摘要
临床试验信息透明化和以患者为中心一直是欧美监管机构、药企和其他利益攸关方的两大热门话题。根据法规要求,试验主办方需要向非专业人员提供临床试验信息,参试者和一般公众需要能够理解临床试验的标题、知情同意书和试验结果摘要的内容,因此通俗化语言在临床试验文件中的运用日益增多。本文对国际上临床试验中有关通俗化语言的要求和应用以及监管机构的应对进行概要性阐述。
Patient-centricity and clinical trial transparency have been the two hot topics in the regulatory agencies,pharmaceutical industry and other stakeholders.The trial sponsors need to provide clinical trial information to the layperson,while the participants and the general public need to understand the title of clinical trials,informed consent forms and summary of trial results.Therefore,the application of lay language in clinical trial documents is increasing.In this paper,the requirements and application of plain language in clinical trials as well as the corresponding measures taken by the regulatory agencies were summarized.
作者
冯仁田
杨志清
FENG Ren-tian;YANG Zhi-qing(Center of Registration&Regulatory Affairs,Taizhou ZHEJIANG 318000,China;Hlisun Institute,Zhejiang Hisun Pharmaceuical Co.,Lad.Taizhou ZHEJIANG 318000,China;School of Pharmacy,University of Pittsburgh,Piusburgh PENNSYLVANIA 15261,USA)
出处
《中国新药与临床杂志》
CAS
CSCD
北大核心
2021年第5期356-361,共6页
Chinese Journal of New Drugs and Clinical Remedies
基金
国家重大新药创制科技重大专项(2018ZX09303035)。
关键词
临床试验
知情同意
组织和管理
通俗化语言
clinical trial
informed consent
organization and administration
plain language
