Application Study On Placebo-controlled Designed In Clinical Of Newlydeveloped Drug Of Chinese Material Medica

Objective:To illustrate the necessity of applying placebo control in the clinical trails of newly-developed drug of Chinese material medica, and to establish the standard of trial design and statistical analysis based on the placebo-controlled design preliminarily.Methods:1. Literature studyThrough study on the neoteric literature of multi-center clinical trails about newly-developed drug of Chinese material medica, analyze the problems existed in the scheme which designed as positive or dose controlled. Investigate the necessity of applying the placebo control, and demonstrate the methodology of designing as the placebo-controlled.2. Demonstration study on placebo-controlled designed in clinical trials of newly-developed drug of Chinese Material MedicaThe clinical trail of applying Haitao Ganzhining Capsule to treat simple nonalcoholic fatty liver (pattern of phlegm and stasis obstructing collaterals in TCM) was taken for demonstration. Through application of placebo control in phase II stage one and Dongbao Gantai Tablet as positive control in phase II stage one and phase III, the necessity of using placebo control in the clinical trail of new drugs was further illustrated, the influences of different design modes on the efficacy evaluation of newly-developed drug of Chinese Material Medica were thoroughly studied, and related evaluation methodologies were analyzed and summarized.Results1. Research on the necessity of applying placebo control in the clinical trails of newly-developed drug of Chinese Material Medica:A. There are valid evidences that previous clinical trails of positive control of Western medicine were not carried out according to the stratified analysis of patterns of Chinese medicine. B. Most of the positive controls of Chinese Material Medica have not undergone strict clinical trails, or not undergone clinical trails with placebo control.C. The different conditions between the previous clinical trails and the present clinical trails make the efficacy of the drugs used in positive control become indefinite under present trail conditions.2. Research on the evaluation methodology of clinical trails of newly-developed drug of Chinese Material MedicaIn the course of efficacy.evaluation of multi-center clinical trails, method of multiple linear regression deducting centrality can be used for measurement data before efficacy judgment based on clinical border value is made. At present, there is no evaluation method of grouped data based on clinical boundary value with regarding to centrality.3. Demonstration research on evaluation methodology of newly-developed drug of Chinese Material Medica based on the placebo controlAnalysis and comparison were done on grouped data and measurement data by applying multiple statistical analysis methods and efficacy evaluation methods. Ultimately, u test of clinical trails in phase III based on the clinical boundary value was finally concluded:The curative effects of the two groups with liver ultrasound and patterns of TCM as index respectively are equivalent.Conclusions1. Placebo control should be established in the clinical trails of newly-developed drug of Chinese Material Medica in order to guarantee absolute efficacy of newly-developed drug of Chinese Material Medica.2. In the course of statistical analysis of newly-developed drug of Chinese Material Medica in clinical trails, different methods of statistical analysis should be used according to different applicable circumstances. As for efficacy evaluation of newly-developed drug of Chinese Material Medica, evaluation result based on clinical boundary value is the focus of clinical research, while the result of statistical analysis is no longer important. Therefore, the significant state of clinical boundary value in efficacy evaluation of newly-developed drug of Chinese Material Medica is established.3. The statistical analysis norm of clinical evaluation of newly-developed drug of Chinese Material Medica based on placebo control is preliminarily established.