我国中药新药临床试验申请批准情况的影响因素分析——基于Logistic回归模型的实证分析

中药新药研发是中医药实现振兴发展的必由之路。近年来，国家出台了系列政策改革新药审评审批制度，以鼓励新药研发创新，但中药新药研发的发展状况不佳，2015年以来的各类申报及获批数量均处于历史最低水平，严重阻碍了新形势下中医药的发展。基于2008—2019年我国中药新药临床试验申报数据，通过运用二分类Logistic回归模型，实证分析批准情况的影响因素并探讨可能的原因，为推动我国中药新药研发提供相应的建议。

Factors Affecting Approval of New Chinese Medicine Clinical Trials in China: Empirical Analysis Based on Logistic Regression Model

The research and development of new Chinese medicines is a vital way to realize the revitalization and development of traditional Chinese medicine (TCM). In recent years, a series of policies have been issued in China to reform the new drug review and approval system to encourage the development and innovation of new drugs. However, the development of new Chinese medicines is still constrained. Since 2015, the number of applications and approvals has been at the lowest level in history, which has seriously hindered the development of TCM under new conditions. Based on the application data of clinical trials of new Chinese medicines in China from 2008 to 2019, the present study employed a binary Logistic regression model for the empirical analysis of factors affecting approval and the exploration of possible reasons to provide corresponding suggestions for promoting the research and development of new Chinese medicines in China.