[Reporter's Notebook] Is Korea really a clinical trial powerhouse?

The government aims to make Korea a top-three global clinical trial nation by 2030.

While this is ambitious, industry feedback highlights major challenges that must be addressed to achieve it.

Especially in the field of chronic diseases, concerns are emerging from various quarters that competitiveness is already weakening. While Korea superficially maintains the image of a “clinical trial powerhouse,” a structure is solidifying that pushes the country out of the competition before it even reaches the starting line in the chronic disease sector.

The industry's foremost concern is the pace of clinical trial initiation in Korea. Patient recruitment in global clinical trials is a race against time. When trials launch simultaneously across countries, competition arises over the number of patients who can be enrolled. In fields like chronic diseases, where the patient pool is large, enrollment often closes in an instant. The problem is that Korea struggles to enter this competition on time.

The procedures required to obtain Investigational New Drug (IND) approval in Korea are complex, and the submission requirements are demanding, leading to long preparation times. Subsequent review processes often involve requests for additional data, further extending timelines.

Industrialists lament this situation, saying, “While patient enrollment in other countries finishes weeks earlier, Korea repeatedly finds itself waiting for IND approval.” Ultimately, Korean institutions fail to secure opportunities to participate in global trials, and their competitiveness in chronic disease areas naturally weakens.

Conversely, in the fields of cancer and rare diseases, patient recruitment is lengthy, so the timing of initiation is less critical. This allows Korea's strengths—such as efficient patient recruitment and organizational capabilities—to drive high participation rates, establishing Korea as a clinical trial leader in these areas. However, for chronic diseases, where patient recruitment is quicker, other countries typically progress much faster, making it nearly impossible for Korea to compete on speed.

Another structural issue is the concentration of clinical trial sites.

Most trials in Korea are conducted primarily at tertiary general hospitals. However, a significant number of patients with chronic diseases receive ongoing treatment at primary care facilities. There is a lack of a structure that enables these patients to access trial information or to naturally connect with participating institutions. In global chronic disease trials where patient recruitment is rapid, this accessibility gap directly translates to a loss of competitiveness.

The industry points out that this trend could also lead to approval delays. Failure to participate in global trials reduces opportunities to utilize data during approval reviews and likely delays the domestic launch timeline. This results in patients receiving new drug treatment opportunities later than they should. Clinical trial participation competitiveness is not merely an issue of industrial efficiency; it is also intrinsically linked to patient access.

Consequently, the pharmaceutical industry has recently submitted several improvement proposals to the Ministry of Food and Drug Safety (MFDS). First, they request the establishment of standardized protocols for registering phase 1–3 clinical trials to enhance procedural standardization and predictability. Currently, the preparatory requirements for each clinical phase are not sufficiently systematized, forcing companies to spend excessive time on pre-submission verification and supplementary work.

There is also a strong demand to rationalize the requirements for submitted materials. The industry points out that unnecessary requests for supplementary information delay the review process and are a major cause of delayed clinical trial initiation. The industry is calling for clear adjustments to data submission standards within the scope of maintaining safety and quality.

Furthermore, shortening the review period is an urgent industry demand. Critics argue that review delays are a key reason Korea lags behind other nations, particularly in the treatment of chronic diseases. Without addressing this, Korea risks falling further from the center of global clinical trials.

The government's stated goal is an important signal demonstrating its commitment to fostering clinical trials as a national strategic industry. However, the most critical aspect in achieving this goal is directly addressing “current weaknesses” rather than focusing solely on “areas where Korea already excels.” Chronic disease clinical trials are the field where these weaknesses are most starkly evident. With slow procedures, limited institutional participation, and poor patient accessibility, it is difficult to gain a competitive edge globally.

For Korea to truly maintain its title as a clinical trial powerhouse and achieve its 2030 goals, efforts must be made to align regulatory speed with on-the-ground speed as much as possible. Clinical trials are not merely research procedures; they are the front lines of global new drug development. Falling behind on this front makes regaining competitiveness even harder.

What is needed now is not a “powerhouse image,” but decisive structural innovation to regain competitiveness in chronic disease clinical trials. Unless the government acts to solve this challenge, the 2030 goal will become nothing more than a numerical declaration. Korea must act immediately, embracing urgent reforms to establish itself as a genuine hub for clinical trials rather than ignoring the warning signs flashing before it.