htm.
[2] Charter R, Yeung A, Smith M, et al.The Assessment of value for medical devices: using real world evidence(RWE) to quantify unmet needs in diabetes management[J]. Value in Health, 2016, 19(7): 703.
[3] WMA. Declaration of helsinki,ethical principles for medical research involving human subjects[EB/OL]. (2013)[2021-03-01]. https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/.
[4] CIOMS. International ethical guidelines for health-related research involving humans[EB/OL]. (2016)[2021-03-01]. https://cioms.ch/publications/product/international-ethical-guidelines-for-health-related-research-involving-humans/.
[5] International Society of Pharmacoepidemiology. Data privacy, medical record confidentiality, and research in the interest of public health[EB/OL].[2021-03-01]. https://www.pharmacoepi.org/resources/policies/privacy/.
[6] Guan J.Ethical requirements and management standards for the sharing and re-use of scientific data in healthcare and medicine (VII) expert consensus of ethical review guideline[J]. Chinese Medical Ethics(中国医学伦理学),2020, 33(10): 1159-1166.
[7] Chinese Pharmaceutical Association Standards. Guide on methodological standards in pharmacoepidemiology[J]. Chin J Pharmacoepidemiol(药物流行病学杂志), 2019, 28(10): 695-700.
[8] Laine C, Horton R, DeAngelis CD, et al. Clinical trial registration looking back and moving ahead[J]. Lancet, 2007, 369(9577): 1909-1911.
[9] Williams RJ, Tse T, Harlan WR, et al.Registration of observational studies: is it time?[J]. Canadian Medical Association Journal, 2010, 182(15): 1638-1642.
[10] Yao HZ, Sun MY, Gao R, et al.Discussion on ethics issues of real world study based on CIOMS guidelines[J]. Chinese Medical Ethics(中国医学伦理学), 2019, 32(5): 559-563.
[11] Public Policy Committee, International Society of Pharmaco-epidemiology. Guidelines for good pharmacoepidemiology practice (GPP)[J]. Pharmacoepidemiology and Drug Safety, 2016, 25(1): 2-10.
[12] Shan AL, Jiang YF.Similarities and differences of new drug phase Ⅳ clinical trials and post-marketing drug evaluation as well as existing problems[J]. Chin J Clin Pharmacol(中国临床药理学杂志), 2014, 30(5): 387-390,396.
[13] Zhang XW, Zhang HX, Zhu W.Ethic guidans for health data research in the 2016 version of CIOMS ethical guideline[J]. Medicine Philosophy(医学与哲学), 2019, 40(11): 9-12.
[14] Song HM, Liu BY, He LY, et al.Data mining requirements and data pre-processing methods based on the integration of Chinese medicine clinical scientific research[J]. Chinese Journal of Basic Medicine in Traditional Chinese Medicine(中国中医基础医学杂志), 2011, 17(12): 1323-1325.
[15] Xia W, Heatherly R, Ding X, et al.R-U policy frontiers forhealth data deidentification[J]. J Am Med Inform Assoc, 2015, 22(5): 1029-1041.
[16] Zhou YJ, Hong M.Ethical requirements of the hospital technology construction[J]. Chinese Medical Ethics(中国医学伦理学), 2010, 23(3): 109-111.
[17] 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(4): 437-442.
[18] Guan J.The value and potential risk of real world evidence with ethical considerations[J]. Medicine Philosophy(医学与哲学), 2017, 38(10): 27-30.
[19] Privacy and Health Research: A Report to the US Secretary of Health and Human Services from William W. Lowrance. May, 1997[EB/OL]. [2021-03-01]. http://aspe.os.dhhs.gov/datacncl/PHR.htm.
[20] Zhang HH, Yao C, Li HY.Ethical challenges and the ethical review of real world study[J]. China Food & Drug Administration Magazine(中国食品药品监管), 2020(11): 56-63.

真实世界数据在上市后药品安全性研究中的伦理风险

Ethical Risks of Real-World Data in Post-Marketing Drug Safety Studies

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