| Objective:Improve the quality of innovative drug clinical trials, and promote drug independent research is the inevitable requirement of conforming to economic and social development, and building the innovative country in China. At present, the institutions of clinical trial for innovative drug’s risk control ability is weal. This study aimed to build a set of innovative drug risk management evaluation system accord with national conditions by analyzing the drug trial situation and existing problems and referring to the relevant laws and regulations of international organizations and developed countries, so as to provide scientific reference from multiple perspective to reduce the risk of innovative drug clinical research.Method:1. Literature analysis and comparative study:this study conducted a comprehensive literature review on domestic and international innovative drug clinical trial laws and regulations, and analyzed the specific characteristics of innovative drug clinical trial laws and regulations among China, America and other international organizations to find out the gaps of management and supervision system between China and others, meantime to indentify the weakness.2. Questionnaire survey and expert consultation:drug clinical trial institution innovative drug risk management evaluation system consultation questionnaire was designed by the results of literature analysis and expert consultation.30experts who were working at pharmacology, pharmaceutical analysis, clinical medicine, hospital administration, biometric, drug registration and other related fields participated in this research, and analyzing the results of survey.3. Synthetical evaluation:the study initial built a functions and quality assessment dimensions and indicator sets of innovative drug risk management in drug clinical trial institutions in China on the basis of literature review and expert interview. By E-mail and letter presented to way to the30experts about two rounds of consultation, determining the weight distribution of the best option. Then the evaluation index system at all levels of indicators of quantitative and assignment, and the indicators and standardized method. Proved this study, a comprehensive score for evaluation model constructed with the traditional models, have good consistency in the present study. This comprehensive score evaluation model can be as a comprehensive evaluation method of innovative drug clinical trials risk management.4. Date processing and statistical analysis methodologies:data of questionnaires were input to Excel to verification. To descript and infer the results of questionnaires, and analysis the authority degree and coordination coefficient of expert and so on.Result:1. This study investigated the situation of innovative drug clinical trials in China,1929trials were completed in73hospitals. According to the regional division, mainly innovative drug clinical trials concentrated in economically developed provinces, such as Beijing(512), Shanghai(259), Guangdong(249), Zhejiang(185). According to the drug register, mainly were chemical medicine(1379,71.5%). According to the system, mainly were anti-infection(318,16.5%), tumor(372,19.3%), cardiovascular system(254,13.2%), endocrine system(187,9.7%) and respiratory system(165,8.6%). According to the stage, mainly were III phase(959,49.7%). Investigation showed that ethical committee pay much attention to the innovative drug clinical trial ethical review,1474(76.4%) trials passed review in many ways.760(39.4%) trails were multi-center trials, the domestic multi-center and international multi-center trials half proportion. About35%sponsors were foreign enterprises,22.6%trials were equipped with clinical research coordinator.22%trials used the electronic case report. Most principle investigator had senior titles,52.5%had doctoral degree and79.5%had innovative drug clinical trial experience.2. Through the study of the United States and other developed countries and international organizations’innovative drug clinical trial supervision system and related laws and regulations showed that the related regulations had the high legal status, but low in China. In the respect of records management, ICH countries pay much attention to collecting and recording data. The federal laws had specific regulation clause (21CFR56,106.3) for ethic committee, but lack in China. Meanwhile, the regulations in China lack of corresponding flexibility so against the development of international multi-center project in China.3. This study summarized some problems of drug clinical trials though analyzing the result of clinical trial institution inspecting data. Mainly problems of institutions were quality assurance system (42.5%), such as: SOP for quality assurance fail to revise, operability not strong and quality control and assurance system imcomplete. Mainly problems of ethics committee were the ethical review and the operability of SOP(13.4%). Mainly problems of majors were clinical trials investigator (34.3%), such as: investigator had no qualification and experience. Mainly problems of trials project were trials records, such as:trial recorded not timely and correct, rectification of trial record imcomplete.4. This study preliminarily built a set of index system by literature review and expert interview, then conducted two rounds of expert consultation and revised these indexes according to the expert opinion. At last, index system including the risk of organization, project management, quality assurance and process management with4dimensions,16items and98indicators was built. Then according to the results of literature and expert interview, re-conducting two rounds of expert consultation determined the weight for all indicators, in which4dimensions of A to D were0.25. On this basis, building a comprehensive score evaluation model. Two rounds of expert consultation had30experts, and in the analysis of the characteristics of consultants found that the authority of this high level of expert advice, good co-ordination. The empirical study found that10hospital rankings are (high to low):I, G, H, J, E, F, B, D, A, C(using this study evaluation model); I, J, G, H, B, E, C, F, A, D(using the weighted rank sum ration method); I, G, H, J, D, C, B, E, F, A(using the weighted TOPSIS method). Correlation analysis showed that three methods had good consistency (correlation coefficients were0.830and0.733).Conclusion:1. The current situation and problems of the innovative drug clinical trial were analyzed in detail in this study. The level of clinical trial research had significant improved. There were19provinces and cities to carry out new innovative drug clinical trial, and the number of trial increased significant. Most of institutions set up independent ethic committee. However, the results showed that the varieties of trail less, lack of Chinese medicine, information level lower and so on. Agency problems mainly focus on the quality management system, personnel qualification level, but hardware level problems were less, causing most institutions had non-standard records. Therefore, establishing a set of risk management evaluation system of innovative drug clinical trial was necessary.2. This study compared the clinical trial supervision system in China and the federal law and WHO guidelines. The result showed that all the guidelines had the same principle and content, even stricter n some detailed regulations. However, the result also showed that the legal status of clinical trials, data collection, records and documentation saving and ethics committee responsibilities was worth to learn and reference in China.3. This study proposed evaluation of initial evaluation index set by searching the domestic and foreign clinical trial regulations and other literature, and conducted two rounds of expert consultation, finally building the innovative drug clinical trial risk management evaluation system structure. In empirical study, randomly selected10hospitals to study that using the model structure that this study improved and two traditional methods. The result showed that this evaluation system structure had scientificity and feasibility by empirical research.Innovation point:1. Multi-analysis and research the current situation of innovative drug clinical trials in China firstly;2. Multi-analysis the clinical trial supervision system in China and the federal law and WHO guidelines firstly;3. Establish the risk management evaluation system research of innovative drug clinical trials in China firstly;4. Use the methods of literature review, current research, comparative study, expert interview and comprehensive evaluation method to built the risk management evaluation system. The experts came from all the relative fields, and had high authority and representation. |
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