医药创新战略下临床试验的伦理审查前置模式分析与讨论

Analysis and Discussion on the Ethical Pre-review Model of Clinical Trials under the Pharmaceutical Innovation Strategy

国家生物医药创新战略的实施,对临床试验的伦理审查提出了新要求,伦理审查前置受到更多关注。根据中国新药临床试验和伦理审查的现状,讨论了伦理审查前置的概念、优势与必要性,梳理了现阶段实施伦理审查前置存在的问题与挑战,并对医药创新战略下临床试验如何更好实施伦理审查前置提出了如下建议:应当明确伦理审查“前置”的完整定义;伦理审查应基于必要的参考依据而开展;应当明确伦理审查前置的适用范围;伦理审查前置以后,批件的表述应当规范准确。

With the implementation of the national biomedical innovation strategy,new requirements for ethical review of clinical trials have been put forward,and more attention has been paid to the ethical pre-review.Based on the current situation of clinical trials and ethical review of new drugs in China,this paper discussed the concept,advantages and necessity of ethical pre-review,sorted out the problems and challenges in the implementation of ethical pre-review at this stage,and put forward the following suggestions on how to better implement ethical pre-review in clinical trials under the pharmaceutical innovation strategy:the complete definition of ethical pre-review should be made clearly;ethical review should be carried out on the basis of necessary reference;the scope of application of ethical pre-review should be clarified;after the ethical pre-review,the statement of the approval document should be standardized and accurate.