ESMO Congress 2023 | OncologyPRO

Abstract 1714P

Background

Ensuring equal opportunity to participate in clinical trials is important. We analyzed the effectiveness of efforts to ensure geographically equal access to cancer clinical trials in Korea.

Methods

Clinical trials registered between 2012 and 2023 in Korea were captured from the Ministry of Food and Drug Safety database. To measure geographic disparity, we calculated the ratio of clinical trials conducted in local areas compared to those conducted in metropolitan areas and called it the trial geographical disparity index (TGDI). Regression analysis was used to analyze the annual trend of the TGDI.

Results

From 191 hospitals, 9424 cancer clinical trials were identified. The mean TGDI was 46%, indicating that cancer patients living in local areas can only access 46% of cancer clinical trials available to patients living in metropolitan areas. The disparities did not increase or decrease over 12 years. The situation varies among cancer sites, however. There was an improvement in the geographical disparity in lung cancer (p = 0.019), whereas a deterioration existed in pancreatic and prostate cancer (p = 0.035 and 0.016, respectively). Additionally, TGDI has worsened in clinical trials for domestically developed drugs (R-squared 0.58). In contrast, it has significantly improved for trials initiated by global pharmaceutical companies (R-squared 0.61), especially in lung and breast cancer (p = 0.016 and 0.005).

Conclusions

Although geographical disparities in access to cancer clinical trials seem to have been fixed in Korea, our data suggest that sponsor-initiated phase II/III trials conducted by global pharmaceutical companies may have a significant role in lowering the geographical barrier and ensuring equal access.