倡议应用临床数据交换标准协会的治疗领域标准提高中医药治疗慢性阻塞性肺疾病的临床试验效率
Applying the CDISC Therapeutic Area Standards to Improve the Efficiency of Clinical Trials of Traditional Chinese Medicine for the Treatment of Chronic Obstructive Pulmonary Disease:An Initiative
赵文翰 1禤美玲 2李庚 2吴蕾 2温泽淮 3林琳3
作者信息
- 1. 广州中医药大学,广东 广州 510405;广州中医药大学第二附属医院,广东 广州 510120;广州中医药大学第一临床医学院,广东 广州 510006
- 2. 广州中医药大学第二附属医院,广东 广州 510120
- 3. 广州中医药大学,广东 广州 510405;广州中医药大学第二附属医院,广东 广州 510120
- 折叠
摘要
为了更好地促进临床研究数据标准化,临床数据交换标准协会(Clinical data interchange standards consortium,CDISC)建立了一系列临床研究数据标准,并于 2016 年 1 月发布了慢性阻塞性肺疾病(简称"慢阻肺")的治疗领域(Therapeutic area,TA)标准.该治疗领域标准用于确定慢阻肺临床研究方案的共性数据标准,支持不同来源、不同时期的临床试验数据整合,促进队列数据的二次分析.该文介绍了慢阻肺治疗领域标准用户指南的结构与内容,以帮助研究人员在研究设计中更好地理解和使用慢阻肺治疗领域标准,倡议应用该治疗领域标准来规范慢阻肺的中医药临床试验设计,以促进研究数据整合,提高临床试验效率.
Abstract
In order to better promote the standardization of clinical research data,the Clinical Data Interchange Standards Consortium(CDISC)has established a series of clinical research data standards,and issued the Therapeutic Area(TA)standard for chronic obstructive pulmonary disease(COPD)in January 2016.This treatment domain standard is used to identify common data standards for clinical research protocols for COPD,to support the integration of clinical trial data from different sources and at different times,thus to promote the secondary analysis of cohort data.This article introduces the structure and content of the standard user guide for the treatment of COPD,in order to help researchers better understand and use the standard in the field of COPD treatment in research design.It is proposed to apply the standard in the field of treatment to standardize the design of clinical trials of traditional Chinese medicine for COPD,so as to promote the integration of research data and improve the efficiency of clinical trials.
关键词
慢性阻塞性肺疾病/临床数据交换标准协会(CDISC)/治疗领域标准/中医药临床试验Key words
chronic obstructive pulmonary disease/clinical data interchange standards consortium(CDISC)/therapeutic area standards/clinical trials of traditional Chinese medicine引用本文复制引用
基金项目
广州市科技计划项目(2023A03J0226)
中华中医药学会青年求实项目(2022-QNQSDEP-04)
出版年
2024
NETL
NSTL
万方数据