| Clinical trial is an important part in the process of new drug development. Clinical trial on the human subjects is to assess the safety and effectiveness of the new drugs, and to provide an important evidence for the approval of new drugs going to market. Improving the quality management of clinical trials, ensuring the accuracy and reliability of the data and results, and protecting the rights and welfare of the subjects are the important requirements of clinical trial. In the International Conference Harmonization-Good Clinical Practice (ICH-GCP) and SFDA-GCP, there are specific requirements of quality management in clinical trials. Under the globalization of drug market, the number of clinical trials has rapidly increased worldwide. In China, there are more and more clinical trials in recent years, especially there are more and more international multi-center clinical trials. This requires we should pay more attention to the quality management of clinical trials. However, there is no standardized evaluation index or evaluation method for quality management of clinical trials in China, and little is known how to evaluate the quality management of clinical trials. This study analyzed the current status of clinical trial management, and built the evaluation index system and comprehensive evaluation model of clinical trials in China. Meanwhile, we conducted the empirical study of10clinical trials to verify the method of comprehensive scoring was the reliable method to build the comprehensive evaluation model of clinical trials.This study conducted a literature review on quality management and quality evaluation of clinical trials in China and at abroad. It concluded the development of clinical trials, GCP, and quality evaluation of clinical trials.This study conducted the questionnaire survey to the clinical trial center administrators, investigators, and monitors to clarify the current situation of quality management of clinical trials. Totally,279copies of questionnaire were distributed. The data collected from the questionnaire survey was analyzed by software SPSS16.0. Through the factor analysis by SPSS16.0, the result showed the factors affecting the quality management of clinical trials focused on the management model, human resource, drug management, facilities, and management effect. Through the one-factor variance analysis by SPSS16.0, this study compared the quality management of clinical trials in three regions of China (the east region, the middle region, and the west region). The result showed,11index had the statistical significance in the regional differences, and the regional differences focused on the aspects of human resource, quality management model, and drug management.This study used the methods of literature review, in-depth interview, questionnaire survey, expert consulting, as well as system analysis to build the evaluation index system of quality management of clinical trials. The randomly selected two clinical trials were evaluated by the evaluation index system which is in the developing process. The result:Cronbach's alpha was0.987, Split-half was0.924. It demonstrated this evaluation index system of quality management of clinical trial had good internal consistency.We conducted twice expert consultations by the questionnaire developed in the study. At the first time of expert consultation, we distributed the copies of questionnaire to40experts,38experts returned the copies (the return rate was95%), of which38experts effectively completed the questionnaire survey (effectiveness rate was100%). At the second time of expert consultation, we distributed the copies of questionnaire to40experts,40experts returned the copies (the return rate was100%), of which40experts effectively completed the questionnaire survey (effective rate was100%). The background of the experts were:cardiology(8), oncology (4), neurology (4), gynecology (4), rheumatology (3), urology (2), hematology (2), gastroenterology (2), respiratory medicine (2), endocrinology (2), dermatology (1), geratology(1), pharmacology(1), statistics(1), bioethics(1), health management(1), nursing(1). They worked at the research institutions, hospitals and health administrations. There35professors and5associated professors.The positive coefficient, variation coefficient, and coordination coefficient were adopted to test the credibility of Delphi method. The results showed the expert advice were in good consistency. According to the expert advice, the relevant index were revised, and then finally built the evaluation index system of clinical trials. This evaluation index system contained three dimensions:constructure, process and result, and there were3first-level index,20second-level index, and82third-level index. The coordination coefficient of the second time expert consultation was>0.5(P<0.5). Basing on the score of the second time expert consultation, the weight coefficient and combinational weight coefficient were calculated.The comprehensive evaluation model of clinical trials quality management was built by the method of comprehensive scoring. In this model, the total score of the clinical trial was calculated by the method of weighting. It meant the sum of score of each index by its combinational weight was considered as the final evaluation result.Basing on the evaluation index system, this study evaluated the quality management of randomly selected10clinical trials by the methods of comprehensive scoring, TOPSIS and comprehensive index. Among the10hospitals,2were special hospitals and8were comprehensive hospitals;3were municipal hospitals and7were provincial hospitals;5were affiliated hospitals with the universities and5were teaching hospitals. In each hospital, we randomly selected2administrators,1PI,4investigators,1CRC,1ethics committee member and1CRA to participate in the questionnaire survey to evaluate the quality management of the selected clinical trial. We totally distributed the copies of questionnaire to100people of which96people returned the copies (effective rate was100%).The rank of the quality management evaluation of10clinical trials by the method of comprehensive scoring from high to low was:clinical trial2, clinical trial3, clinical trial7, clinical trial8, clinical trial1, clinical trial6, clinical trial4, clinical trial5, clinical trial9, clinical trial10. The average score of phase â…¡ and â…¢ studys was91.81, the average score of phase â…£ studys was89.69(P=0.606). There wasn't statistics meaning of their differences. The average score of national studys was91.02, the average score of international multi-center studys was92.59(P=0.006). There was statistics meaning of their differences. The average score of the studys in head sites was91.91, the average score of the studys in branch sites was90.83(P=0.697). There wasn't statistics meaning of their differences.The result of the correlation test among the methods of TOPSIS, comprehensive index and comprehensive scoring showed, the correlation was0.918(P=0.000) between the methods of TOPSIS and comprehensive scoring, and the correlation was0.997(P=0.000) between the methods of comprehensive index and comprehensive scoring. It demonstrated that the method of comprehensive scoring highly related to the methods of TOPSIS and comprehensive index, and the method of comprehensive scoring was reliable. It also demonstrated that the comprehensive evaluation model of clinical trials quality management which was developed basing on the method of comprehensive scoring in this study was reliable.According to the research findings, this study explored the quality management model of clinical trials which was complying with the ISO9001quality management standard. Meanwhile, under the national project of "new drug development", the potential opportunity for the improvement of quality management of clinical trials was analyzed.
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