Construction and application of clinical research data standard for lymphoma
MI Lan
XIE Yan
HOU Yan
WANG Wei-yu
ZHU Jun
SONG Yu-qin
Abstract：Objective:Malignant tumors pose a serious threat to the health and lives of populations,thus the development of anti-tumor drugs is progressing rapidly.Establishing unified data standards is crucial for cross-indication evaluations and multi-study meta-analyses.This study is grounded in the real-world challenges of clinical research in China and proposes a unified clinical research standard data model using lymphoma as a disease model,ensuring a consistent approach in data collection,analysis,and sharing.Methods:This paper conducts an in-depth comparison of five widely used international medical data models,and systematically examines the strengths and limitations of each model.It summarizes the challenges and opportunities encountered in the application of data model standards and explores the formulation of data standards for the current lymphoma specialty field in China.Results:We have successfully established 14 data set areas and standardized descriptions for both general lymphoma data and the treatment domain.Additionally,the descriptions for six attributes of each metadata have been defined,and preliminary standard datasets for lymphoma clinical research have been developed.Conclusion:Developing clinical data standards for specialty fields helps ensure the quality benchmarks,facilitating data analysis and aggregation,and enabling comparison across multiple research studies.This supports the needs of clinical trials,scientific researches,and operational management fields for data analysis,ultimately contributing to the ecosystem development of clinical research on anti-tumor drugs in China.
Keywords：lymphomaclinical researchdata standardizationmetadata
Publication Date：2025-05-15
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：8( 953-960 )