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J Korean Med Sci. 2018 Jun 26;33(34):e213. doi: 10.3346/jkms.2018.33.e213. eCollection 2018 Aug 20.

Real-world Evidence versus Randomized Controlled Trial: Clinical Research Based on Electronic Medical Records.

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Department of Medical Informatics, The Catholic University of Korea College of Medicine, Seoul, Korea.
Division of Endocrinology and Metabolism, Department of Internal Medicine, Seoul St. Mary's Hospital, The Catholic University of Korea College of Medicine, Seoul, Korea.
Division of Biomedical Informatics, Systems Biomedical Informatics Research Center, Seoul National University College of Medicine, Seoul, Korea.


Real-world evidence (RWE) and randomized control trial (RCT) data are considered mutually complementary. However, compared with RCT, the outcomes of RWE continue to be assigned lower credibility. It must be emphasized that RWE research is a real-world practice that does not need to be executed as RCT research for it to be reliable. The advantages and disadvantages of RWE must be discerned clearly, and then the proper protocol can be planned from the beginning of the research to secure as many samples as possible. Attention must be paid to privacy protection. Moreover, bias can be reduced meaningfully by reducing the number of dropouts through detailed and meticulous data quality management. RCT research, characterized as having the highest reliability, and RWE research, which reflects the actual clinical aspects, can have a mutually supplementary relationship. Indeed, once this is proven, the two could comprise the most powerful evidence-based research method in medicine.


Randomized Control Trial; Real-world Data; Real-world Evidence

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