Last Year, 799 Clinical Trial Approvals, 12% Increase YoY... Global Ranking 6th 'All-Time High'

[Asia Economy Reporter Seo So-jeong] The number of clinical trials approved last year amid the COVID-19 crisis increased by 11.9% to 799 compared to the previous year. Additionally, South Korea's global ranking in clinical trials reached 6th place, marking the highest rank ever.

The Ministry of Food and Drug Safety (Commissioner Kim Gang-lip) and the National Clinical Trial Support Foundation (Chairman Bae Byung-jun) jointly analyzed the status of clinical trial approvals last year and announced on the 16th that the total number of approvals was 799, an 11.9% increase from 714 in 2019.

The total number of clinical trials has steadily increased over the past three years: 679 in 2018, 714 in 2019, and 799 last year.

In particular, last year saw a surge in early-stage clinical trials led by pharmaceutical companies, as well as an increase in clinical trials for infectious disease treatments such as anticancer drugs and antibiotics.

Among these, pharmaceutical company-led clinical trials accounted for 611 cases (76.5%), a 13.6% increase from 538 in 2019, driving the overall growth in clinical trials.

Breaking down the 611 pharmaceutical company-led clinical trials by phase, the increase was centered on early stages (Phase 1 and Phase 2): 309 in 2018, 322 in 2019, and 400 in 2020.

While multinational clinical trials have traditionally been dominated by Phase 3 trials, last year marked the first time that early-stage clinical trials outnumbered Phase 3 trials.

By efficacy, early-stage clinical trials for anticancer drugs and infectious disease treatments increased significantly. Anticancer drug clinical trials rose from 109 in 2018 to 160 in 2020, and infectious disease treatment clinical trials increased from 23 to 42 during the same period.

Global clinical trials also increased last year, and South Korea's global ranking in clinical trials rose two places from 8th in 2019 to 6th, achieving the highest rank ever.

The Ministry of Food and Drug Safety stated, "The increase in domestic clinical trials and the advancement of multinational clinical trials reflect South Korea's rapid response to changes in the clinical trial environment caused by COVID-19, and the country's clinical trial capabilities are being recognized worldwide. Moving forward, we plan to strengthen the protection of clinical trial participants' rights and safety management, resolve difficulties faced in clinical trial sites, and support the rapid development of COVID-19 therapeutics and vaccines through the operation of the Central Institutional Review Board (IRB)."