Author(s): LEI Xiang, LIU Zhi, ZHAI Jing-bo, ZHENG Wen-ke, TIAN Ran, SHANG Hong-cai, Tianjin University of Traditional Chinese Medicine
Pages: 2276-2279
Year: 2014 Issue:  19
Journal: Chinese Journal of New Drugs
Keyword:  traditional Chinese medicine; clinical trial; positive drug; principle; method;
Abstract: In recent years,a large number of clinical trials of traditional Chinese medicine have been carried out in China and the trial quality has been improved continuously,but there are still many deficiencies.The selection of control drugs is the key to determine the success of clinical trials.Unreasonable control drugs will seriously affect the trial results,such as the comparability between drugs lacks,and the uncertainty of control drugs in their safety and activity.In this paper,we discussed the principles and methods of selecting the positive drugs in clinical trials.We believe that selecting the positive control drug needs to comply with the safe,effective and comparable principles,the selection process including analysis of the test purpose,screening of potential drugs,and consulting the experts.We hope to provide a reference for selecting positive drugs in future clinical trials.