药物临床试验研究者手册撰写现况调研与分析  

Investigation and analysis of the current situation of the writing of investigator’s brochures for drug clinical trials

作　　者：曹烨[1] 卓俊城 姜文月 陈文娜 CAO Ye;ZHUO Jun-cheng;JIANG Wen-yue;CHEN Wen-na(Clinical Research Department/Drug Clinical Trial Institution of Cancer Prevention and Treatment Center of Sun Yat-sen University,Guangzhou 510060,China;Guangzhou Jeeyor Pharmaceutical Research Co.,Ltd.,Guangzhou 510405,China;Qingyuan People’s Hospital(The Sixth Affiliated Hospital of Guangzhou Medical University),Qingyuan 511518,China)

机构地区：[1]中山大学肿瘤防治中心临床研究部/药物临床试验机构,广州510060 [2]广州静远医药研究有限公司,广州5100405 [3]清远市人民医院(广州医科大学附属第六医院),清远511518

出　　处：《中国新药杂志》2022年第6期579-585,共7页Chinese Journal of New Drugs

摘　　要：目的:分析国内药物临床试验研究者手册(investigator's brochure,IB)撰写内容结构对现有法规政策和指南的依从性。方法:收集国内某肿瘤医院自2017—2020年的IB,38家申办者递交的IB共67份;国内企业26家,IB 44份;国外企业12家,IB 23份。结果:根据法规和指南的撰写要求,结果显示49%的IB目录结构存在缺失。缺失的章节主要是“评估严重不良反应预期性的安全性参考信息”、“数据概要和研究者指南”和“在人体中作用”。规范性方面,主要在“数据概要和研究者指南”和“评估严重不良反应预期性的安全性参考信息”章节存在明显的不规范。结论:国内大部分IB尚未遵从新版《药品临床试验管理规范》(GCP)与国家药品监督管理局药品审评中心《研究者手册中安全性参考信息撰写技术指导原则》的要求撰写,因此有必要提高其依从性和规范性,确保临床试验相关方对安全信息理解的一致性和准确性。Objective:To analyze the compliance of the content and structure of the domestic investigator’s brochures(IBs)for drug clinical trials with the existing laws,policies and guidelines.Methods:The IBs of one cancer hospital in China from 2017 to 2020 were collected and analyzed.A total of 67 IBs were submitted by 38 sponsors;among which 44 by 26 domestic enterprises;23 by 12 foreign enterprises.Results:According to the requirements of regulations and guidelines,it was found that 49%of IBs lacked some directory structures.The missing chapters were mainly“safety reference information for evaluating the expectation of serious adverse reactions”,“data summary and investigator’s Guide”and“role in human body”.In terms of standardization,there were obvious irregularities in the chapters of“data summary and investigator’s Guide”and“safety reference information for evaluating the expectation of serious adverse reactions”.Conclusion:Most IBs in China did not comply with the requirements of the new GCP and CDE-RSI.Therefore,it is necessary to improve their compliance and standardization and ensure the consistency and accuracy of the understanding of safety information by relevant parties of clinical trials.

关 键 词：研究者手册 安全性参考信息 可疑且非预期严重不良反应 规范化 申办者 

分 类 号：R95[医药卫生—药学]