Application of umbrella design and basket design in evidence-based research for traditional Chinese medicine.
10.19540/j.cnki.cjcmm.20210204.501
- Author:
Xiao-Hui GUO
1
;
Qian HUANG
2
;
Yan-Ming XIE
3
;
Ze-Huai WEN
4
Author Information
1. Key Unit of Methodology in Clinical Research, Guangdong Provincial Hospital of Chinese Medicine Guangzhou 510120, China.
2. the Second Clinical College, Guangzhou University of Chinese Medicine Guangzhou 510120, China.
3. Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences Beijing 100700, China.
4. Key Unit of Methodology in Clinical Research, Guangdong Provincial Hospital of Chinese Medicine Guangzhou 510120, China Science and Innovation Center of Guangzhou University of Chinese Medicine Guangzhou 510405, China.
- Publication Type:Journal Article
- Keywords:
basket design;
master protocol;
traditional Chinese medicine;
umbrella design
- MeSH:
Dietary Supplements;
Medicine, Chinese Traditional;
Precision Medicine;
Records;
Research Design
- From:
China Journal of Chinese Materia Medica
2021;46(8):2010-2015
- CountryChina
- Language:Chinese
-
Abstract:
This paper introduced the basic definition, application scope, advantages and challenges of the master protocol, basket design, umbrella design and platform trial, and put forward the idea of using master protocol, basket design and umbrella design in Chinese medicine(CM) by considering the characteristics of CM and research experiences. The author pointed out that master protocol, basket design and umbrella design, as a high-efficiency research and design strategy, can be used in the clinical research on the treatment of the same disease with different therapies, the treatment of different diseases with the same therapy and the combination of diseases and CM syndromes. In particular, the exploration from the classification of CM syndromes can supplement the gaps in the cli-nical research on CM syndromes. In the application of such designs, it is also necessary to pay attention to their potential challenges and develop reasonable and feasible plans on research implementation, management and statistical analysis in advance to meet these challenges.
