新药临床试验中安全性报告管理

中国药物警戒 ›› 2019, Vol. 16 ›› Issue (2): 88-93.

新药临床试验中安全性报告管理

刘欢¹, 张钟艺¹, 杨悦^1,2,*

1 沈阳药科大学工商管理学院,辽宁沈阳 110016;
2 沈阳药科大学国际食品药品政策与法律研究中心,辽宁沈阳 110016

收稿日期:2019-03-12 修回日期:2019-03-12 出版日期:2019-02-25 发布日期:2019-03-12
作者简介:刘欢,女,在读硕士,药事管理。

Safety Report Management in New Drug Clinical Trials

LIU Huan¹, ZHANG Zhongyi¹, YANG Yue^1,2,*

1 School of Business Administration, Shenyang Pharmaceutical University, Liaoning Shenyang 110016, China;
2 International Food & Drug Policy and Law Research Center, Liaoning Shenyang Pharmaceutical University, Liaoning Shenyang 110016, China;

Received:2019-03-12 Revised:2019-03-12 Online:2019-02-25 Published:2019-03-12
Contact: *杨悦,女,博士,教授·博导,药事法规与药品政策。E-mail：yyue@vip.126.com

摘要/Abstract

摘要： 目的为改善我国新药临床试验安全性报告管理提供建议。方法通过查阅FDA及中英文数据库,分析美国新药临床试验安全性报告最终规则制定背景、主要内容、实施绩效及实施壁垒。结果美国在2010年最终规则中详细规定了报告标准、报告时限及报告主体等,以提高报告质量。结论我国现行《药物临床试验质量管理规范》应继续完善修订,并建立上市前与上市后安全性信息的关联。

关键词: 新药, 临床试验, 安全性报告, 最终规则

Abstract: Objective To provide proposals on strengthening and improving the safety reporting of investigational new drug(IND) clinical trials in China. Methods Based on the FDA safety reporting rules, the backgrounds, main contents, implementation effect and barriers of the final rule were thoroughly analyzed. Results The FDA IND safety report final rule clarified the terms definition, specified reporting standards, reporting time limits, and so on, so as to improve the quality of the report. Conclusion We should continue revising Good Clinical Practice(GCP), and establishing the correlation between pre-marketing and post-marketing safety information.

Key words: investigational new drug, clinical trials, safety report, final rule

中图分类号:

刘欢, 张钟艺, 杨悦. 新药临床试验中安全性报告管理[J]. 中国药物警戒, 2019, 16(2): 88-93.

LIU Huan, ZHANG Zhongyi, YANG Yue. Safety Report Management in New Drug Clinical Trials[J]. Chinese Journal of Pharmacovigilance, 2019, 16(2): 88-93.

参考文献

[1] 杨焕. 新药上市前临床试验安全性数据的分析与评价[J]. 中国临床药理学杂志, 2009, 25(5):464-466,470.
[2] 郭韶洁, 赵秀丽, 周辉. 临床试验中不良事件管理的问题及探讨[C]// 中国药理学会药物临床试验专业委员会学术研讨会. 2013.
[3] FDA.About the Center for Drug Evaluation and Research. [EB/OL].(2018-03-19)[2018-07-11].https://www.fda.gov/aboutfda/centers-offices/officeofmedicalproductsandtobacco/cder/ucm184426.htm.
[4] 王涛,王丹,董铎,等.美国药物警戒体系浅析及对我国的启示[J].医药导报,2017,36(4):361-365.
[5] Mckenzie R, Fried M W, Sallie R, et al.Hepatic failure and lactic acidosis due to fialuridine(FIAU), an investigational nucleoside analogue for chronic hepatitis B[J]. New England Journal of Medicine, 1995, 333(17):1099-1105.
[6] 汤仲明, 沈克温. 从新药Fialuridine临床试验发生死亡获得的教训[J]. 国外医学.药学分册, 1994,(4):239-241.
[7] United States Government Publishing Office (GPO). Adverse experience reporting requirements for human drug and licensed biological products; proposed rule[EB/OL].(1994-10-27)[2018-07-12].https://www.govinfo.gov/content/pkg/FR-1994-10-27/html/94-26483.htm.
[8] United States Government Publishing Office(GPO). Expedited safety reporting requirements for human drug and biological products; final rule[EB/OL].(1997-10-07)[2018-07-12].https://www.govinfo.gov/content/pkg/FR-1997-10-07/pdf/97-26255.pdf.
[9] United States Government Publishing Office (GPO). Safety reporting requirements for human drug and biological products; proposed rule[EB/OL].(2003-03-14)[2018-07-12].https://www.govinfo.gov/content/pkg/FR-2003-03-14/pdf/03-5204.pdf.
[10] FDA. Final Rule: Investigational New Drug Safety Reporting Requirements for Human Drug and Biological Products and Safety Reporting Requirements for Bioavailability and Bioequivalence Studies in Humans[EB/OL]. (2010-09-29)[2018-07-11]. https://www.govinfo.gov/content/pkg/FR-2010-09-29/pdf/2010-24296.pdf.
[11] FDA. Safety Reporting Requirements for INDs and BA/BE Studies[EB/OL]. (2012-12)[2018-08-03].https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM227351.pdf.
[12] Kelly W K, Halabi S.Reporing of Adverse Event[M]. America:Springer Publishing Company, 2018,141-149.
[13] Goldman S A .Causality Assessment in Premarketing Drug Clinical Trials: Regulatory Evolution in the USA and Ongoing Concerns:[J]. Drug Safety, 2016, 39(10):895-901.
[14] Jarow J P, Casak S, Chuk M, et al.The Majority of Expedited Investigational New Drug Safety Reports Are Uninformative[J]. Clinical Cancer Research, 2016, 22(9):2111-2113.
[15] Clinical Trials Transformation Initiative. CTTI IND Safety Advancement Project[EB/OL]. (2015-09-20)[2018-08-08].https://www.ctti-clinicaltrials.org/sites/www.ctti-clinicaltrials.org/files/INDsafety-MeetingSummary.pdf
[16] Perez R, Archdeacon P, Roach N, et al.Sponsors' and investigative staffs' perceptions of the current investigational new drug safety reporting process in oncology trials[J]. Clinical Trials, 2017, 14(3):225-233.
[17] 温宝书. 药品审评制度改革工作情况介绍[Z].北京. 2018.
[18] Insight数据库. 现实和解读:CDE 首席科学家何如意[新药临床试验的风险控制异常重要][EB/OL]. (2018-07-10)[2018-08-03].https://mp.weixin.qq.com/s/BPVb1hOhUX2vQAl3yMXTaw.
[19] 徐波,王彦. 药物临床试验期间药物安全监控体系的中外比较分析[J].中国新药杂志,2009,18(14):1291-1293.
[20] CFDA. 关于征求《药物临床试验质量管理规范》修订稿意见的通知[EB/OL].(2015-02-06)[2018-07-12]. http://samr.cfda.gov.cn/WS01/CL0778/113991.html.
[21] CFDA. 总局关于适用国际人用药品注册技术协调会二级指导原则的公告(2018年第10号)[EB/OL].(2018-01-25)[2018-08-08]. http://samr.cfda.gov.cn/WS01/CL0087/223345.html
[22] CDE. 关于发布《药物临床试验期间安全性数据快速报告的快速报告标准程序》的通知[EB/OL]. (2018-04-27)[2018-08-08].http://www.cde.org.cn/news.do?id=314449&method=viewInfoCommon.
[23] CDE. 关于发布《E2B(R2)安全性消息处理和个例安全性报告技术规范》的通知[EB/OL]. (2018-07-30)[2018-08-09].http://www.cde.org.cn/news.do?method=viewInfoCommon&id=314635.
[24] DIA. 从生产企业角度如何改善临床试验中的安全性报告[EB/OL]. (2018-06-07)[2018-07-11].https://mp.weixin.qq.com/s/86XN2FCB28S2OwUlyQi5Pg.
[25] Khozin S, Chuk M, Kim T, et al.Regulatory watch: Evaluating the potential for digital submission of expedited premarket safety reports to the FDA[J]. Nature Reviews Drug Discovery, 2016, 15(10):670.
[26] 药智网. CFDA又出大动作,药审中心新增四大部门并调整两大核心部门职责任务[EB/OL]. (2018-01-04)[2018-08-16].https://news.pharmacodia.com/web/newinfo/information_8a2d983760-a18e480160bb89b7540aba.html.