Active Domestic New Drug Research in 'Researcher Clinical' in the First Half of the Year... 'Big 5' Concentration Remains

In the first half of this year, the number of investigator-initiated clinical trials approved by the Ministry of Food and Drug Safety slightly decreased compared to previous years. While research on domestic new drugs is actively being conducted, the proportion of investigator-initiated clinical trials at large hospitals, known as the so-called 'Big 5,' remains significant.

[Image source=Pixabay]

On the 3rd, the Ministry of Food and Drug Safety's 'Drug Safety Korea' registered a total of 56 investigator-initiated clinical trial approvals from January to June this year. This is somewhat lower compared to 79 cases in 2021 and 59 cases last year during the same period. Unlike clinical trials conducted by pharmaceutical companies, investigator-initiated clinical trials are conducted based on the judgment of researchers to verify unproven drugs or to confirm new efficacies and effects of existing drugs. These trials are increasingly important as they can provide new treatment opportunities for patients and serve as a starting point for new drug development.

Among the approved investigator-initiated clinical trials, research to explore new possibilities for domestic new drugs such as Yuhan Corporation's non-small cell lung cancer treatment drug 'Reclaza' and Daewoong Pharmaceutical's potassium-competitive acid blocker (P-CAB) class gastroesophageal reflux disease new drug 'Pexuclu' was active. For Reclaza, recently approved as a first-line treatment for non-small cell lung cancer, investigator-initiated clinical trials were approved to evaluate monotherapy or combination therapy with cytotoxic anticancer drugs in patients positive for circulating tumor DNA (ctDNA) after first-line monotherapy, as well as to confirm the appropriateness of a starting dose of 160 mg per day.

Yuhan Corporation's non-small cell lung cancer new drug 'Reclaza' (above) and Daewoong Pharmaceutical's gastroesophageal reflux disease new drug 'Pexuclu' [Photo by each company]

Pexuclu received investigator-initiated clinical trial approvals at several medical institutions. In the first half of the year, five such trials were approved, three of which aimed to confirm the efficacy and safety of Pexuclu in Helicobacter pylori eradication therapy. Additionally, clinical trials were approved to evaluate the efficacy and safety of preventing gastritis symptoms in patients using systemic steroids and to compare the treatment effects of Pexuclu with proton pump inhibitors (PPIs), which are commonly prescribed for peptic ulcer treatment.

Investigator-initiated clinical trials are clearly distinct from pharmaceutical company-led trials conducted solely for new drug development. Since clinical medical staff independently conduct the research, more independent studies are possible, and these trials provide opportunities to discover new treatments in relatively less focused areas such as rare and intractable diseases. A pharmaceutical industry official explained, "Through investigator-initiated clinical trials conducted directly by medical staff, it is possible to identify other efficacies of drugs that pharmaceutical companies may have overlooked. Since these trials are conducted by clinicians seeking the best treatment for patients, if they are actively carried out, they could become a new starting point for drug development."

Seoul Asan Medical Center exterior. [Photo by Seoul Asan Medical Center]

However, the reality is that investigator-initiated clinical trials in South Korea are still concentrated in some large hospitals in Seoul. In the first half of this year, the so-called 'Big 5' (Seoul Asan Medical Center, Severance Hospital, Samsung Medical Center, Seoul National University Hospital, and Seoul St. Mary's Hospital) accounted for more than half, 53.5% (30 cases), of investigator-initiated clinical trials. By hospital, Seoul Asan Medical Center had the most with 10 cases, followed by Seoul National University Hospital with 7, Severance Hospital with 6, Samsung Medical Center with 5, and Seoul St. Mary's Hospital with 2. Outside of the Big 5, the only hospital that received approval for two or more investigator-initiated clinical trials was the National Cancer Center.

Especially among local university hospitals outside the metropolitan area, investigator-initiated clinical trial approvals amounted to only 8 cases (14.3%). For investigator-initiated clinical trials to be more actively conducted at a wider variety of medical institutions, the range of opportunities for patient treatment and new drug development can be expanded. A university hospital official said, "This phenomenon occurs because there are relatively more hospitals located in the metropolitan area, and there are differences in infrastructure such as research personnel, research funding, and clinical patients. To further activate investigator-initiated clinical trials, policy support such as research funding and expanded insurance coverage for clinical trial patients will be necessary."

This content was produced with the assistance of AI translation services.