Asian Journal Of Social Pharmacy

Abstract: Objective To introduce the concept and plan design of pragmatic clinical trials based on real-world study (RWS) so as to provide both guidance for clinical trials and reference for relevant personnel studying RWS. Methods A retrospective study was made on the design of real-world clinical trials at home and abroad in recent years to summarize their design process and applications. Results and Conclusion The advantages of combining randomization and real-world data in clinical trials are important methods for evaluating medical interventions in the real clinical environment. Practical clinical trials can evaluate the therapeutic effects of interventions in real or close to real medical environments to obtain the best real-world evidence.

Key words: RWS, pragmatic clinical trial, design