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Objective To summarize the experience of the clinical research network operation mechanism in typical countries,and provide reference for the construction of China's national clinical research network.Methods Literature research method and the inductive analysis method were used to analyze the information on official website and literature materials of the clinical research network in typical countries to summarize their characteristics and experience.Results The clinical research network in typical countries had developed an optimized and efficient operational mechanism,including the development of information platforms,development of tools and templates,streamlined review processes,implementation of membership systems,establishment of sharing mechanisms,and complementary models of clinical centers and research institutes,stable sources of funds,establishing reward and punishment mechanisms,etc.Conclusions China's national clinical research network is still at the initial stage,government should make full use of the information platform,strengthen human resource input,and accelerate the research and exploration of more innovative management mechanisms.
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Objective To analyze the hot spots and frontiers in domestic and foreign precision medicine with CiteSpace. Methods The CNKI and WOS-covered papers on precision medicine were analyzed by bibliometrics combined with CiteSpace. Results Domestic precision medicine got off in 1992 and scholars became interested in it from 2010 . Foreign precision medicine started in 1985 and studies on it increased rapidly from 2006 . The node of precision medicine was the largest in China with a rather high value of gene mutation, US president Barack Obama ( precision medicine program) , personalized medicine, gene chip, genomics and pharmacogenomics whereas the node of personalized medicine, cancer and breast cancer was the largest with a rather high value of precision medi-cine, pharmacogenomics and pharmacogenetics. Conclusion The number of domestic and foreign papers on US president Barack Obama ( precision medicine program) is rapidly increased and pharmacogenomics is their common frontier. However, cancer is highly concerned in foreign countries.
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Objective Establish an objective and fair evaluation index system for the implementation effectiveness of the National Major New Drug Development Program of China.Methods Based on literature review and Delphi method,the framework of the evaluation index system was built and analytic hierarchy process was applied to determine the priority of each indicator of the system.The objectiveness and validness of the results were assured by determining expert activeness coefficient,authority coefficient,indicator rationality,and by applying consistency check.Results A targeted and systematic evaluation index system was constructed for the National Major New Drug Development Program,and through expert consultation and analytic hierarchy process,the factor of product result was considered of the highest weight of 39.03％,followed by technical result,theoretical result and organization and management result.The evaluation index system suggested that product result and technical result are two relatively more significant factors to be considered during evaluation.Conclu sion After consultation on expert opinions,the evaluation index system for the National Major New Drug Development Program was constructed with each factor been assigned with a scientific and rational weight,and this will provide a guideline for the decision making of program administrators and evaluation practice.