Review of the Expanded Clinical Trial System in the United States， Japan and Canada and its Enlightenment for China
10.12026/j.issn.1001-8565.2025.01.12
- VernacularTitle: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
- Author:
Meiying MA
1
;
Xiaopei ZHAO
1
;
Lulin LI
2
Author Information
1. College of Medical Humanities， Capital Medical University， Beijing 100069， China
2. People’s Public Security University of China，Beijing 100038， China
- Publication Type:Journal Article
- Keywords:
expanded clinical trials;
accessibility;
drug safety;
drug regulation;
ethical review
- From:
Chinese Medical Ethics
2025;38(1):78-88
- CountryChina
- Language:Chinese
-
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.
