South Korea Advised to Improve Environment for Clinical Trials

The Korea Research-based Pharmaceutical Industry Association (KRPIA) has advised the South Korean government to improve the environment for clinicial trials of new cancer and rare disease treatments.

The association announced on Sept. 19 that global pharmaceutical companies' clinical trials in Korea of new cancer and rare disease drugs decreased in 2018, although their overall R&D investment in Korea increased.

According to the association, its 31 members invested a total of 470.6 billion won in clinical R&D activities in 2018. When it comes to the 28 members that participated in its survey in 2016, 2017 and 2018, spending on clinical R&D rose from 400 billion won in 2017 to 464.1 billion won in 2018.

The R&D work force of the 31 members totaled 1,717 researchers in 2018. That of the 28 companies amounted to 1,678 researchers, up 8.2 pecent from 2017.

Likewise, their direct spending on drugs freely provided to patients participating in clinical trials increased 19.3 percent to 154 billion won last year.

Cancer drugs and rare disease treatments accounted for 49 percent (583 cases) and 5 percent (63 cases) of their clinical trials, respectively.

Still, the numbers of their cancer- and rare disease-related clinical trials in South Korea showed a significant decrease in 2018. Specifically, the former fell 4.27 percent from 609 to 583 and the latter dropped 42.86 percent from 98 to 56.

The KRPIA said that the South Korean government needs to expand systematic support for clinical trials of new cancer drugs and rare disease medicines in light of the drop in Korea's access to new cancer and rare disease treatments in recent years. 

The KRPIA also said that South Korea represented 3.39 percent, sixth-highest in the world, of global pharmaceutical companies’ clinical trial protocols in 2018 whereas the ratio was 3.51 percent, fifth-highest, in the previous year. On the other hand, China’s ratio jumped from 3.7 percent (fifth-highest) to 4.66 percent (third-highest) during the period through deregulation for drug approval facilitation.