Korea at a crossroads in clinical trials as China soars to dominance

Asia is slowly gaining ground in clinical trials, but it's nothing compared to China's explosive rise. From a mere 3 percent of global trials in 2013, China's dominance surged to an astonishing 28 percent by 2023, while Europe saw a decline, industry data showed. 

Despite its vast population offering a high patient availability score, China's clinical infrastructure struggles to keep pace with demand, revealing a system straining under the weight of its own ambitions. Japan, too, faces its own challenges, bogged down by strict domestic regulations that exclude many global studies from entering its borders.

Korea, however, is at a tipping point. With a fourth-place global ranking and a rapidly evolving infrastructure, Rhee Hyun-joo, head of site management at IQVIA Korea, stated at this year’s KoNECT-MOHW (Ministry of Health and Welfare) International Conference on Wednesday that the country “could emerge as the most capable nation in Asia for attracting a larger number of clinical trials, positioning itself favorably in the global clinical trial landscape."

Then came the dagger. 

While Korea aligns well on transparency, speed, and simplicity in terms of regulation, Rhee noted a sticking point: flexibility. “Korea still exhibits a notable reluctance to embrace innovative trial designs,” Rhee said. “This is the view from a global perspective."

A total of 244 trials were approved for domestic companies from January to September this year, a 15.1 percent increase, while 276 were approved for multinational firms, marking a 3.89 percent year-on-year increase. Despite a steady increase in clinical trials, Rhee noted that Korea struggles when it comes to advancing trial techniques.

Regulatory challenges and logistical issues with hospital system access slow progress, particularly for domestic pharmaceutical and biotechnology companies, which often focus on early-phase trials due to limited resources. Many seek licensing deals with global firms, supported by the KDDF (Korea Drug Development Fund), yet shrinking global investments make these partnerships tougher to secure. 

Current trends focus on oncology and metabolic diseases, with almost all trials from Chinese firms in Korea centered on ADCs (antibody-drug candidates), making up over 95 percent of their studies. 

The MFDS (Ministry of Food and Drug Safety) fast approval process has catapulted Korea to fourth in global trial rankings, yet a “prevailing mindset limits clinical studies to MFDS-approved drugs,” said Professor Im Seock-ah of Seoul National University’s Cancer Research Institute. 

Over the past five years, more multi-country trial protocols have excluded Korean participants, limiting local researchers’ scope and leading some global companies to withdraw from phase 1 trials, citing patient safety and procedural challenges.

Meanwhile, China’s rapid advancements in ADCs have seen many drugs move to phase 3 there before expanding globally, stoking concerns that Korea could be left behind.

Although Korea possesses top-tier research institutions and skilled researchers, Kim Yeul-hong, R&D president at Yuhan Corp., emphasized the importance of considering target markets and patient demographics in trial planning. These factors, he notes, “ultimately determine the focus of these trials.” 

And while Korea has built a strong reputation for managing emergency care and executing trials with precision, as the year unfolds, Professor Im voiced concern, saying she has “begun to feel somewhat skeptical about how long we can maintain this excellence,” as regulatory limitations restrict Korea from participating in numerous studies, including feasibility trials.

Park In-sook, director at the Korea Regulatory Science Center, added that Korea’s pharmaceutical and biotech industries are evolving through AI, digital transformation, and innovative trial designs, stressing the urgency for efficiency in drug development. Key trends include decentralized trials, wearable tech, and real-world data integration.

“The MFDS is exploring decentralized trials, but Korea’s designated clinical trial institution model may restrict growth compared to countries like the U.S.,” Park said. Despite these hurdles, she emphasized that the shift toward decentralization is “unavoidable,” and discussions are ongoing about how to overcome regulatory barriers. 

The MFDS is currently developing guidelines to support advanced technology use for recruiting participants and managing trial data, aiming to sustain trial quality while evolving alongside global standards.