Research On The Establishment Of Comprehensive Evaluation System For Clinical Trial Data Management

[Purpose] Standardized data management can provide true,complete,accurate and reliable high-quality data,which is an important demonstration of the safety and effectiveness of drugs.At present,the standardization of clinical trial data management in China leaves something to be desired,which further affects the objective scientific evaluation of the effectiveness and safety of new drugs.This study will build on the existing clinical trial data management related standards and combine domestic and foreign related research to build a comprehensive evaluation index system for clinical trial data management with a view to comprehensively evaluating clinical trial data management.[Methods] Examine existing regulations and literature related to clinical trial management,and select indicators for evaluating clinical trial data management.An expert group discussion method is adopted,and experts engaged in clinical trial management work are selected from the indicator framework to form a comprehensive evaluation indicator system.Adopt Delphi method for two rounds of expert consultation.Collect experts’ opinions on the importance of preliminary screening indicators and the modification of the indicator system.The boundary value method was used to screen the indicators based on expert scores,and finally a comprehensive evaluation index system for clinical trial data management was constructed.The reliability of the index system is evaluated using the coefficient of positiveness,authority,concentration of expert opinions,and the degree of coordination.Finally,the weight of each indicator is determined through the analytical hierarchy process.[Results] This study constructs an evaluation system from the three dimensions of structure,process,and results,and combines literature research and expert panel discussions to screen evaluation indicators.Select experts in clinical trial-related fields for expert consultation,modify the evaluation index system based on the expert consultation,modify the index 1,delete the index 4,the resulting index system includes 3 first-level indicators,12 second-level indicators,33 Three-level indicators.The index weights are calculated through the analytic hierarchy process.The three first-level index weights are: structure(0.2611),process(0.3278),and result(0.4111).[Conclusions] This study explores the application of the SPO model to the construction of a comprehensive evaluation system.It is feasible to construct a comprehensive evaluation index system for clinical trial data management from the three dimensions of structure,process and results.Among them,the pharmaceutical company’s data management for clinical trials should start from the research design through the entire research process.The clinical research data management should pay attention to key links such as data entry and quality control to improve the complete consistency and accuracy of clinical research data management.Overall improve the quality of clinical research.