Analysis On The Topic And Evolution Path Of Clinical Trial Management Research In China

Objective:To improve the basic theory of clinical trial management,explore the main research topics in the field of clinical trial management in China,analyze the evolution process of hot topics,reveal the research status of clinical trial management,and clarify the development context of hot research topics.Methods:Based on the literature research method,the basic process of clinical trial was sorted out,the factors of clinical trial management were refined,and the basic theory of clinical trial management was improved.The Latent Dirichlet Allocation(LDA)model is used to determine the main research topics in this field.Hot topics are identified by the topic life cycle coordinate method.The evolution of the topic content is analyzed based on the keywords of the literatures of hot topics in different development stages.Results:The core factors involved in the three stages of clinical trial include environmental factors,personnel factors,hardware factors,software factors,process factors and result factors.Clinical trial management is the coordination,control and management of all core participating factors to maximize clinical trial benefits.There are13 main research topics in clinical trial management in China.According to the research content,it can be divided into two categories: quality management of clinical trials and protection of the rights and interests of clinical trial subjects;According to the development type of the theme,it can be divided into four potential themes with further development potential,five declining themes with differentiation tendency and four hot topics.The evolution of hot topics not only has its own characteristics,but also presents some common characteristics.Conclusion:In this paper,based on the theories of management and clinical trial,the basic process of clinical trial was analyzed,the core participation factors were extracted,and a relatively complete basic theory of clinical trial management was constructed.Research on clinical trial management in China has developed rapidly in recent years.Hot research topics show that: current clinical trial management research mainly focuses on clinical trial institutions and subjects,and takes information management system as an important means.The evolution analysis of hot topics shows that the management of clinical trial institutions in the early stage mostly focused on the quality control of clinical laboratories,while at present,more attention is paid to the management of micro-factors such as funds,human genetic resources and protocols.The research focus of clinical trial information management system has changed from the design of data management system to the design of platform compatible with multiple management systems.Research on the protection of subjects’ rights and interests currently focuses more on the rights and interests of subjects in clinical trials under the influence of epidemic prevention and control.The study of subject compliance management mainly focused on the physical intervention of subjects in the early stage,but now it pays more attention to the psychological intervention of subjects.