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Regional Variations in Clinical Trial Outcomes in Oncology
Brooke E Wilson1,2, Sallie-Anne Pearson3,4, Michael B Barton1
1Collaboration for Cancer Outcomes, Research and Evaluation, South West Clinical School, University of New South Wales, Liverpool, New South Wales, Australia.
Journal of the National Comprehensive Cancer Network : JNCCN
|August 10, 2022
Summary
Regional differences in oncology clinical trials are increasingly observed as studies become more international. Our findings show no significant outcome differences between high-income and mixed-income regions, offering a guide for clinicians to assess true variation.
Area of Science:
- Oncology
- Clinical Trials
- Health Economics
Background:
- Regional variations in oncology clinical trial outcomes are not well-documented.
- Understanding these differences is crucial as trials become more globalized.
Purpose of the Study:
- To quantify regional variation in oncology registration studies.
- To develop a guide for clinicians to evaluate the significance of observed regional differences.
Main Methods:
- Analysis of 147 oncology registration studies (2010-2020) from FDA archives.
- Extracted data on participating countries, regional subgroup analyses, and outcomes (overall survival, progression-free survival).
- Conducted meta-analysis and pairwise comparisons between high-income and mixed-income regions.
Main Results:
- Oncology trials are increasingly multinational.
- Regional heterogeneity in overall survival and progression-free survival was observed in 17.8% and 18% of relevant studies, respectively.
- No significant difference in overall survival outcomes was found between high-income and mixed-income regions.
Conclusions:
- Increasing internationalization of oncology trials may lead to apparent regional outcome variations.
- A 5-question guide is provided to help clinicians discern clinically meaningful regional differences from statistical anomalies.
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