Search
- Page Path
- HOME > Search
Special Article
- Pragmatic Clinical Trials for Real-World Evidence: Concept and Implementation
- Na-Young Jeong, Seon-Ha Kim, Eunsun Lim, Nam-Kyong Choi
- Cardiovasc Prev Pharmacother. 2020;2(3):85-98. Published online July 31, 2020
- DOI: https://doi.org/10.36011/cpp.2020.2.e12
- 14,710 View
- 237 Download
- 3 Citations
-
Abstract
PDF - The importance of real-world evidence (RWE) has been highlighted in recent years, and the limitations of the classical randomized controlled trials, also known as explanatory clinical trials (ECTs), have been emphasized. Post-marketing observational studies have several problems, such as biases and incomparability between patient groups, and RWE 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 short time. PCTs are clinical trials that have a pragmatic concept, i.e., the opposite of ECTs and are intended to help decision makers by evaluating the effectiveness of interventions in routine clinical practice. The characteristics of PCTs are the inclusion of various patients in clinical practice, recruitment of patients in heterogeneous settings, and comparison with actual clinical treatments rather than a placebo. Thus, the results of PCTs are likely to be generalized and can have a direct impact on clinical and policy decision-making. This study aimed to describe the characteristics and definitions of PCTs compared with those of ECTs and to highlight the important considerations in the planning process of PCTs. To perform PCTs for the purpose of obtaining RWE, the contents covered in this study will be helpful.
-
Citations
Citations to this article as recorded by
- Reconciling Methodological Paradigms Toward More Accurate Evaluation of Personalized Traditional Chinese Medicine (TCM) Intervention in Standardized Trials: Introducing the TRIPLE-TCM Trial Framework
Fei-Yi Zhao, Li-Ping Yue, Peijie Xu, Russell Conduit, Wen-Jing Zhang, Yuan Xin Lee, Qiang-Qiang Fu, Chin Moi Chow
Therapeutics and Clinical Risk Management.2025; Volume 21: 1521. CrossRef - Enhancing Safety in Clinical Practice: Cross-Sectional, Within-Subjects, Simulated-Use Compliance Study Using BD PosiFlush SafeScrub
Kyle De Boer, John Simpson, Purnima Sharma, Trevor J Steele
JMIR Human Factors.2025; 12: e78967. CrossRef - A scoping review of the Choice and Partnership Approach in child and adolescent mental health services
Kathleen Pajer, Carlos Pastrana, William Gardner, Aditi Sivakumar, Ann York
Journal of Child Health Care.2023; 27(4): 707. CrossRef
- Reconciling Methodological Paradigms Toward More Accurate Evaluation of Personalized Traditional Chinese Medicine (TCM) Intervention in Standardized Trials: Introducing the TRIPLE-TCM Trial Framework
First
Prev
