"Already 41 Deaths This Year"... Clinical Trial Fatalities 'Surge' Over 5 Years

"Urgent Measures Needed to Ensure Participant Safety"
MFDS "Over 95% of Cases Involve Anticancer Drug Administration...
Increase in Clinical Cases and Active Reporting Should Also Be Considered"

Over the past five years, the number of cases involving hospitalization or death after participating in clinical trials has been steadily increasing.

According to data submitted by the Ministry of Food and Drug Safety to Seo Mi-hwa, a member of the National Assembly's Health and Welfare Committee from the Democratic Party of Korea, as of the end of August this year, there have been 41 deaths and 480 hospitalizations due to "Suspected Unexpected Serious Adverse Reactions (SUSAR)" during clinical trials.

The annual number of deaths and hospitalizations related to clinical trials were reported as follows: ▲2019 - 34 deaths (256 hospitalizations) ▲2020 - 33 deaths (298 hospitalizations) ▲2021 - 35 deaths (426 hospitalizations) ▲2022 - 42 deaths (466 hospitalizations) ▲2023 - 61 deaths (621 hospitalizations). Comparing the 2023 figures to those of 2019, deaths and hospitalizations have increased by approximately 80% and 143%, respectively. This year’s numbers, recorded only up to August, already exceed the annual figures from 2019 to 2021.

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 deaths from unknown causes, such as deaths at other hospitals or solitary deaths at home where family members could not be contacted, and 23 cases related to blood disorders such as neutropenia and hemorrhage.

The companies reporting the highest number of deaths due to SUSAR during this period were ▲AstraZeneca Korea, followed by ▲Roche Korea and ▲Pfizer Korea.

Assemblywoman Seo stated, "The increasing trend in deaths and hospitalizations due to adverse reactions in clinical trials is very concerning," and emphasized, "The Ministry of Food and Drug Safety, which is responsible for oversight, must implement drastic measures to ensure the safety of participants."

In response, the Ministry of Food and Drug Safety explained, "Reported SUSAR cases may result from a combination of factors, including the investigational drug, the patient’s underlying conditions, disease progression, and concomitant medications." They added, "It should be noted that the number of clinical trials itself is increasing, and over 95% of SUSAR reports occur in patients receiving anticancer drugs." Furthermore, they stated, "Globally, there is a practice of proactively reporting suspected adverse reactions even when the relationship with the investigational drug is not yet confirmed, to ensure the safety of clinical trial subjects."