Discussion on the Application of Real-world Study for Clinical Evaluation of Medical Devices
Objective:To explore how real-world study(RWS)generate real-world evidence to support regulatory decisions for the marketing of medical devices based on ethical and regulatory compliance.Methods:Based on the relevant policies,guiding principles,and research status of RWS in clinical research of medical devices both domestically and internationally,the requirements of RWS in clinical evaluation of medical devices were analyzed from the aspects of key points of research scheme design,real-world data quality control,data statistical analysis and case analysis.Results and Conclusion:RWS provides strong support for the marketing of medical devices due to its relaxed patient enrollment criteria,broad population coverage,and large sample size.The scientific and logical design of clinical trial program,the traceability and quality control throughout the implementation process,as well as the appropriate use of statistical analysis methods are the key for transforming real-world data into real-world evidence.Promoting the application of RWS in medical device clinical trials will facilitate the marketing of medical devices and promote the healthy and rapid development of the entire medical device industry.
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