Discussion and Work Experience Sharing of Real-World Data Quality Control in the Clinical Comprehen-sive Evaluation of Drugs
OBJECTIVE To explore the quality control of real-world data in the drug clinical comprehensive evaluation,and pro-mote the scientific and rational application of real-world data in the drug comprehensive clinical evaluation.METHODS Literature on the quality control of real-world research data in drug clinical comprehensive evaluation was reviewed,and the work experience of the drug clinical comprehensive evaluation center in the province where the author is located was integrated to explore the content and process of quality control of real-world research data in drug clinical comprehensive evaluation.RESULTS AND CONCLUSION Quality control of real-world research data generally includes internal and external controls.Evaluation methods comprise qualitative assessment,quanti-tative assessment,and comprehensive assessment.The implementation phase can be divided into the project initiation phase and the data governance phase,with a round of data quality control conducted in each phase.This study summarizes the content and process of quality control for real-world research data in the drug clinical comprehensive evaluation,providing a reference for researchers and decision-mak-ers to correctly produce and use evidence from real-world data for drug clinical comprehensive evaluation.
drug clinical comprehensive evaluationreal-world dataquality control
万方数据
维普
