皮肤病药物临床试验的质量控制要点及特征分析  

Key points and characteristics of quality control in clinical trials of dermatological drugs

作　　者：时歆未 崔贞 黄艳平 朱全刚 SHI Xinwei;CUI Zhen;HUANG Yanping;ZHU Quangang(PhaseⅠClinical Trial Center of Shanghai Skin Disease Hospital,Shanghai 200443,China)

机构地区：[1]上海市皮肤病医院Ⅰ期临床试验中心,上海200443

出　　处：《上海医药》2023年第11期59-62,70,共5页Shanghai Medical & Pharmaceutical Journal

基　　金：上海市科学技术委员会课题(20DZ2255200,21S21900900,23S21900800)。

摘　　要：本文以2020年版《药物临床试验质量管理规范》《药物临床试验数据现场核查要点》《药物临床试验机构管理规定》为基础,以试验合规性、数据真实性、操作规范性、记录完整性为核心,归纳皮肤病药物临床试验中知情同意、入排审核、研究病历书写、实验室检查、药物疗效评估、药物和生物样本管理等环节的质量控制要点,着重分析皮肤病药物临床试验的质量控制特点,以期为皮肤病药物临床试验质量控制提供参考,从而为安全、有效的皮肤病药物上市保驾护航。Based on the 2020 edition of“Good Clinical Practice”,“Key Points of On-site Drug Clinical Trial Date Inspection”,and“Regulations on the Management of Drug Clinical Trial Institutions”,with test compliance,data authenticity,operation standardization,and record integrity as the core,the key points of quality control in clinical trials of dermatological drugs such as informed consent,inclusion review,research medical record writing,laboratory examination,drug efficacy evaluation,drug and biological sample management were summarized and the quality control characteristics of clinical trials of dermatological drugs were focused on,so as to provide reference for the quality control of clinical trials of dermatological drugs and escort for their safe and effective marketing.

关 键 词：皮肤病 药物临床试验 质量控制 

分 类 号：R-3[医药卫生] R951