[Conflict of interest and management guidelines in human use experience study of TCM]

In the human use experience study of TCM, researchers may intentionally or unintentionally ignore the interests of patients due to their own interests or the interests of medical institutions. Conflict of interest is a common existing situation in the human use experience study, and early and thorough identification and management of conflicts of interest are necessary to ensure studies' neutrality. This paper systematically discussed the basic concept of conflicts of interest and introduced the classification of clinical studies and management regulations for conflicts of interest in China and abroad. By elaborating on the connotation of human use experience and interpreting related laws, regulations, and guiding principles, it was proposed that the first phase of the human use experience study should be managed with reference to IIT of TCM, and the second phase should be implemented in accordance with GCP requirements. Based on a comprehensive analysis of the attributes of the human use experience study and the characteristics of conflicts of interest, the Professional Committee of Clinical Evaluation of TCM of the Chinese Pharmaceutical Association has formulated the management guidelines for conflicts of interest, covering nine aspects: scope of application, stakeholders, disclosure of conflicts of interest, research proposal review, ethics committee review, research quality management, supervision for conflicts of interest, translation of research achievements, and management for conflicts of interest, thereby ensuring the standardized conduct of the human use experience study.