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

TLDR

Real‑world evidence (RWE) and randomized controlled trials (RCTs) are complementary, with RCTs offering the highest reliability and RWE reflecting actual clinical practice, together forming a powerful evidence‑based research approach. The study aims to clarify RWE’s strengths and weaknesses to design protocols that maximize sample size from the outset. The study emphasizes privacy protection and rigorous data quality management to minimize dropouts and bias. Despite RWE’s complementary role, its outcomes are still viewed as less credible than RCT results.

Abstract

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.