Description

This funding opportunity from the Food and Drug Administration (FDA) aims to support applied regulatory science research focused on evaluating and treating cardiotoxicity associated with oncology therapeutics. The primary goal is to generate practical approaches and solutions that can inform future FDA regulatory decision-making. The FDA’s Oncology Center of Excellence (OCE) is particularly interested in research that advances the detection, monitoring, and treatment of cardiotoxicity in patients receiving cancer therapies.

FDA staff will have substantial involvement in the funded projects, including input on study design and review of interim deliverables. Regular calls with funded investigators will be organized to ensure research remains aligned with FDA needs and priorities.

Key areas of interest include:

• Standardizing definitions for types and grades of cardiotoxicity
• Standardizing biomarkers and imaging techniques for cardiotoxicity assessment in oncology trials
• Defining consistent criteria for evaluating cardiac function
• Developing standardized monitoring plans for cardiac assessments during trials
• Creating risk stratification models to identify high-risk patients
• Leveraging electronic health records and real-world data for systematic cardiotoxicity data collection
• Integrating patient-reported outcomes related to cardiovascular health
• Building collaborative networks to share data and best practices
• Contributing to and utilizing public cardiotoxicity databases
• Developing innovative treatments for cardiotoxicities associated with new oncology therapeutics
• Studying the natural history of cardiotoxicities with new cancer treatments