Korea has taken its first step into the future of clinical research with the launch of a pioneering decentralized clinical trial (DCT) pilot project, marking a significant shift in the country's approach to medical research. The initiative, led by the Korea National Enterprise for Clinical Trials (KoNECT), aims to develop a uniquely Korean model for conducting remote clinical trials.
The Ministry of Health and Welfare has committed 4.5 billion won ($3.3 million) over five years to support this innovative program. Professor Kim Kyung-hwan of Seoul National University Hospital's Department of Cardiovascular and Thoracic Surgery will spearhead the research efforts across seven participating medical institutions.
Strategic Implementation and Protocol Design
The pilot program introduces a hybrid approach to clinical trials, combining traditional and remote elements. While initial patient visits will be conducted face-to-face, subsequent monitoring and care will utilize virtual platforms, including video calls and wearable devices. Healthcare providers will make home visits for essential services such as medication delivery, vital sign measurements, and blood sample collection.
"We launched the pilot project to improve the inefficiency of existing clinical trials and expand patient participation," explains Baek Sun-woo, head of the Smart Clinical Trial New Technology Development and Research Project Team at KoNECT. "Currently, it is difficult for local patients to participate in clinical trials conducted by large hospitals in Seoul. The decentralized clinical trial will help us overcome these regional limitations."
Regulatory Framework and Initial Focus
The program operates within strict regulatory boundaries, focusing initially on marketed drugs to ensure safety and compliance. The trials will target mild conditions, including depression, lung disease, obesity, and hypertension. Unlike more permissive DCT programs in countries like the United States, Korea's approach maintains tight control over drug distribution, requiring in-person delivery by medical professionals or pharmacists affiliated with trial institutions.
Addressing Challenges and Future Prospects
While some experts have criticized the project's conservative approach of using only licensed drugs, KoNECT officials defend the strategy as necessary for systematic development. "We plan to comprehensively review the accuracy of data, patient benefits, and cost-effectiveness through traditional clinical trials and comparative studies," Baek noted, emphasizing the importance of a phased approach.
Several aspects of DCTs, including recruitment, enrollment, and data collection, can be implemented immediately under current regulations. However, features such as remote electronic consent, video medical treatment, and home delivery of medicines still require regulatory adjustments.
Collaborative Framework
The initiative emerges from extensive discussions within a public-private DCT consultative body, including the Ministry of Health and Welfare, the Ministry of Food and Drug Safety (MFDS), pharmaceutical companies, medical institutions, and contract research organizations (CROs). This collaborative approach ensures comprehensive stakeholder input in developing the Korean DCT model.
The participating medical centers include Seoul National University Hospital, Gachon University Gil Medical Center, Chungbuk National University Hospital, Chungnam National University Hospital, Chonnam National University Hospital, Dongguk University Medical Center, and CHA University Bundang Medical Center, creating a robust network for trial implementation.
