Survey and analysis of mutual recognition mechanism for ethical review of clinical trials of tumors in China
Oncology clinical trial is an important means for new drug development and treatment evaluation,and ethical review is an important step to protect the rights and safety of subjects.Therefore,establishing a mutual recognition mechanism for the ethical review of clinical trials of tumors has important practical significance,which can improve the approval efficiency,reduce repeated reviews,reduce the ethical risks,and promote international cooperation.This study conducted a comprehensive analysis and summary of the development status of mutual recognition of ethical review of clinical trials of tumors at home and abroad through literature analysis and research.The results showed that the mutual recognition of ethical review of clinical trials of tumors has become an international consensus and has been widely practiced worldwide.However,there are still some problems in the mutual recognition of ethical review of clinical trials of tumors,such as the lack of unified ethical review standards,insufficient training of ethical review personnel,and the lagging construc-tion of an information sharing platform for ethical review.Therefore,the following suggestions are proposed:establish unified ethical re-view standards,standardize ethical review procedures;strengthen the training of ethical review personnel,improve the level of ethical re-view;establish an information sharing platform for ethical review to achieve resource sharing and mutual recognition.
Clinical trials of tumorsEthical reviewMutual recognition
万方数据
维普
