Developmental status and considerations of global clinical trial systems
By comparing China's and foreign expanded clinical trial systems from different perspectives,summarizing the successful experience of foreign countries,suggestions are provided for the further improvement of the expanded clinical trial system in China.Through the methods of literature research,comparative research,historical research and other methods,the domestic and foreign extended clinical trial system were studies and found that the extended clinical trial system systems of Europe,the United States and other countries/regions have been relatively complete,and the scope of application,application process and payment of fees are clearly stipulated.The use and management of extended clinical experimental drugs were standardized,making critically ill patients get timely treatment.However,China is still in an initial stage,and there are many problems in the implementation process.For example,the implementation of the expanded clinical trial system is affected by the imperfection of the system,the simplification of the application sponsor and the fee payment,as well as the ethical problems in the trial process.It is suggested that on the basis of improving the relevant laws and regulations of the extended clinical trial system in China,strict process supervision should be implemented through multi-party cooperation to resolve the difficulties of application initiation,improve the efficiency of review,and reduce the risks of trial operation,so as to further improve and perfect the extended clinical trial system in China.
expanded clinical trial systemsystem developmentthinking and suggestionssympathetic medication
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