抗肿瘤药物临床试验受试者出组后延伸给药申请程序

杨凤; 衡建福; 刘伊; 唐琪; 李坤艳

doi:10.11817/j.issn.1672-7347.2023.210739

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抗肿瘤药物临床试验受试者出组后延伸给药申请程序
Procedures for application of the extended dosing after antitumor drug clinical trials
中南大学学报(医学版) 中南大学学报(医学版) 2023年48卷第4期页码：508-515
作者机构：

湖南省肿瘤医院国家药物临床试验机构办公室，长沙 410013
作者简介：

杨凤，Email: yangfeng0711@126.com, ORCID: 0009-0007-8621-6556
李坤艳，Email: likunyan@hnca.org.cn, ORCID: 0009-0001-6805-9768
基金信息：

湖南省自然科学基金(2020JJ9043);湖南省卫生健康委科研课题(202213054878)
DOI：10.11817/j.issn.1672-7347.2023.210739
中图分类号：
CSTR：
纸质出版日期： 2023-04-28 ，

收稿日期： 2021-12-06 ，

杨凤, 衡建福, 刘伊, 唐琪, 李坤艳. 抗肿瘤药物临床试验受试者出组后延伸给药申请程序[J]. 中南大学学报(医学版), 2023, 48(4): 508-515.

YANG Feng, HENG Jianfu, LIU Yi, TANG Qi, LI Kunyan. Procedures for application of the extended dosing after antitumor drug clinical trials[J]. Journal of Central South University. Medical Science, 2023, 48(4): 508-515.
杨凤, 衡建福, 刘伊, 唐琪, 李坤艳. 抗肿瘤药物临床试验受试者出组后延伸给药申请程序[J]. 中南大学学报(医学版), 2023, 48(4): 508-515. DOI：10.11817/j.issn.1672-7347.2023. 210739

YANG Feng, HENG Jianfu, LIU Yi, TANG Qi, LI Kunyan. Procedures for application of the extended dosing after antitumor drug clinical trials[J]. Journal of Central South University. Medical Science, 2023, 48(4): 508-515. DOI：10.11817/j.issn.1672-7347.2023.210739

摘要

新药临床试验已被癌症患者和医生公认为治疗癌症的积极方式，而延伸给药则是从临床试验退出后患者继续获得试验药物的一种特殊途径，国外已确立相关法规，但国内关于延伸给药管理办法未正式颁布，也无细则性文件指导延伸给药。目前各医疗机构临床试验用药物的延伸给药还处于摸索阶段，尚未建立一套健全且满足患者紧急用药需求的管理体系。本文结合湖南省肿瘤医院延伸给药实践经验，初步探索抗肿瘤药物临床试验受试者延伸给药的申请程序与伦理审查相关要求。在申请程序上建议明确各方职责，建立患者-医疗机构-申办者共同申请制度；伦理审查过程中建议在各方充分考量患者延伸给药的风险与获益后，再由伦理委员会综合评估决定是否批准延伸给药。

Abstract

New drug clinical trials have been considered as a positive way for treating cancer by cancer patients and doctors

and the extended dosing is a special way for patients’ withdrawal from antitumor clinical trials to obtain investigational new drugs. However

neither the regulations of expanded dosing nor the detail documents for expanded dosing have been officially published in China. At present

expanded dosing of investigational drugs is still at the exploratory stage in various medical institutions

and a complete management system has not been established to meet patients’ urgent needs for drug use. Based on the practical experience of extended dosing in Hunan Cancer Hospital

this paper preliminarily explored the application procedures and ethical review requirements of extended dosing for subjects in antitumor clinical trials. It is necessary to clarify the responsibilities of all patients in the procedure and establish a patient-medical institution-sponsor joint application system. In the process of ethical review

it is recommended that all parties fully consider the risks and benefits of extended dosing for patients

and then the ethics committee makes a comprehensive assessment to decide whether to approve extended dosing.

关键词

抗肿瘤药物临床试验延伸给药试验新药伦理审查

Keywords

antitumor drug clinical trialextended dosinginvestigational drugsethical review

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