Cardiovasc Prev Pharmacother. 2020 Jul;2(3):85-98 Cardiovascular Prevention https://doi.org/10.36011/cpp.2020.2.e12 eISSN 2671-700X and Pharmacotherapy Special Article Pragmatic Clinical Trials for Real-World Evidence: Concept and Implementation Na-Young Jeong , BS, Seon-Ha Kim , BS, Eunsun Lim , BS, Nam-Kyong Choi , PhD Department of Health Convergence, Ewha Womans University, Seoul, Korea Received: Jun 30, 2020 ABSTRACT Accepted: Jul 28, 2020 Correspondence to The importance of real-world evidence (RWE) has been highlighted in recent years, and Nam-Kyong Choi, PhD the limitations of the classical randomized controlled trials, also known as explanatory Department of Health Convergence, Ewha clinical trials (ECTs), have been emphasized. Post-marketing observational studies have Womans University, 52 Ewhayeodae-gil, several problems, such as biases and incomparability between patient groups, and RWE Seodaemun-gu, Seoul 03760, Korea. E-mail:
[email protected] can only be obtained after a certain period. Therefore, pragmatic clinical trials (PCTs) have garnered attention as an alternative to obtaining scientifically robust RWE in a relatively Copyright © 2020. Korean Society of short time. PCTs are clinical trials that have a pragmatic concept, i.e., the opposite of ECTs Cardiovascular Disease Prevention; Korean and are intended to help decision makers by evaluating the effectiveness of interventions in Society of Cardiovascular Pharmacotherapy. routine clinical practice. The characteristics of PCTs are the inclusion of various patients in This is an Open Access article distributed under the terms of the Creative Commons clinical practice, recruitment of patients in heterogeneous settings, and comparison with Attribution Non-Commercial License (https:// actual clinical treatments rather than a placebo.