Study On Quality Control In Drug Clinical Trial And Its Determinants

Drug clinical trial (DCR) is to point to evaluate the efficacy and safety of drugs in the human body (patients or healthy volunteers), in order to confirm and reveal the experiment with the effect of medicines and adverse reaction, etc. Clinical trials on evaluation of new drug efficacy and safety play an irreplaceable role. The research data and results are important basis for SFDA (State Food and Drug Administration), Drug clinical trials provide effective safeguard to improve people's health level.This study uses theoretical analysis and empirical analysis, qualitative analysis and quantitative analysis methods in order to explore relevant factors which affect drug clinical trials quality control. The research uses stratified random methods of extraction in Shandong Qilu Hospital and Shandong University of Traditional Chinese Medicine Hospital. The questionnaire is made up of 7 factors, obtaining informed consent, researcher's adherence, data record, checking of unusual values in laboratory examination, subjects compliance, drug management, adverse events processing, in order to explore related factors which affect drug clinical trials.Statistical methods:descriptive statistics, frequency analysis, reliability analysis and single factor analysis of variance, etc.Results showed that a rich experienced doctor may not do better than general researchers, in the aspects of" researchers adherence, data record, checking of unusual values in laboratory examination, drug management, adverse events processing", etc. That's because to regulate into practice is more important than understanding of GCP. But in the aspects of "obtaining informed consent, subjects compliance", as the growth of the researchers age, working time, subjects pay more trust.According to this conclusion, we put forward the following Suggestions: strengthening the quality control system of drug clinical trials; perfecting the standard operating procedures; strengthening the supervision function of ethics committee; establishing training system; strengthening the drug management of clinical trials; promoting tertiary quality control system; strengthening the control of laboratory data quality.