33 - Exploration of the Mutual Recognition Mechanism for Ethical Review in Chinese Oncology Clinical Trials

Background: Oncology clinical trials are critical for the development of new drugs and the assessment of innovative therapies. Ethical review plays a pivotal role in safeguarding participants' rights and ensuring the safety of clinical trials. Establishing a mutual recognition mechanism for the ethical review of oncology trials in China has significant practical implications, including improved review efficiency, reduced redundancy, minimized ethical risks, and enhanced international cooperation.

Methods:  This study employed literature analysis and a nationwide survey to examine the current status of mutual recognition for ethical review in oncology trials. The survey targeted professionals in the field, focusing on the development and application of mutual recognition mechanisms both domestically and internationally.

Conclusion:  The mutual recognition of ethical review in oncology trials has gained international consensus and has been widely implemented worldwide. However, challenges persist, such as the lack of standardized ethical review processes, insufficient training for ethical review personnel, and delayed construction of information-sharing platforms. To address these issues, the study recommends establishing unified ethical review standards, enhancing training, and building a robust information-sharing platform.

Limitations: This research is limited by the regional and institutional disparities in the implementation of ethical review processes across China. Additionally, the scope of data collection may not fully capture the nuances of all clinical trial settings, which could affect the generalizability of the findings.

Discussion:  While mutual recognition of ethical review in oncology clinical trials holds great potential for improving efficiency and consistency, the process is hindered by institutional differences in review standards and capabilities. By implementing clear regulations, improving collaboration between institutions, and fostering a culture of shared responsibility, the quality and speed of ethical reviews can be significantly enhanced, ultimately benefiting patient care and fostering innovation in oncology.