CDISC治疗领域及冠心病心绞痛中医药治疗领域数据标准的开发

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英文篇名：Research and Development of Data Standards of CDISC Therapeutic Area and TCM Therapeutic Area of Angina of Coronary Artery Diseases 作者：李庆娜 ; 唐旭东 ; 陆芳 ; LI ; Jordan ; 徐浩 ; 毛静远 ; 赵阳 ; Diane ; Wold ; Rhonda ; Facile ; 陈君超 ; 彭瑞玲 ; 高蕊 英文作者：LI Qingna;TANG Xudong;LU Fang;LI Jordan;XU Hao;MAO Jingyuan;ZHAO Yang;Diane WOLD;Rhonda FACILE;CHEN Junchao;PENG Ruiling;GAO Rui;Institute of Clinical Pharmacology, Xiyuan Hospital of China Academy of Chinese Medical Sciences;National Cancer Institute, Enterprise Vocabulary Services;Center of Cardiovascular Disease, Xiyuan Hospital of China Academy of Chinese Medical Sciences;Department of Cardiovascular Disease, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine;Clinical Data Interchange Standards Consortium;Center for Drug Clinical Research, Shanghai University of Chinese Medicine;Beijing Improve-Quality Technology Co., Ltd.; 关键词：临床数据交换标准协会标准 ; 治疗领域数据标准 ; 中医药 ; 临床研究 ; 冠心病心绞痛 英文关键词：CDISC standards;;data standards of therapeutic areas;;TCM;;clinical study;;angina of coronary artery diseases 中文刊名：XXYY 英文刊名：Chinese Journal of Information on Traditional Chinese Medicine 机构：中国中医科学院西苑医院临床药理研究所;美国国家癌症研究所企业词汇服务中心;中国中医科学院西苑医院心血管病中心;天津中医药大学第一附属医院心血管科;(美国)临床数据交换标准协会;上海中医药大学药物临床研究中心;北京医普科诺有限公司; 出版日期：2019-02-15 出版单位：中国中医药信息杂志 年：2019 期：v.26;No.295 基金：国家科技重大专项-重大新药创制(2017ZX09304003);; 中医药临床研究与培训国际合作基地(北京)(GZYYGJ2017010);; 中国中医科学院西苑医院苗圃课题基金资助项目[XYKY-MP(2013)-38] 语种：中文; 页：XXYY201902003 页数：5 CN：02 ISSN：11-3519/R 分类号：15-19

摘要

临床数据交换标准协会(CDISC)制定了一系列规范临床和非临床研究数据的基础标准,以合理化数据的收集、管理、分析、报告和提交流程。目前,多国药监部门、制药企业及学术单位普遍采用CDISC标准。为加速对公共健康有重大影响的疾病领域相关临床研究数据标准的开发,自2012年起,CDISC开发治疗领域(therapeutic areas,TA)数据标准,目前已发布20余个TA标准。相较于CDISC基础标准,国内用户对TA标准的熟知度偏低,本文介绍了TA标准与其他CDISC基础标准的关系、TA用户指南的一般结构、TA标准开发流程,以及冠心病心绞痛中医药治疗领域数据标准项目开发情况,并讨论开发过程面临的主要困难,旨在向国内用户介绍CDISC的TA数据标准,并为其他中医药TA数据标准的开发提供参考。
        Clinical data interchange standards consortium(CDISC) has developed a series of fundamental data standards for organizing and formatting clinical and nonclinical research data to streamline processes in collection, management, analysis, reporting and submission. At present, CDISC standards have been adopted by global regulatory agencies, pharmaceutical and academic communities. To accelerate the development of clinical research data standards for specific disease areas that are important to public health, CDISC began to develop therapeutic area(TA) data standards starting from 2012 and since then, more than 20 TA standards have been released. In comparison to fundamental standards, TA standards are less known within the Chinese user community. This article introduced the relationship between TA and fundamental standards, the general structure of a TA user guide(TAUG), the steps required for the development of TA standards and the TCM TA project-angina of coronary artery diseases. In addition, main problems in the process of development are discussed, with the purpose to introduce the CDISC TA standards to the Chinese domestic users and provide a reference for other TCM TA projects.

引文

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