美国、日本和加拿大拓展性临床试验制度评介及对中国的启示
Review of the Expanded Clinical Trial System in the United States,Japan and Canada and its Enlightenment for China
马美英 1赵晓佩 1李璐林2
作者信息
- 1. 首都医科大学医学人文学院,北京 100069
- 2. 中国人民公安大学法学院,北京 100038
- 折叠
摘要
拓展性临床试验制度旨在为患有严重或危及生命且尚无有效治疗手段的疾病的患者提供临床试验药物,其实质是寻求患者用药的可及性与药品行业发展的稳健性,以及拓展使用临床试验药物的风险与保障患者生命健康权益的需求之间的平衡.《中华人民共和国药品管理法》第二十三条对这一制度的适用标准和操作程序作了原则性的说明,没有实施细则,该制度在实践中难以有效运转.美国、日本和加拿大通过法律、规章以及指南对该制度的适用条件、申请主体、审查主体和内容以及保障措施做了较为翔实的规定.立足于中国立法环境与监管实际,考虑到该制度在中国尚处于起步阶段,建议适当参考国外有益经验,尽快颁布规章和规范性文件,明确拓展性临床试验的类型、申请人、审查主体等内容,厘定各方主体的责任,推动中国拓展性临床试验制度的规范化,促进患者的用药可及性,切实保障患者的生命健康权益与药品行业发展的稳健性和安全性.
Abstract
The expanded clinical trial system is designed to provide clinical trial drugs for patients suffering from serious or life-threatening diseases for which there is no effective treatment,essentially seeking a balance between the accessibility of drugs to patients and the soundness of the development of the pharmaceutical industry,as well as between the risk of expanding the use of clinical trial drugs and the need to safeguard the rights and interests of patients'lives and health.Article 23 of China's Drug Administration Law provides only a principled description of the applicable standards and operating procedures for this system,with no implementing regulations,making it difficult for the system to function effectively in practice.The United States,Japan,and Canada have made detailed provisions on the conditions of application,applicants,review subjects and contents,and safeguards of the system through laws,regulations,and guidelines.Based on China's legislative environment and regulatory reality,and considering that the system is still in the initial stage in China,it is recommended that appropriate reference be made to the beneficial experience of foreign countries and that regulations and normative documents be promulgated as soon as possible to clarify the types of expanded clinical trials,applicants,review subjects etc.,and to determine the responsibilities of all the parties involved,to promote the standardization of China's expanded clinical trial system,to promote the availability of medicines to patients,and to effectively safeguard the rights and interests of patients'lives and health,and the soundness and safety of the development of the pharmaceutical industry.
关键词
拓展性临床试验/可及性/药品安全/药品监管/伦理审查Key words
expanded clinical trials/accessibility/drug safety/drug regulation/ethical review引用本文复制引用
出版年
2025
国家科技期刊平台
NSTL
万方数据