Publications by authors named "Hui-Eon Lee"
Article Synopsis
- Europe, the U.S., and Korea each have systems to track rare adverse events from drugs after they are marketed, with Korea focusing on a re-examination system and risk management plan to monitor safety.
- This study compares post-marketing safety issues related to the drug dapagliflozin as identified by the European Medicines Agency (EMA), the U.S. FDA, and the Korean Ministry of Food and Drug Safety.
- There is a 71% agreement between safety issues found by the EMA/FDA and those noted in Korea, but Korea's system struggles with long-term outcome tracking and needs better regulations and guidelines for ongoing safety assessments.
Background: The effectiveness of COVID-19 vaccines is generally reduced in cancer patients compared to the general population. However, there are only a few studies that compare the relative risk of breakthrough infections and severe COVID-19 outcomes in fully vaccinated cancer patients versus their unvaccinated counterparts.
Methods: To assess the effectiveness of COVID-19 vaccines in cancer patients, we employed (1) a self-controlled risk interval (SCRI) design, and (2) a retrospective matched cohort design.