Korea will significantly expand eligibility for cancer drug clinical trials, allowing patients who still have other standard treatment options to participate much earlier. The Ministry of Food and Drug Safety announced on Nov. 25 that participation would no longer be limited to terminal-stage patients if trials are medically appropriate for both the patient and physician.
The policy shift is aimed at strengthening patients’ “right to life and right to choose,” and reflects the growing recognition that earlier access to innovative medicines may improve outcomes. Until now, trial participation was usually reserved for patients who had exhausted all approved therapies — a rule designed for safety but widely criticized for denying early-stage patients’ potential benefits.
The reform comes as oncology drugs advance rapidly, with newer targeted therapies, antibody–drug conjugates, and immunotherapies offering improved efficacy with fewer side effects. The calls for reform have been intensified by patient advocacy groups and clinicians, who argue that the “late-stage only” model lags behind scientific progress and other international markets.
To support implementation, the MFDS will issue a new guidance in December, titled “Considerations for Selecting Participants in Early-Stage Cancer Clinical Trials.” Officials also expect the change to help drug development by allowing earlier, richer data collection that could accelerate approvals for breakthrough treatments.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.