No. of clinical trials rise despite COVID-19

713 trials approved last year… a 13.6% increase from the previous year

Early multinational clinical trials account for 53.5% of early clinical trials, exceeding MNCs proportion of Phase III trials for the first time

Despite the COVID-19 outbreak last year, the number of clinical trials conducted in Korea had increased, which raised Korea’s global clinical trial rank by two steps.

 

In particular, this was the first time the proportion of early clinical trials (Phase I, II) had exceeded the Phase III trials.

 

Such positive results were possible with the Ministry of Food and Drug Safety (MFDS) and clinical research institutions’ quick response to the COVID-19 variable.

 

A joint analysis by MFDS and Korea National Enterprise for Clinical Trials (KoNECT) of clinical trials aproved in 2020 showed that despite the COVID-19 crisis, the total number of trials approved last year was 799, an 11.9% point increase from the 714 in 2019.

 

The number of approve trials had increased for 3 consecutive years to reach 799 trials last year.

 

Among the trials, company-sponsored trials by pharmaceutical companies drove the growth, accounting for 611 (76.5%) trials, a 13.6% point increase from the 538 conducted in 2019.

 

Looking at the 611 company-sponsored trials by each phase, the increase was focused around early clinical trials (Phase I and II).

 

The number of Phase I and II trials among the 611 trials last year was 400, an increase from 309 in 2018 and 322 in 2019.

 

In the past, over half of the multinational clinical trials conducted in Korea used to be Phase III trials, however, for the first time last year, the number of early clinical trials (Phase I and II) exceeded the proportion of Phase III trials.

 

The proportion of Phase III trials among multinational clinical trials (355) rose from 55.7% in 2018 to 55.2% in 2019, then fell under 50% to mark 45.1% last year.

 

On the other hand, among multinational clinical trials (355), the proportion of Phase I and II trials were 43.9% in 2018 and 43.8% in 2019, which then surged in 2020 to 53.5%.

 

By efficacy, early clinical trials on anticancer drugs and infectious diseases (antibiotics etc.) had increased greatly.

 

This is in line with the global trend, where the development of anticancer drugs and COVID-19 treatments/vaccines are being actively progressed.

 

Phase I and II clinical trials for anticancer drugs had increased greatly from 81 in 2019 to 160 last year.

 

The number of Phase I and II clinical trials for infectious diseases approved last year was 42.

 

According to the clinical trial registration website developed by the National Institute of Health (NIH), the number of clinical trials increased globally last year, and Korea’s global clinical trial ranking rose two steps from the 8th in 2019 to 6th, the highest-ever rank to be recorded by Korea.

 

The analysis is that the increase of domestic clinical trials and multinational clinical trials in Korea are a result of Korea’s rapid response to the change in clinical trial environment caused by COVID-19, and the global recognition of Korea's clinical trial competency.

 

In particular, the increase of early clinical trials for anticancer treatment is expected to provide new opportunities to patients suffering from late-stage cancer, etc.

 

who have no other available treatment options.

 

“Through the operation of the ‘National infectious disease clinical trial center and the National clinical trial participant platform, we plan to establish a COVID-19 clinical trial success model and actively foster Korea's clinical trial competency." The MFDS also plans to actively support the rapid development of COVID-19 treatments and vaccines by actively resolving difficulties in clinical trial sites and operating the Institutional Review Board (IRB) while further strengthening the protection of rights and interests of clinical trial participants and reinforcing safety management of clinical trials.