Chinese medicine clinical trial protocol design and report specifications.
- Author:
Mei HAN
;
Guo-Yan YANG
;
Yu-Yi WANG
;
Jian-Ping LIU
- Publication Type:Journal Article
- MeSH:
Clinical Trials as Topic;
Drugs, Chinese Herbal;
therapeutic use;
Humans;
Medicine, Chinese Traditional;
Research Design;
standards
- From:
Chinese Journal of Integrated Traditional and Western Medicine
2014;34(8):907-910
- CountryChina
- Language:Chinese
-
Abstract:
Clinical trial protocol is the document that illustrates the background of a clinical trial, theoretic basis, objective, design, methods, and organization, as well as statistical calculating, implement, and conditions for completion. Clinical trial protocol is the basic measure for ensuring the validity of scientific results and reducing bias. In order to optimize the design of clinical trial protocol, we generalize main problems in Chinese medicine clinical trials, key points of clinical trial protocol, as well as report standards.
