A recent incident involving a woman in her 20s who suffered a stroke following a clinical trial has stirred controversy about who should be held accountable for adverse events during such trials. (Image courtesy of Yonhap News TV)
SEOUL, Oct. 9 (Korea Bizwire) – The number of deaths and hospitalizations resulting from unexpected serious adverse reactions during clinical trials in South Korea has increased significantly over the past five years, according to data released by the country’s Ministry of Food and Drug Safety.
Representative Seo Mi-hwa of the Democratic Party, a member of the National Assembly’s Health and Welfare Committee, revealed that 41 deaths and 480 hospitalizations due to Suspected Unexpected Serious Adverse Reactions (SUSARs) were reported in clinical trials through August of this year.
The annual figures show a concerning upward trend. In 2019, there were 34 deaths and 256 hospitalizations. These numbers steadily increased each year, reaching 61 deaths and 621 hospitalizations in 2023. Compared to 2019, the number of deaths in 2023 increased by approximately 80%, while hospitalizations surged by 143%.
Among the 246 reported deaths over the past five years, pneumonia was the most common adverse reaction, accounting for 100 cases. This was followed by 27 cases of unexplained deaths, including instances where patients died at other hospitals or at home and family members couldn’t be contacted. Blood-related deaths, such as neutropenia and hemorrhage, accounted for 23 cases.
AstraZeneca Korea reported the highest number of SUSAR-related deaths during this period, followed by Roche Korea and Pfizer Korea.
Seo expressed deep concern over the rising numbers, stating, “The Ministry of Food and Drug Safety, which is responsible for oversight, must implement extraordinary measures to ensure the safety of participants.”
In response, the Ministry of Food and Drug Safety emphasized that SUSARs can result from various factors, including patients’ underlying conditions, disease progression, and concomitant medications, not just the trial drugs themselves.
A ministry official noted that the increase in reports should be considered in the context of a growing number of clinical trials, with over 95% of SUSAR reports occurring in cancer patient groups receiving chemotherapy.
M. H. Lee (mhlee@koreabizwire.com)
