Research On Quality Control Status And Influencing Factors Of Drug Clinical Trial In Shanxi Province

Objective:1. To understand the status of drug clinical trial quality control implementation of investigators of drug clinical trial institutions in Shanxi Province.2. To analyze the main factors affecting the status of drug clinical trial quality control implementation of investigators.Methods:Three main methods of literature research, survey and field research were adopted in this study. During the process of topic choosing, review writing, questionnaire designing and thesis writing, the author searched a large number of documents. Literature research method was also used in review of domestic drug clinical trial relevant laws and regulations and the text comparative study of international ICH-GCP and domestic GCP.Survey included questionnaires and interviews. The author did a survey among investigators of drug clinical trial institutions in Shanxi Province to find out the status and influencing factors of drug clinical trial quality control implementation; a survey among monitors, from the perspective of monitors, to reflect the status of drug clinical trial quality control implementation of investigators; interviews among drug clinical trial institutions managers and monitors to further know the status of drug clinical trial quality control implementation. Based on practice in a drug clinical trial institution of a top three hospital,method of field research was used to learn drug clinical trial relevant knowledge, the process of drug clinical trial, quality control elements as well as the IRB review process and participate in drug clinical trial quality management standardization training in Shanxi Province. Used the statistical method of statistical description, signed-ranks test,correlation analysis and factor analysis.Results:Through review of domestic drug clinical trial relevant laws and regulations as well asinternational ICH-GCP and domestic GCP text comparative study, the author found that the domestic drug clinical trial relevant laws and regulations system had gradually completed and revised constantly as the development of our times. Compared domestic GCP with international ICH-GCP, the author also found that there was gap in the content advancement, integrity and content operationality. The total average of quality control of investigators of different ages, titles, working years and drug clinical trial institutions has significant difference(P<0.05). From investigators’ perspective, the author realized that the scores of some indicators before the trial were not high, such as “Be familiar with and master the current GCP and other regulatory affairs(Q4)”, “To understand the different kinds of SOPs of trials(Q5)”, “Principal investigator drafts SOPs which are approved by the relevant departments, published and effectively executed(Q6)”, and so on. From monitors’ perspective, the scores of some indicators in the middle of the trial and after the trial were not high, such as “Laboratory tests complete and in accord with the requirements of trial protocols(Q18)”, “To designate an experienced laboratory technician to conduct the work of quality control(Q15)”, “To take appropriate measures to ensure compliance of subjects(Q39)”, and so on. The investigators and monitors rated the indicators of implementation status of drug clinical trial in the middle of the trial and after the trial. The correlation coefficients were 0.072 and-0.064 respectively. The results of interviews led to the result that there were still many problems in the status of drug clinical trial quality control implementation among investigators. Through factor analysis, the author summarized that the main factors affecting the drug clinical trial quality control implementation were as follows: hardware facilities and management of archives; the accuracy, completeness, reliability of data recording; compliance with protocols and informed consent process; awareness of laws, regulations and SOPs; investigators’ working attitudes of quality control; examination of abnormal values in trials.Conclusion:Based on the understanding of quality control status and influencing factors of drug clinical trial among investigators of drug clinical trial institutions in Shanxi Province, to improve the quality of drug clinical trial data and ensure the scientific and ethical requirements of trials, the author came up with following recommendations: to strengthen the GCP, other laws and regulations training as well as SOPs and enhance investigators’ professionalism; to establish complete quality control system and make clearresponsibilities of different personnel parties; to pay due attention to the management of trial files and enhance systems and hardware facilities; to strengthen team construction of Clinical Research Coordinators(CRC); to enhance the continue review of Institutional Review Board(IRB); to strengthen the use of information technology in drug clinical trials.