基于CDASH标准的肿瘤临床试验病例报告表设计  

Design of case report form for oncology clinical trials based on CDASH

作　　者：陈建芳 娄冬华[1] CHEN Jianfang;LOU Donghua(School of Public Health,Nanjing Medical University,Nanjing 211166,Jiangsu,China)

机构地区：[1]南京医科大学公共卫生学院,江苏南京211166

出　　处：《中国临床药理学与治疗学》2022年第7期762-767,共6页Chinese Journal of Clinical Pharmacology and Therapeutics

基　　金：国家自然科学基金(81773554)。

摘　　要：目的:探讨基于临床数据获取协调标准(clinical data acquisition standards harmonization,CDASH)的肿瘤临床试验病例报告表(case report form,CRF)的设计意义、方法及内容。方法:对照CDASH v 2.2,分析肿瘤临床试验数据特点,设计符合肿瘤临床试验实际需求的标准化CRF。结果:将CDASH标准应用到肿瘤临床试验CRF的设计中,规范肿瘤临床试验数据采集,以使肿瘤临床试验CRF设计相对标准化,提升数据质量。结论:执行基于CDASH标准的肿瘤CRF设计,能够促进肿瘤临床研究数据交换、共享,有利于提升肿瘤临床研究结果可靠性。AIM:To investigate the design significance,method and content of the oncology clinical trial case report form(CRF) based on the clinical data acquisition standards harmonization(CDASH).METHODS:Compared with CDASH v2.2,the characteristics of oncology clinical trial data were analyzed,and a standardized CRF was designed to meet the actual needs of oncology clinical trials.RESULTS:The CDASH was applied to the design of the CRF of the oncology clinical trial,and the data collection of the oncology clinical trial was standardized,so that the CRF design of the oncology clinical trial was relatively standardized and the data quality was improved.CONCLUSION:The implementation of oncology CRF design based on CDASH can promote the exchange and sharing of oncology clinical research data,which is conducive to improving the reliability of oncology clinical research results.

关 键 词：临床数据获取协调标准 肿瘤临床试验 病例报告表 

分 类 号：R969[医药卫生—药理学]