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摘要： Objective To introduce the design of observational trials under real-world study (RWS), and to provide guidance for clinical development of new research trials and reference for real-world researchers. Methods Relevant literature of RWS and observational experiments at home and abroad were reviewed and analyzed, and then the design of observational studies was summarized under RWS. Results and Conclusion The data and information provided in observational studies not only help to further verify the clinical study results obtained by randomized controlled trial (RCT) in clinical practice, but also objectively reflect the real situation in the process of clinical research and application.
