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Regional disparities in the availability of cancer clinical trials in Korea
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Jieun Jang, Wonyoung Choi, Sung Hoon Sim, Sokbom Kang
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Epidemiol Health. 2024;46:e2024006. Published online December 11, 2023
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DOI: https://doi.org/10.4178/epih.e2024006
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 Abstract
Summary
 PDF Supplementary Material
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Abstract
OBJECTIVES
Unequal access to cancer clinical trials is an important issue, given the potential benefits of participation for cancer patients. We evaluated regional disparities in access to cancer clinical trials in Korea.
METHODS From the Ministry of Food and Drug Safety database, we extracted 2,465 records of all cancer clinical trials approved between January 2012 and April 2023. To measure disparities in cancer clinical trial access, we calculated the ratio of clinical trials open to non-capital areas relative to those open to capital areas. We then analyzed temporal trends in this ratio, which we termed the trial geographical equity index (TGEI).
RESULTS Disparities in access to cancer clinical trials, as indicated by the TGEI, did not significantly improve during the study period (regression coefficient, 0.002; p=0.59). However, for phase II/III trials sponsored by global pharmaceutical companies, the TGEI improved significantly (regression coefficient, 0.021; p<0.01). In contrast, the TGEI deteriorated for trials initiated by investigators or those testing domestically developed therapeutics (regression coefficient, -0.015; p=0.05). Furthermore, the increasing trend of TGEI for phase II/III trials sponsored by global companies began to reverse after 2019, coinciding with the outbreak of coronavirus disease 2019 (COVID-19).
CONCLUSIONS Over the past decade, access to cancer clinical trials has improved in Korea, particularly for phase II/III trials evaluating therapeutics from global companies. However, this increase in accessibility has not extended to trials initiated by investigators or those assessing domestically developed therapeutics. Additionally, the impact of COVID-19 on disparities in clinical trial access should be closely monitored.
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Summary
Korean summary
본 연구는 개시된 암 임상시험 수가 국내 수도권에 비해 비수도권에서 절대적으로 부족하고, 이러한 부족이 지난 10년간 개선되지 않았음을 보여줍니다. 다만, 글로벌 제약회사의 치료제를 검증하는 2상/3상 암 임상시험의 경우 임상시험 접근성에 대한 이러한 지역적 격차가 의미 있게 감소했으나 이러한 개선 또한 2019년 이후로는 정체되었을 수 있습니다. 상기 결과들은 임상시험 가용성의 형평성을 향상시키기 위해서는 국내 임상시험 개시 규모가 지역적 불균형을 이루고 있음에 대한 인식이 높아져야 하고, 비수도권 지역에서 임상시험 개시를 방해하는 장벽을 식별하는 데 추가적인 노력이 필요함을 강조합니다.
Key Message
The findings in this study indicate scarcity of cancer clinical trials in non-capital areas compared to that in capital areas of Korea, which has not improved over the past decade. However, this regional disparity in the access to clinical trials meaningfully decreased for phase II/III trials testing therapeutics from global pharmaceutical companies, though this progress may have stalled after 2019. This study highlights that increasing awareness of the regional imbalance in clinical trial access is vital and further efforts are needed to identify the barriers impeding the initiation of clinical trials in non-capital areas to improve the equity of availability.
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