The South Korean government’s ambition to become a top three global clinical trial hub by 2030 is reshaping how the country approaches decentralised clinical trials, according to insights shared by Heewon Lee, Manager and Clinical Research Lead at Eli Lilly, during her presentation on the first day of Outsourcing in Clinical Trials (OCT) and Clinical Trial Supply (CTS) Korea 2025.
Speaking shortly after the Ministry of Health and Welfare and Seoul National University Hospital launched a national decentralised clinical trial (DCT) pilot, she described a system rapidly redefining patient accessibility, regulatory flexibility and digital infrastructure.
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The South Korean government-backed pilot links data from multiple centres and is part of a broader national vision to build a hospital-wide exchange system with assurances of stability, integrity and compliance. South Korea’s regulators are increasingly focused on enabling community-based trial environments, allowing local centres, with prior approval by MFDS, to participate more easily. This shift, she said, reflects both national ambition and competitive pressures as South Korea seeks to strengthen its position among the world’s leading pharmaceutical R&D countries.
According to the speaker’s presentation, Eli Lilly’s own approach in Korea mirrors this national trajectory. The company’s expanding pipeline and accelerated launch trajectory has heightened the importance of trial speed, but Lee noted that speed alone is meaningless without broader patient access.
Shift to community-based research models
Rather than asking patients to travel to clinical trial sites, the community-based research (CBR) model takes research into underserved areas through mobile units, local screening sites, and partnerships with community organisations.
Digital referral systems are also becoming central to this strategy. As per Lee, Lilly now uses specialised vendors to conduct preliminary eligibility checks based on real-world data, to ensure efficient referrals on ongoing studies. The company recently launched its Lilly Trials platform, allowing patients to register their interest and consent online, complete digital pre-screening and match themselves to relevant studies. It is currently live in the US and is expected to expand globally.
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By GlobalDataWhile these innovations expand reach, Lee acknowledged that structural constraints remain. Under current South Korean regulations, only MFDS-designated clinical trial sites may conduct studies, limiting access for patients treated in primary care settings, she said. Some conditions are mostly treated at tertiary hospitals, such as oncology, while others rely heavily on primary clinics, which face their own accessibility challenges, she added. The government has announced steps toward expanding accessibility, for studies with prior MFDS approval, but progress will require continued alignment between policymakers and industry, said Lee.
South Korea ranks among the global leaders in operational performance, but its future potential depends on how effectively it can broaden access and modernise infrastructure, Lee noted. Community-based research, digital referral ecosystems and regulatory flexibility will be essential to bridging the gap. Lee ended her presentation highlighting that the goal is not the technology itself but patient accessibility.
