我国新药临床试验的风险管理模式探讨

中国药物警戒 ›› 2014, Vol. 11 ›› Issue (8): 488-491.

我国新药临床试验的风险管理模式探讨

薛薇, 董凡, 李可欣^*

北京医院药学部药物临床风险与个体化应用评价北京市重点实验室,北京 100730

收稿日期:2016-02-03 修回日期:2016-02-03 出版日期:2014-08-08 发布日期:2016-03-02
通讯作者: 李可欣,女,主任药师,药品I期临床研究与管理。E-mail：kexinli6202@163.com
作者简介:薛薇,女,主管药师,药品I期临床研究。
基金资助:
基金项目：国家科技部十二五重大新药创制-心脑血管疾病新药临床评价技术平台研究课题（2012ZX09303-008-002）

Preliminary Study of Risk Management Mode of New Drug Clinical Trials in China

XUE Wei ,DONG Fan ,LI Ke-Xin^*

Beijing Key Laboratory of Drug Clinical Risk and Personalized Medication Evaluation, Department of Pharmacy, Beijing Hospital, Beijing 100730, China

Received:2016-02-03 Revised:2016-02-03 Online:2014-08-08 Published:2016-03-02

摘要/Abstract

摘要： 目的从临床试验研究者的角度探索新药临床试验的风险管理模式,为其在我国的建立与实施提供参考。方法分析风险管理的通用模式与架构,借鉴发达国家成熟药品风险管理体系的法规与原则,阐述我国新药临床试验风险管理的发展现状,开拓创新适合我国国情的风险管理模式。结果与结论基于一般风险管理及药品风险管理的理论与实践,提出适合我国新药临床试验的风险管理新模式的构想。

关键词: 新药临床试验, 风险管理, 风险管理模式

Abstract: Objective To provide references for establishment and implementation of risk management in new drug clinical trials, from the perspectives of investigators. Methods General modes and constructions of risk management were analyzed, and regulations and principles for drug risk management in developed country were used for comprehensive references. Moreover, the present situation of drug risk management in clinical trial in China was discussed. Results and Conclusion Based on the preliminary exploration, we proposed the new risk management mode for clinical trials of new drugs suitable for China.

Key words: new drug clinical trials, risk management, risk management mode

中图分类号:

薛薇, 董凡, 李可欣. 我国新药临床试验的风险管理模式探讨[J]. 中国药物警戒, 2014, 11(8): 488-491.

XUE Wei ,DONG Fan ,LI Ke-Xin. Preliminary Study of Risk Management Mode of New Drug Clinical Trials in China[J]. Chinese Journal of Pharmacovigilance, 2014, 11(8): 488-491.

导出引用管理器 EndNote|Ris|BibTeX

链接本文: https://zgywjj.magtechjournal.com/CN/

https://zgywjj.magtechjournal.com/CN/Y2014/V11/I8/488

参考文献

[1] 陈玉和,姜秀娟.风险评价[M]. 北京：中国标准出版社, 2009: 1-6.
[2] 杨勇. 对风险管理若干原则的探讨[J]. 安全, 2011, 32(7): 35-37.
[3] AIRMIC, ALARM, IRM. A Risk Management Standard[EB/OL]. [2014-04-09]. http://www.theirm.org/knowledge-and-resources/risk-management-standards/irms-risk-management-standard/.
[4] ISO. ISO 31000:2009, Risk management-Principles and guidelines on implementation[S/OL].(2009-11-15) [2013-12-20].https://www.iso.org/obp/ui/#iso:std:iso：31000:ed-1:v1:en.
[5] 李幼平, 李媛媛, 王莉. 从那他珠单抗不良反应处理看生物制剂风险监测[J]. 中国循证医学杂志, 2010, 10(7): 811-816.
[6] 李春潇, 李可欣, 武志昂. 美国风险物质数据库构建经验及启示[J]. 中国药物警戒杂志, 2012, 9(7): 410-413.
[7] EMEA/CHMP. Guideline on risk management systems for medicinal products for human use[EB/OL]. (2005-11-20) [2013-12-20]. http://drug.fda.moph.go.th/zone_admin/files/EPO_S_3_22chmp_riskmanage_medprd9626805_2005.pdf.
[8] ICH.Guidance for Industry: E2E Pharmacovigilance Planning[EB/OL].(2005-04-01)[2013-12-20].http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm073107.pdf.
[9] FDA. Guidance for Industry: Premarketing Risk Assessment[EB/OL]. (2005-03-05) [2013-12-20].http://www.fda.gov/downloads/RegulatoryInformation/Guidances/ucm126958.pdf.
[10] Suntharalingam G, Perry M R,Ward S, et al. Cytokine storm in a phase 1 trial of the anti-CD28 monoclonal antibody TGN1412 [J]. N. Engl. J. Med., 2006,355(10): 1018-1028.
[11] EMEA. Guideline on strategies to identify and mitigate risks for first-in-human clinical trials with investigational medicinal products[EB/OL]. (2007-07-19) [2014-04-08]. https://firstclinical.com/regdocs/doc/?db=INT_EMEA_First.
[12] FDA. Guidance for Industry: Estimating the Maximum Safe Starting Dose in Initial Clinical Trials for Therapeutics in Adult Healthy Volunteers[EB/OL]. (2005-07-05) [2013-12-20].http://www.fda.gov/downloads/Drugs/Guidances/UCM078932.pdf.
[13] FDA. Guidance for Industry: Safety Testing of Drug Metabolites[EB/OL]. (2008-02-15) [2013-12-20].http://www.fda.gov/downloads/Drugs/GuidelineComplianceRegulatoryInformation/Guidelines/ucm079266.pdf.
[14] FDA. Reviewer Guidance: Evaluating the Risks of Drug Exposure in Human Pregnancies[EB/OL]. (2005-04-28) [2013-12-20].http://www.fda.gov/downloads/scienceresearch/specialtopics/womenshealthresearch/ucm133359.pdf.
[15] ICH. Guidance for Industry: E14 clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for nonantiar-rhythmic drugs[EB/OL]. (2005-10-20) [2013-12-20].http://www.fda.gov/RegulatoryInformation/Guidances/ucm129335.htm.
[16] 国家食品药品监督管理局药品评价中心暨药品不良反应监测中心. 关于印发“高风险品种'风险管理计划'推进行动”的通知[EB/OL] (2008-06-27) [2014-06-12]. http://www.doc88.com/p-493909800324.html.
[17] 国家食品药品监管局药品审评中心.中药注射剂风险管理计划指导原则（试行）[EB/OL].(2010-10-22) [2014-06-12].http://www.cde.org.cn/news.do?method=largeInfo&id=311904.
[18] 国家食品药品监管局药品审评中心. 健康成年志愿者首次临床试验药物最大推荐起始剂量的估算指导原则[EB/OL].(2012-05-15) [2014-06-12]. http://www.cde.org.cn/zdyz.do?method=largePage&id=133.
[19] 国家食品药品监管局药品审评中心. 2012年度中国药品审评报告[R/OL]. (2013-02-28) [2013-12-20]. http://www.cde.org.cn/news.do?method=largeInfo&id=312956.