35 - Survey and Analysis of the Mutual Recognition for Ethical Review in Oncology Clinical Trials in China

Background:  This study investigates the mechanism of mutual recognition for ethical review in oncology clinical trials in China. With the rapid development of biomedicine, particularly in oncology drug research, ethical review faces increasing complexity and demands for efficiency. To address this, the Medical Ethics Society of China Anti-Cancer Association initiated a nationwide survey to explore the need for a mutual recognition among ethical review committees in oncology. This study aims to analyze the current state, challenges, and opportunities for establishing a mechanism.

Methods:  A questionnaire-based survey was conducted between July 14-17, 2023, targeting ethical review professionals across 24 provinces and 37 cities in China. A total of 203 valid responses were collected, representing a broad spectrum of participants, including both members and non-members of the Medical Ethics Society. The questionnaire focused on key aspects of mutual recognition, including the necessity, basic conditions for member institutions, applicable project types, and the need for an information-sharing platform. Descriptive statistical methods were used to analyze the data.

Conclusion:  The results demonstrate a strong demand for establishing a mutual recognition mechanism in the oncology sector. Over 94% of respondents expressed the necessity for a information system, citing improved efficiency, consistency, and resource savings. However, challenges remain, including the need to standardize review processes and ensure high-quality, consistent ethical oversight. The study concludes that a structured and well-regulated mutual recognition system could significantly improve the efficiency of ethical reviews in oncology clinical trials in China.

Limitations: The study is limited by the scope of its sample, which, while geographically broad, may not fully capture all regional or institutional variations in ethical review practices. Additionally, the reliance on self-reported data from survey respondents may introduce bias.

Discussion:  The survey results highlight the pressing need for mutual recognition in oncology clinical trials, driven by the complexity of trial protocols and the need for efficient ethical reviews. The study suggests that while most institutions are willing to join a mutual recognition alliance, success will depend on developing clear standards, ensuring consistent review quality, and establishing robust information-sharing platforms. Future efforts should focus on enhancing training, quality control, and inter-institutional collaboration to ensure the system's effectiveness and sustainability.