中国医学伦理学2025，Vol.38Issue(1)：78-88,11.DOI:10.12026/j.issn.1001-8565.2025.01.12
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
摘要
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分类
医药卫生引用本文复制引用
马美英,赵晓佩,李璐林..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[J].中国医学伦理学,2025,38(1):78-88,11.基金项目
国家社科基金项目"'互联网'时代数字药的应用与规制研究"(24BFX033) （24BFX033）
