关键词: 真实世界研究; 方案设计；设计要点；统计分析

Abstract: National regulatory authorities and experts have published a series of guidelines and studies on real-world data and real-world evidence, but there is still no clear document guidance on the detailed protocol and statistical analysis methodology of real-world research. We comprehensively reviewed various documents and studies related to real-world data, based on the experience of research protocol design, and developed the research design key points and statistical analysis based on real-world data. The protocol of real-world research needs to explain the applicability of real-world data, comprehensively explain data governance methods from the aspects of data source, data relevance, data integrity, data accuracy and data extraction methods, and evaluate data quality. Statistical analysis methods are used to analyze the reliability and robustness of real-world research conclusions, thus to produce high-quality real-world evidence.

Key words: Real-world study; Protocol design; Key point of design; Statistical analysis