新药临床试验申请评价基本考虑

Main consiration of investigational new drug clinical evaluaion

临床试验是创新药物研发的核心,因为药物的有效性和安全性最终都是依靠药物临床试验来进行检验的。本文从新药临床试验的评价模式、新药临床申请评价的内容、新药临床试验评价中的考虑要点和决策四个方面论述了当前国家食品药品监督管理总局药品审评中心对于新药临床试验申请的思考方向。

Clinical trials are the core of new drug, because efficacy and safety of new drug depends on clinical trials finally.This paper include four contents： evaluation mode of investigational new drug （ IND ） , contents of IND, main points of IND and strategic decision.This paper discusses the current direction of thinking on China Food and Drug Administration Center for Drug Evaluation application for clinical trial.