Changhui Liu, Jiyin Zhou

Jiyin Zhou

October 30, 2026

Clinical research initiated by researchers, Unlisted products, Management mode, Ethical review.

Objective: The objective of this paper is to further improve the management level and research quality of clinical research initiated by researchers in China. Methods: The research is conducted by analyzing the current situation of unlisted products used in clinical research initiated by researchers in China and its regulations, and drawing on the regulatory experience and management mode of unlisted products used in clinical research initiated by foreign researchers. Results: Although there are differences in the management regulations and management modes of IIT in different countries, most of them classify the risk of participants according to the research, carry out risk stratification management, and take into account science and ethics. Conclusion: On the basis of drawing lessons from relevant foreign management experience and models, it is necessary for China to continuously improve policies and regulations, strengthen process management, and establish and improve relevant systems. It is also necessary to promote mutual recognition of ethical review, promoted resource integration, establish a management system in line with the actual situation of China at this stage, and further promote the standardization and high-quality development of IIT in China.

© 2026, the Authors. Published by ISCCAC

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