Enhancing Korean Clinical Trial Excellence:Addressing Regulatory Gaps and Implementing Competency-Based Education in a Global Context

Author: Eun-Kyeong LEE
Publication Type:Reserch Article
From: Korean Journal of Medical Ethics 2025;28(2):125-144
CountryRepublic of Korea
Language:English
Abstract: This article critically evaluates Korea's current mandatory, time-based clinical trial education system in light of the rapidly changing global clinical trial landscape and international best practices. It identifies key limitations and proposes a strategic shift towards a Competency-Based Education (CBE) model to enhance the quality, safety, and national competitiveness of clinical trials. By analyzing the new competencies required by technological innovations such as Decentralized Clinical Trials (DCTs) and Artificial Intelligence (AI), as well as the latest ICH GCP E6(R3) guideline, and by comparing Korea's system with the educational frameworks of the United States, United Kingdom, and European Union, this article diagnoses the shortcomings of the current system, including its rigidity, emphasis on compliance over competence, and misalignment with global trends. As a solution, the article explains the necessity of adopting a CBE model and offers specific policy directions based on the internationally recognized Joint Task Force (JTF) for Clinical Trial Competency framework. The proposals presented here aim to improve the quality of clinical trials in Korea, enhance participant safety, and ultimately contribute to building an ethical, efficient, and globally competitive clinical trial ecosystem.