摘要
中国近年来,大量的资源被投入到抗肿瘤临床试验,国家药品监督管理局药品审评中心(CDE)陆续地颁布了多个针对肿瘤治疗领域的技术指导原则,旨在进一步规范国内肿瘤临床试验的开展和注册要求。数据是临床试验的基石,临床试验的结论非常依赖数据的完整与质量。本文根据肿瘤治疗领域试验的特点,结合临床数据交换标准协会(CDISC)建立的临床数据标准与已颁布的重要指导原则,介绍了针对肿瘤临床试验数据管理的一般考虑,旨在强调规范的采集数据,及时监测数据问题,以确保数据质量和研究结论的可靠。本文从复杂研究设计对病例报告表(CRF)的影响,遵循临床数据获取协调标准(CDASH)设计CRF,科学制定数据核查计划,滚动递交与数据截断等方面进行探讨。
With the enormous resources having been invested in oncology drugs development in China in recent years,the Center for Drug Evaluation(CDE)of National Medical Products Administration has been issuing a number of technical guidelines to further standardize the requirements on implementation and registration of domestic oncology clinical trials.As data is the cornerstone of clinical trials,data integrity and quality will directly decide the outcome of clinical studies.Given the specific characteristics of oncology therapeutic clinical trials,and combined with the clinical data standards established by the Clinical Data Interchange Standards Consortium(CDISC)and the issued industrial guidelines,this article introduces the general considerations of clinical data management for oncology clinical trials,with the aim of emphasizing normative data collection and timely data monitoring to ensure the data quality and reliability of results of the study.This article discusses the impact of complex study design on CRF,design CRF according to CDASH,develop DVP scientifically,rolling submissions and data cut-off.
作者
缪亚东
李蹊
王燕
高坡
周敏
于浩
MIAO Yadong;LI Xi;WANG Yan;GAO Po;ZHOU Min;YU Hao(Chia Tai Tianqing Pharmaceutical Group co.,Ltd,Nanjing 211122,Jiangsu,China;Duality Biologics,Shanghai 201204,Shanghai,China;Akeso Biopharma Co.,Ltd.,Zhongshan 528437,Guangdong,China;Lynk Pharmaceuticals Co.,Ltd.,Hangzhou 310018,Zhejiang,China;School of Public Health Nanjing Medical University,Nanjing 211166,Jiangsu,China)
出处
《中国临床药理学与治疗学》
CAS
CSCD
2022年第9期1055-1060,共6页
Chinese Journal of Clinical Pharmacology and Therapeutics
基金
国家自然科学基金(81773554)。
