Key Points of Ethic Review on Clinical Trials of Traditional Chinese Medicine
- VernacularTitle:中药新药临床试验伦理审查应关注的问题
- Author:
Mingjie ZI
;
Rui GAO
;
Weiliang WENG
;
Tao LI
;
Bo LI
;
Xudong TANG
- Publication Type:Journal Article
- Keywords:
Traditional Chinese Medicine;
Clinical Trials;
Ethical Review;
Ethical Issue;
Ethics Committe
- From:
Chinese Medical Ethics
2014;(2):183-185
- CountryChina
- Language:Chinese
-
Abstract:
According to the common standard of ethic review for clinical research , it is equal to each kind of research program whether western medicine or Traditional Chinese Medicine .It should be reviewed the ethic and scientific issues in the same time .However, on account of the two majority characteristics of Traditional Chinese Medicine , it would be concerned more evidence , such as the safety data before clinic , the syndrome differentiation and treatment of target disease , drug combination , dosage and course of treatment , the methods of outcome meas-urement, admixture of the drug, the selection of control drug including placebo and so on .