Research On Management Status And Strategies Of Drug Clinical Trial Institution

Objective:This thesis aims to know the current status of management of DrugClinical Trial Institution in China, and have a good grasp of micro-management mechanism, to analyze the main factors on functioning. Based on this, some feasibility proposals for promoting the level of management of Drug Clinical Trial Institution in China are provided.Methods:Theories and methods of Management Science, health policy and health statistics are used in this study, The main methods include: (1)Literature research method; (2)Questionnaires survey; (3)In-depth interviews;(4)Health statisticalmethods: descriptive statistical methods,Chi-square test,logistic regression,topsis comprehensive evaluation method, correspondence analysis and so on are included to analyze the results of questionnaires survey and In-depth interviews.Results:1. Hospitals attach much importance to the Drug Clinical Trial Institution, the person who are responsible to the institutions are mostly presidents or vice-presidents who in charge of scientific research, account for 80%. The hardware of the institutions are generally good, 100% in line with the eligibility criteria forDrug Clinical Trial Institution, while there are differences in the aspects of organizational structure and number of personnel; the personnel structure of EthicsCommittees in the institution are reasonable, but there are also differences in the meeting cycle and the fee of ethic among institutions. 10% of Ethics Committees hold 2 or more ethical meetings in one month, 60% hold once, and 30% have one meeting in 2 or 3 months or above. The minimum fee of ethics committee is 400RMB per item; the maximum is 6000RMB per item, the expenses standard 2000-3000RMB per item which accounts for more than 80%. Ethical dynamic monitoring system is not sound and in lack of course supervision.2. Clinical Monitors approve of the Management of the Institutions. They adopt 10 scores system to evaluate the following indexes, the average scores are as follows: academic attitude is 7.44, the attitude of cooperation and exchange with the监查员approach to 7.46, overall project management is 7.25, project progress is 6.98, project quality control is 7.38, the comprehend capability is 7.39; topsis comprehensive evaluation results show that: Jiangxi, Guangdong and Shandong provinces ranked before other provinces; there is no standards in the participation of clinical promoting, the transfer and payment of drugs, trial progress monitoring and quality control among Institutions, so it is difficult to guarantee the trial quality.3. The overall satisfaction rate of Institution's services is 61.66%, logistic regression analysis: the explanatory variables into the model are quality control, coordination, efficiency and attitude of service, the parameters sign are all positivewhich indicate the positive correlation with the overall satisfaction. the sequenceof value of odds ratio OR showed: impact of the overall satisfaction from strong to weak is: efficiency of work (5.065), the coordination of work (4.723),quality control (4.012), attitude of service (2.999), the value of odds ratio OR is more, the impact to the probability of satisfaction evaluation to the monitor is greater.4. The training of investigator has to be further strengthened, 82% of the investigators have received relevant training in GCP, while there are 18% of investigators who have not received relevant training in GCP but still in the work; the most important factor influenced the quality of the study is the hospitals did not attach importance to it and the investigators were rather busy, and the most important factor influence the progress of trial is the difficulties for the patients recruitment; investigators'overall satisfaction rate to institutions is 77.78%,the reasons of the investigators are not satisfied with the institutions are mainly reflected in the three areas---hardware construction, the degree of attention, the small number of person who work in drug clinical trial institution.Suggestions:(1) Improve standards to access to, carry out dynamic monitoring, strengthen the quality certification of drug clinical trials institutions;(2)Establish ethics code of drug clinical trials in accordance with international ethic principles of the human body biomedical; (3) Strengthen the work of co-ordination and communication, Implement customer satisfaction strategy to improve the service attitude, Carry out full quality management, guarantee the quality of clinical trials;(4)Streamline workflow, to speed up the velocity of information office system, improve efficiency;(5) improve the organizational structure, enhance the work of training and further education, enhance the institution's construction hardware, Establish an effective performance evaluation system, raise the enthusiasm of researchers.