Gachon University Gil Medical Center

South Korea Launches First Decentralized Clinical Trial Program with $3.3M Investment

4 months ago

Korea National Enterprise for Clinical Trials (KoNECT) has initiated the country's first decentralized clinical trial (DCT) pilot project, backed by a 4.5 billion won ($3.3 million) government investment over five years. The program, involving seven major medical institutions, will initially focus on approved drugs for mild conditions, allowing patients to participate in trials from home while maintaining regulatory compliance.

Korean Dementia Association Addresses Leqembi Safety Concerns, Cites Lower Side Effect Incidence in East Asians

7 months ago

• The Korean Dementia Association addressed concerns over Leqembi's safety, emphasizing that side effects like brain hemorrhage and edema are rare, particularly in East Asians. • Phase 3 trial data involving Korean participants showed a lower incidence of amyloid-related imaging abnormality-edema (ARIA-E) at 5.6%, compared to 12.6% overall. • Leqembi, co-developed by Eisai and Biogen, received approval in South Korea for treating mild cognitive impairment and early-stage Alzheimer's disease, despite EU and Australian rejections. • Experts highlight the need for insurance coverage and increased domestic experience with Leqembi to ensure its effective and smooth introduction in Korea.