Research On The Pediatric Clinical Trials Management Mode

Recently, pediatric drug shortage gets wide attention. Many parents and doctors are disappointed for the lack of pediatric information in drug labels, and the suitable dosage form for child. As a key procedure in drug development, the clinical trials in China seem in chaos, especially pediatric clinical research. Many problems exist in Chinese clinical trials:Poor compliance of clinical investigators and subjects, low level of data collection&analysis, the statistical method is not science-based, institutional review board perform practically no function, and the absence of government administration. As a vulnerable group, children is different from adult psychologically and physiologically, and pediatric trials require sophisticated protocol design, want more energy from investigators, and especially complicated in ethical review and informed consent.Objective:Based on the analysis of current status, we try to understand the whole procedure of clinical trials, learn from lessons from developed countries, and construct a feasible pediatric clinical trial management mode.Content&methodologyBased on literature search and expert review, we analyze the pediatric clinical trials in the USA, Europe and Japan; the related laws, regulations and guidelines; their administration on clinical trials, problems and achievements, then we summarize the management and administration mode of pediatric clinical trials.Through questionnaires, literature review and expert interview, we also analyze the pediatric clinical trials in China, the whole operation of clinical trial sites management, and the policies.Through the comparative analysis, we try to summarize the problems of Chinese pediatric clinical trials.We conduct the structural equation model to find the factors in Chinese pediatric clinic trials management. At last we construct the Chinese clinical trials management and administration mode.Result&analysis:In developed countries, the policy and financial investments in clinical trials especially pediatric CTs are very attractive, increasing the clinical trails in children, and so the pediatric information in drug labels, and even the number of pediatric drugs.In the USA, Europe and Japan, the social division in clinical trial is delicate, the protection of subject is comprehensive, regulation on clinic trials is dynamic, and its punishment is very tough. With the increasing the objects, high volume of workload, scarce administrative resource, the administrative agencies in developed countries sought to improve administrative efficiency through new technologies. Their administrative objects include institutional review board, CT site, clinical investigators, sponsors and contact research organizations. Recently, pharmaceutical industry begins to seek risk-based administration, and promote science-based administration.There49pediatric clinical trials institutions in China, among them10institutions are specialized hospitals for children,17are traditional Chinese medicine (TCM) hospitals, most of them are in big cities such as Beijing, Shanghai; our survey indicates that their patient resource is rich; pediatric respiratory, traditional Chinese medicine are the two most popular ones in pediatric clinical trials.From the survey, we find that the independence of IRB in China is by no means guaranteed, the idea of subject protection is very weak in investigators, sponsor and administrator. Besides, traditional Chinese medicine is very prosperous. The certification of clinical trials agency is very casual, causing the difference in the management level of the existing institutions.Mainly, there are4factors impact the pediatric clinical trials in China-government administration, hospital management, sponsor/CRO administration, subjects/social behavior. The result of our model show:(1) hospital management and government administration play an important role in clinical trials;(2) sponsor/CROs has no impact on CTs, which indicate that sponsor/CROs should improve their clinical trials;(3) Social environment is greatly influenced or directed by government, so government could do more to guide the social media, to give people more information about the clinical trials.Conclusion&suggestionGovernment should administrate the clinical trials more rigorously:(1)Perfect the legal system in pediatric clinical trials;(2)Enhance the administrative resources;(3)strengthen the administration on sponsor/CRO;(4)explore science-based administration. Clinical trial sites should guarantee the quality of clinical trials by them:(1) Unify the management of investigational drugs;(2)focus on the strategy of pediatric clinical trials;(3)communicate more with the media about the clinic trials;(4) establish the quality control mode in clinical trials hospital. IRB should do more to protect the subjects:(1) IRB should be independent, could be established in universities;(2) guarantee the compliance of IRB;(3)enhance the administration and evaluation of IRB. Sponsor and CRO/SMO should contribute more to the clinical trials:(1)improve the protocol design of domestic clinical trials;(2) try to explore the centered monitor system;(3)construct the clinical research coordinator system.InnovationsWe find the factors impact the pediatric trials in China and their mechanisms through the full-sample survey. Futher research could explore the factor within hospitals and their contribution to pediatric clinical trials.