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.
J Korean Med Sci. 2018 Jun 26;33(34):e213. doi: 10.3346/jkms.2018.33.e213. eCollection 2018 Aug 20.
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.
真实世界证据（RWE）和随机对照试验（RCT）数据被认为是相互补充的。然而，与 RCT 相比，RWE 的结果仍然被赋予较低的可信度。必须强调的是，RWE 研究是一种真实世界的实践，不需要像 RCT 研究那样执行，它才是可靠的。必须清楚地辨别 RWE 的优缺点，然后从研究开始就制定适当的方案，以确保尽可能多的样本。必须注意隐私保护。此外，通过详细和细致的数据质量管理，减少大量的脱落，可显著减少偏差。RCT 研究具有最高的可靠性，而反映实际临床方面的 RWE 研究，可以具有相互补充的关系。事实上，一旦证明了这一点，两者就可以构成医学中最强大的基于证据的研究方法。
