医药导报2026，Vol.45Issue(4)：735-740,6.DOI:10.3870/j.issn.1004-0781.2026.04.026
医疗卫生机构抗肿瘤新药临床试验立项审查中的分析与思考——基于合规性评估视角
Analysis and Reflection on the Project Approval Review of Clinical Trials of New Anti-tumor Drugs in Medical and Health Institutions:Based on the Perspective of Compliance Assessment
摘要
Abstract
Objective Under the new circumstances of medical technology innovation,and based on the reform of the review and approval system for clinical trials,this study aims to analyze and discuss the key points of project approval review for innovative anti-tumor drug clinical trials from the perspective of the drug clinical trial institution(hereinafter referred to as"insti-tution").The goal is to proactively address potential management risks arising from accelerated innovation.Methods Through literature review,policy interpretation and work experience,we examined the regulatory requirements for the traditional project approval review responsibilities of institutions.We further analyzed the compliance challenges arising from the new reforms in the key aspects of institutional project review under the priority evaluation and approval system.Results Currently,the National Medical Products Administration(NMPA)adopts flexible and diverse approaches in approving registration clinical trials for inno-vative drugs.Institutions should focus on the five key attributes of the core"approval documents":specificity,phase-based na-ture,comprehensive validity,rationality,and necessity.Additionally,institutions must accurately identify risk points and formu-late tailored review strategies.Conclusions Under the flexible and diverse access way implemented by NMPA,institutions should actively explore the establishment of an efficient and universally applicable review mechanism.This mechanism should en-compass considerations of multiple attributes of"approval documents",such as specificity,phase-based nature,and comprehen-sive validity,as well as evaluations of the rationality and necessity of clinical trials.Thus,institutions can ensure the high-quality development and high-level safety of clinical trials across multiple dimensions.关键词
医学科技创新/临床试验/立项审查/合规性Key words
Medical technology innovation/Clinical trial/Project approval review/Compliance分类
医药卫生引用本文复制引用
冯钰,储天晴,颜波,陈仲林..医疗卫生机构抗肿瘤新药临床试验立项审查中的分析与思考——基于合规性评估视角[J].医药导报,2026,45(4):735-740,6.基金项目
2023年上海申康医院发展中心《促进市级医院临床技能与临床创新三年行动计划》研究型医师创新转化能力培训项目(SHDC2023CRS046). （SHDC2023CRS046）
