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Original Article
Regional disparities in the availability of cancer clinical trials in Korea
Jieun Jang, Wonyoung Choi, Sung Hoon Sim, Sokbom Kang
Epidemiol Health. 2024;46:e2024006.   Published online December 11, 2023
DOI: https://doi.org/10.4178/epih.e2024006
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AbstractAbstract AbstractSummary PDFSupplementary Material
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.
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.
Review
Applied mediation analyses: a review and tutorial
Theis Lange, Kim Wadt Hansen, Rikke Sørensen, Søren Galatius
Epidemiol Health. 2017;39:e2017035.   Published online August 6, 2017
DOI: https://doi.org/10.4178/epih.e2017035
  • 26,972 View
  • 1,041 Download
  • 88 Web of Science
  • 89 Crossref
AbstractAbstract PDF
Abstract
In recent years, mediation analysis has emerged as a powerful tool to disentangle causal pathways from an exposure/treatment to clinically relevant outcomes. Mediation analysis has been applied in scientific fields as diverse as labour market relations and randomized clinical trials of heart disease treatments. In parallel to these applications, the underlying mathematical theory and computer tools have been refined. This combined review and tutorial will introduce the reader to modern mediation analysis including: the mathematical framework; required assumptions; and software implementation in the R package medflex. All results are illustrated using a recent study on the causal pathways stemming from the early invasive treatment of acute coronary syndrome, for which the rich Danish population registers allow us to follow patients’ medication use and more after being discharged from hospital.
Summary

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Methods
An overview of systematic reviews of diagnostic tests accuracy
Jong-Myon Bae
Epidemiol Health. 2014;36:e2014016.   Published online August 29, 2014
DOI: https://doi.org/10.4178/epih/e2014016
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AbstractAbstract AbstractSummary PDFSupplementary Material
Abstract
The Cochrane Collaboration says that the Cochrane handbook for diagnostic test accuracy reviews (DTAR) is currently in development as per the Cochrane Collaboration. This implies that the methodology of systematic reviews (SR) of diagnostic test accuracy is still a matter of debate. At this point, comparison of methodologies for SR in case of interventions as against diagnostics would be helpful to understand DTAR.
Summary
Korean summary
코크란연합은 진단검사의 정확도 평가를 위한 방법론을 현재 개발 중이라고 한다. 이는 해당 방법론 개발에 있어 적극적인 이해가 있어야 한다는 뜻이다. 진단검사의 정확도 평가를 위한 체계적 고찰 수행에 관한 내용을 보다 쉽게 이해하기 위하여, 이미 정립되어 적극 활용되고 있는 개입효과 평가를 위한 체계적 고찰의 수행 과정별로 비교하여 살펴보았다.

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