Expert Interviews
Clinical Research in South Korea: Challenges, Opportunities, and the Expertise of Soyoun Jung
Soyoun (Soyeon) Jung, a Clinical Project Manager and Senior CRA hybrid, has extensive experience managing Phase III trials, including Tau aggregation inhibitors and 5-HT6 receptor antagonists for Alzheimer’s disease, as well as PCSK9 inhibitors for familial hypercholesterolemia. Her expertise in South Korea’s regulatory landscape and managing feeder-to-extension studies highlights her skills in ensuring compliance, trial continuity, and patient safety.
Soyoun’s insights offer a valuable glimpse into the challenges and advancements shaping clinical research today, particularly in the South Korean context.
• What motivated you to pursue a career in clinical research, and what were some of the initial challenges you faced when starting as a CRA in South Korea?
Soyoun (Soyeon) Jung: My primary motivation was knowing that my work directly impacts study quality and the development of new drugs for patients who lack standard treatment options. The initial challenge I faced was managing a heavy workload, as there were numerous tasks to handle simultaneously when I first started.
•What recommendations would you give to those who wish to start a career as a CRA, and what do you think is the future of this profession in South Korea?
Most colleagues have experienced health issues related to a heavy workload, so health management is crucial for CRAs.
-I believe the demand for CRAs will continue, as South Korea is a good country to conduct clinical trials based on the following conditions.
► Medical infrastructure concentrated in Seoul and Gyeonggi province
► Population density (51 million, with 18 % concentrated in Seoul and 45% in Seoul + Gyeonggi province near Seoul)
► Patient crowding due to the social phenomenon of people going to Big 4 hospitals in Seoul when they are sick.
► Easy access to medical care due to National Health Insurance, many patients undergoing treatment without financial burden. Clinical trials can be chosen as one of the treatment options.
► 208 MFDS-approved Clinical Trial Sites in S. Korea (as of Aug2023) which conduct trials and maintain adherence due to a high degree of professionalism and a culture of deep respect between patients and physicians.
► The country’s patient recruitment, retention, and compliance rates are higher than in most Western countries and are comparable with other emerging Asian countries.
► South Korea has one of the shortest startup times in Asia.
• Could you share an example of a clinical project you've worked on that had a significant impact on your professional development or on healthcare in South Korea?
Soyoun (Soyeon) Jung: Phase I for solid tumors harboring the mutations in the MAPK pathway.
My main task was country/site setup, and I could provide valuable insights into the big picture of timelines and detailed activities covering SSU, PV and RA for the study team without the local support team based on my previous experience as a multiplayer. This experience helped me grow professionally as I was able to leverage all of my past experiences to successfully manage the entire process.
• What differences and similarities do you see in clinical research processes in South Korea compared to other countries, and how do these affect clinical trial management?
Soyoun (Soyeon) Jung: The clinical research process in South Korea is similar to those of other countries. However, there are some local regulatory nuances and time management considerations that can affect the pace and execution of trials. The clinical research process in South Korea involves several critical milestones that require careful planning and coordination to ensure timely trial initiation. Key steps include regulatory submissions to MFDS, IRB approvals at individual sites, and the completion of contractual agreements. Additionally, obtaining an import license for investigational products and site readiness for the Site Initiation Visit (SIV) are essential. The timeline reflects dependencies between these steps, with parallel processes, such as IRB review and contract negotiations, helping to streamline progress. By adhering to this structured approach, trials can achieve site activation efficiently, maintaining compliance with local regulatory requirements.
Thank you, Soyoun, for sharing your valuable insights and expertise. Your experience in managing Phase III trials and your deep understanding of South Korea’s regulatory landscape are truly inspiring. We appreciate your time and look forward to following your contributions to clinical research. Thank you again for being part of our interview series.