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

doi:10.19803/j.1672-8629.2021.07.07

Abstract

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

CLC Number:

R994.11

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.

References

[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.