基于研究数据表格模型的注释病例报告表在国内临床试验中的应用

Application of annotated case report form based on study data tabulation model in domestic clinical trials

临床数据交换标准协会(Clinical Data Interchange Standards Consortium,CDISC)创建的数据交换标准能极大地提高临床试验的数据质量和审评效率,被大多数国家所认可和推广。美国FDA和日本药品与医疗器械管理局已经明确规定新药临床试验必须符合CDISC标准,我国国家药品监督管理局也鼓励使用该标准,但是目前国内临床试验申办方所递交的原始数据和注释病例报告表(annotated case report form,aCRF)绝大多数都不符合CDISC标准,其结构多变、标准化低,在很大程度上影响着新药的审评时间。本文介绍了基于研究数据表格模型(study data tabulation model,SDTM)的aCRF概念和意义,重点阐述了其制作流程和要求,分析了标准化aCRF在国内临床试验中的应用,旨在为推进我国临床试验数据的标准化工作提供借鉴。

The data interchange standards created by the Clinical Data Interchange Standards Consortium(CDISC),which have been recognized and promoted by most countries,can greatly improve the data quality of clinical trials and the efficiency of reviewers.The US FDA and the Japan Pharmaceuticals and Medical Devices Agency have specified that clinical trials of new drugs must comply with CDISC standards.China National Medical Products Administration also encourages the application of the standards,but most of the raw data and annotated case report form(aCRF)submitted by local clinical trial sponsors do not meet the CDISC standards.They have various forms and non-standard structures,which greatly affect the review period of new drugs.This article introduces the concept and importance of the study data tabulation model(SDTM)aCRF,focuses on its production processes and requirements,and discusses the application of standardized aCRF in clinical trials of China,aiming to promote the standardization of clinical trial data in China.