Korea ranked fifth in the “national share” of the worldwide clinical trial registration numbers, breaking the previous record.
The Ministry of Food and Drug Safety and the Korea National Enterprise for Clinical Trials (KoNECT) announced the “Approval of clinical trials for pharmaceutical products in 2022” report on Friday.
According to the report, Korea ranked fifth in national share in 2022, up one notch from sixth place in 2020 and 2021.
In “clinical trials by city,” Seoul topped the list, and Korea ranked third in the “clinical trials by a single country,” maintaining previous places.
However, in the "multinational clinical trial" category, Korea ranked 11th, down one notch from the previous year, as European countries stepped up efforts in this area. Still, Korea’s 11th place was the highest among Asian nations.
The ministry cited as significant characteristics of the domestic clinical trials in 2022 the return to pre-Covid-19 levels in the number of approved clinical trials, the increase in the share of pharmaceutical company-led clinical trials, and the maintenance of previous year’s level in clinical trials that used clinical trial products developed by the domestic pharma companies.
The number of approved clinical trials dropped 15.6 percent to 711 in keeping with the global downturn in clinical trials, returning to the pre-Covid-19 level of 2019.
The number of “pharmaceutical company-initiated clinical trials” totaled 595, accounting for 83.7 percent of the total, up 3.1 percentage points from 80.6 percent in 2021. “Investigator-initiated clinical trials” totaled 116 in number last year, showing declines in both the number and their share from 163 in 2021.
Clinical trials that used medical products developed by foreign pharma companies fell 15.1 percent, and those using medical products developed by domestic companies also slid 8.5 percent over the period.
The government will do its best to help the domestic clinical trials lead international standards by continually improving systems to protect the safety and rights and interests of clinical trial participants through strengthening safety information management of clinical trial medical products, and preemptive responding to rapid change in clinical trial environments, such as non-face-to-face clinical trials and developing new-technology medical products,” a ministry official said.