Respiratory, cardiovascular clinical trials surged in 2021: data

Clinical trials of respiratory and cardiovascular diseases expanded rapidly in Korea in 2021, government data showed.

According to the “2021 pharmaceutical clinical trial approval status” announced by the Korea National Enterprise for Clinical Trials (KoNECT) and the Ministry of Food and Drug Safety, the number of trials led by pharmaceutical companies increased, multinational trials also expanded, and respiratory and cardiovascular trials particularly surged in Korea last year.

Clinical trials of respiratory and cardiovascular diseases increased rapidly in Korea in 2021, government data showed.

In 2021, the government approved 842 clinical trials, up 5.4 percent from 799 in the previous year. The number of clinical trials steadily increased from 714 in 2019, 799 in 2020, and 842 in 2021.

Of the 842 trials, 679 (80.6 percent) were led by drugmakers and the proportion increased by 11.1 percent from 611 in 2020.

In contrast, the number of investigator-initiated clinical trials for academic purposes without external sponsors went down to 165 in 2021, falling by 25 compared to the previous year.

It is also notable that the number of multinational clinical trials has expanded.

Among 679 trials led by pharmaceutical firms, 412 (60.7 percent) were multinational in 2021, up 16.1 percent from 355 in 2020.

Compared to trials in 2020, those in phase 1 were almost the same, phase 2 trials increased 31.3 percent, and phase 3 trials increased 12.5 percent in 2021.

The proportion of phase 1 and phase 2 studies recorded 53.4 percent, and that of phase 3 studies, 43.7 percent, in 2021, showing a similar trend compared to 2020.

However, among 412 multinational trials, only 27 (6.6 percent) were led by Korean pharmaceutical firms.

By efficacy, the government approved 36 respiratory trials and 90 cardiovascular studies in 2021, which surged by 111.8 percent and 50 percent, respectively, from 2020. Those two recorded the steepest growths in the number of trials by efficacy last year.

Worldwide, the number of clinical trials led by pharmaceutical companies also increased by 13.3 percent compared to 2020, showing that clinical trials are active in Korea and around the world.

The number of trials registered at ClinicalTrials.gov, run by the U.S. National Institutes of Health, has gone up steadily from 8,196 in 2019 to 9,713 in 2020 and 11,008 in 2021.