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
10.19378/j.issn.1003-9783.2024.08.017
- VernacularTitle: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
- Author:
Wenhan ZHAO
1
,
2
,
3
;
Meiling XUAN
;
Geng LI
;
Lei WU
;
Zehuai WEN
;
Lin LIN
Author Information
1. 广州中医药大学,广东 广州 510405
2. 广州中医药大学第二附属医院,广东 广州 510120
3. 广州中医药大学第一临床医学院,广东 广州 510006
- Keywords:
chronic obstructive pulmonary disease;
clinical data interchange standards consortium(CDISC);
therapeutic area standards;
clinical trials of traditional Chinese medicine
- From:
Traditional Chinese Drug Research & Clinical Pharmacology
2024;35(8):1255-1263
- CountryChina
- Language:Chinese
-
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.
