关于多中心临床试验伦理协作审查的思考

Consideration of ethical collaborative review of multi-center clinical trials

多中心合作开展药物临床试验已成为常态,多中心研究机构伦理委员会各自审查给研究的实施造成了负担,可能导致项目启动延迟。中共中央办公厅和国务院办公厅印发的《关于深化审评审批制度改革鼓励药品医疗器械创新的意见》明确指出要完善伦理委员会机制、提高伦理审查效率。针对如何提高多中心伦理审查效率避免重复审查,本文结合中国临床研究能力提升与受试者保护高峰论坛(CCHRPP)的《临床研究伦理协作审查共识(试行版)》,梳理了我国多中心研究伦理协作审查落地需要解决的几个问题。

Multi-center cooperation in drug clinical trials has become the normal,and the multi-center research institution ethics committees review respectively has caused a burden on the implementation of the study and delayed project initiation. Opinions on Deepening the Reform of Review,Examination and Approval System,and Encouraging the Innovation of Drugs and Medical Devices of the General Office of the CPC Central Committee and the General Office of the State Council clearly points out that it is necessary to improve the ethics committee mechanism and improve the efficiency of ethical review. How to improve the efficiency of multi-centered ethics review to avoid double reviews？ This article sorts out several issues that need to be addressed in the multi-center research ethics collaborative review in China combined with CCHRPP ＇s Clinical Research Ethical Collaborative Review Consensus（ Trial version）.