Guideline Analysis and Discussion on the Design and Statistical Methods for Real-World Study of Medical Devices
In recent years,real-world study(RWS)of medical devices have attracted significant attention.Many regulatory agencies around the world have formulated and issued relevant guidelines,but none have included specific content related to RWS design,statistical analysis,and reporting.In January 2024,the Center for Medical Device Evaluation of the National Medical Products Administration released the Guidance on Real-World Study Design and Statistical Analysis for Medical Device Registration Review,which is the first guideline in the world specifically targeting the design and statistical analysis of RWS for medical devices.This guidance provides a comprehensive framework for RWS design and analysis,focusing on its core characteristics,with detailed analysis and discussion on key aspects such as study design essentials,data quality control,bias control,statistical analysis methods,and study reporting requirements It helps to improve research quality and standardize and reasonably guide the application of RWS in the clinical evaluation of medical devices.It is worth noting that RWS still faces significant challenges,such as the lack of high-quality real-world data(RWD),the complexity of study design,and difficulties in controlling bias.In the future,with the accumulation of relevant experience and the refinement of regulatory framework,RWS is likely to play a more significant role in the clinical evaluation of medical devices.
medical devicesreal-world studystatistical analysisstudy designbias and quality control
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