Applied Regulatory Science Research to Evaluate Cardiotoxicity of Oncology Therapeutics (U01) Clinical Trial Optional
Funding supports research to enhance detection and monitoring of heart toxicity caused by cancer treatments through applied regulatory science.
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Funder: Food and Drug Administration (FDA)
Due Dates: August 8, 2025 (Full Application)
Funding Amounts: Up to $500,000 per year for up to 3 years; total program funding up to $1.5M; 1–3 awards expected
Summary: Supports applied regulatory science research to improve detection and monitoring of cardiotoxicity from oncology therapeutics.
Key Information: Foreign organizations and non-U.S. components are not eligible; clinical trial optional.
Description
This opportunity from the FDA Oncology Center of Excellence supports applied regulatory science research to advance the detection and monitoring of cardiotoxicity associated with oncology therapeutics. As cancer treatments evolve, there is a growing need to better understand, define, and predict cardiovascular side effects—both acute and chronic—linked to these therapies. The intent is to fund research that addresses practical gaps in regulatory science, focusing on standardized definitions, improved monitoring, biomarker development, and predictive modeling for cardiotoxicity in cancer patients. Basic science or projects focused on development of a specific therapeutic product are not eligible; the emphasis is on applied research with direct regulatory and clinical impact.
