药物临床试验期间安全监测计划技术要点

doi:10.19803/j.1672-8629.20250270

中国药物警戒 ›› 2025, Vol. 22 ›› Issue (9): 1003-1007.
DOI: 10.19803/j.1672-8629.20250270

药物临床试验期间安全监测计划技术要点

苏娴, 刘文东, 胡洋平, 王晓晗, 王海学^*

国家药品监督管理局药品审评中心,北京 100076

收稿日期:2025-05-06 发布日期:2025-09-22
通讯作者: ^*王海学,男,博士,主任药师,临床试验管理。E-mail: wanghx@cde.org.cn
作者简介:苏娴,女,博士,副主任药师,新药临床试验。
基金资助:
国家科技重大专项重大新药创制（2015ZX09501008）

Technical Highlights of Safety Monitoring Plans during Drug Clinical Trials

SU Xian, LIU Wendong, HU Yangping, WANG Xiaohan, WANG Haixue^*

Center for Drug Evaluation, National Medical Products Administration, Beijing 100076, China

Received:2025-05-06 Published:2025-09-22

摘要/Abstract

摘要： 目的分析临床试验安全监测计划的技术要点,针对其实施阶段关键挑战提出应对建议。方法系统梳理国内外安全监测框架的发展历程,对比分析不同框架的异同点,识别实施中的共性问题与挑战,并基于此提出安全监测计划构建与执行的关键技术要素。结果提出涵盖风险识别、信号监测和评估及风险最小化措施等维度的安全监测计划的核心要素框架;揭示在计划动态更新、跨学科合作等方面的实施挑战。结论为有效保障受试者安全,申请人应根据研发进展和新获得的安全性与有效性信息,持续、及时更新安全监测计划;始终确保执行适当的药物警戒活动与风险最小化措施,并主动与监管部门及其他相关方保持良好沟通。

关键词: 临床试验, 安全监测计划, 药物警戒, 临床试验申请, 创新药

Abstract: Objective To define the highlights of safety surveillance plans (SSP) and address key challenges to implementation of these plans. Methods The global SSP frameworks were traced, compared and contrasted. The shared issues and challenges facing implementation were identified before essential technical elements of these plans were summarized. Results A framework composed of key elements of SSP was recommended that involved such dimensions as risk identification, signal monitoring/assessment, and measures for risk minimization. Critical challenges were unveiled that included dynamic updating of plans and cross-disciplinary collaboration. Conclusion Applicants are to keep updating SSP based on advances in R&D and on the latest information about safety and validity, stick to pharmacovigilance, work towards minimization of risks and be active in communicating with regulators or agencies concerned in order to ensure the safety of subjects.

Key words: Clinical Trial, Safety Surveillance Plans (SSP), Pharmacovigilance, Investigational New Drug (IND), Innovative Drug

中图分类号:

R951
R994.11

苏娴, 刘文东, 胡洋平, 王晓晗, 王海学. 药物临床试验期间安全监测计划技术要点[J]. 中国药物警戒, 2025, 22(9): 1003-1007.

SU Xian, LIU Wendong, HU Yangping, WANG Xiaohan, WANG Haixue. Technical Highlights of Safety Monitoring Plans during Drug Clinical Trials[J]. Chinese Journal of Pharmacovigilance, 2025, 22(9): 1003-1007.

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参考文献

[1] FDA. Draft Guidance for Industry: Sponsor Responsibilities- Safety Reporting Requirements and Safety Assessment for IND and Bioavailability/Bioequivalence Studies. FDA-2020-D-2099.2021[EB/OL]. [2025-06-18]. https://www.fda.gov/media/150356/download.
[2] CIOMS. Management of Safety Information from Clinical Trials-Report of CIOMS Working Group VI[M]. Geneva, Switzerland: CIOMS, 2005.
[3] General Office of the State Council. General Office of the State Council's Opinions on Comprehensively Deepening the Reform of Drug and Medical Device Supervision and Promoting the High-quality Development of the Pharmaceutical Industry(国务院办公厅关于全面深化药品医疗器械监管改革促进医药产业高质量发展的意见) [EB/OL]. (2025-01-03)[2025-03-30]. https://www.gov.cn/zhengce/zhengceku/202501/content_6996117.htm.
[4] NMPA. National Medical Products Administration's Notice on Printing and Distributing the Pilot Work Plan for Optimizing the Review and Approval of Clinical Trials of Innovative Drugs(国家药监局关于印发优化创新药临床试验审评审批试点工作方案的通知) [EB/OL]. (2024-07-31)[2025-04-15]. https://www.gov.cn/zhengce/zhengceku/202408/content_6965736.htm.
[5] CIOMS. Practical Aspects of Signal Detection in Pharmacovigilance. Report of CIOMS Working Group VIII[M]. Geneva, Switzerland: CIOMS, 2010.
[6] CROWE BJ, XIA HA, BERLIN JA, et al.Recommendations for Safety Planning, Data Collection, Evaluation, and Reporting During Drug, Biologic and Vaccine Development: a Report of the Safety Planning, Evaluation, and Reporting Team[J]. Clin Trials, 2009, 6: 430-440.
[7] BALL G, KUREK R, HENDRICKSON BA, et al.Global Regulatory Landscape for Aggregate Safety Assessments: Recent Developments and Future Directions[J]. Ther Innov Regul Sci, 2020, 54(2): 447-461.
[8] ICH. E6(R2) Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice, Current Step 4 Version.2016[EB/OL]. (2016-11-09)[2025-04-15]. https://database.ich.org/sites/default/files/E6_R2_Addendum.pdf.
[9] CDE, NMPA. Notice on Publicly Soliciting Opinions on the Chinese Translation of the Principles and Annex 1 of ICH“E6 (R3): Technical Guidance on Good Clinical Practice (GCP)”(关于公开征求 ICH《E6 (R3): 药物临床试验质量管理规范技术指导原则 (GCP)》原则及附件1中文翻译稿意见的通知)[EB/OL]. (2025-03-20)[2025-04-15]. https://www.cde.org.cn/ichWeb/news/getNewsDetail/2/550f26aae6aeef12edaa81f13f1ce609/3.
[10] FDA. Code of Federal Regulations Title 21 Part 312 - Investigational New Drug Application[EB/OL]. (2025-06-13)[2025-06-18]. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-D/part-312.
[11] XIA HA, JIANG Q.Statistical Evaluation of Drug Safety Data[J]. Ther Innov Regul Sci, 2014, 48(1): 109-120.
[12] FDA. E9(R1) Statistical Principles for Clinical Trials: Addendum: Estimands and Sensitivity Analysis in Clinical Trials[EB/OL]. (2021-05-11) [2025-06-18]. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/e9r1-statistical-principles-clinical-trials-addendum-estimands-and-sensitivity-analysis-clinical.
[13] SAMARA C, GARCIA A, HENRY C, et al.Safety Surveillance during Drug Development: Comparative Evaluation of Existing Regulations[J]. Adv Ther, 2023, 40(6): 2147-2185.

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药物临床试验期间安全监测计划技术要点

Technical Highlights of Safety Monitoring Plans during Drug Clinical Trials

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