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Enhancing Clinical Cancer Research Through Sharing of Data and Biospecimens
Hans Wildiers1, Virginie Adam2, Seamus O'Reilly3
1Department of General Medical Oncology, University Hospitals Leuven, Leuven, Belgium.
JAMA Oncology
|December 18, 2025
Summary
Sharing clinical trial data and biospecimens is crucial for personalized cancer therapy. Current sharing practices are suboptimal, necessitating strategies like academic-patient co-leadership and data access for future research to improve patient care.
Area of Science:
- Oncology
- Translational Research
- Biomarker Discovery
Background:
- Molecular analyses of biospecimens are key for identifying biomarkers to tailor cancer treatments.
- Sharing clinical trial data and biospecimens accelerates personalized medicine and new treatment development.
Purpose of the Study:
- To identify obstacles to data and biospecimen sharing in clinical trials.
- To propose strategies for enhancing access and collaboration in biomarker research.
Main Methods:
- Review of 29 breast cancer registrational clinical trials (2017-2024) approved by regulatory bodies.
- Analysis of biomarker research publication rates and impact on drug indications.
- Expert opinion from 53 academic investigators and patient representatives.
Main Results:
- Biomarker research from registrational trials rarely restricted drug indications.
- Published biomarker studies from these trials are infrequent, despite participant biospecimen contributions.
- None of the 29 breast cancer trials resulted in biomarker research that restricted a drug's approved indication.
Conclusions:
- Data and biospecimen sharing from registrational trials has been suboptimal.
- Enhanced sharing requires a multi-stakeholder approach involving academia, patients, and industry.
- Proposed strategies include co-leadership, explicit consent for data sharing, and access to biospecimens for independent research.
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