Intelligent management of whole process of lymphoma drug clinical research
With the increasing of clinical research on lymphoma drugs,a variety of new clinical trial models have emerged,which have both benefits and challenges.This study explored an intelligent management model for lymphoma drug clinical research.Based on the existing scientific research big data platform and hospital information system of our hospital,combined with AI technology and the new version of GCP and other relevant regulations,an intelligent information management model was designed and implemented for clinical research of lymphoma drugs and continuously optimized,providing intelligent management support for the whole process of clinical trial implementation.It contains five main function modules:intelligent screening of subjects,intelligent marking,intelligent visiting,intelligent monitoring and intelligent quality control.This model provides full process research tools and services for drug clinical trial subjects and researchers.From March 2020 to June 2023,our hospital had used intelligent screening in four lymphoma drug clinical trial projects and intelligent quality control in 12 lymphoma projects,and used drug clinical trial subject management system to conduct protocol visits and online maintenance of 89 lymphoma clinical trial projects,with 442 subjects screened and 254 subjects administered with drugs.According to the intelligent visit plan,158 subjects were interviewed,and 73 subjects were followed up.Remote monitoring was used in 39 clinical studiesof lymphoma drugs,with 8 890 visits.After the initial practice and application,the system supports decision-making and auxiliary execution,standardizes the clinical trial process,protects the rights and interests of the subjects,and can improve the management efficiency and trial quality of drug clinical trials.It has initially achieved the expected goal of improving the quality and efficiency,and created favorable conditions for the standardized development of clinical research on lymphoma drugs.
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