Applied regulatory science research to evaluate and treat cardiotoxicity of oncology therapeutics

The Food and Drug Administration (FDA) is seeking applied regulatory science research to evaluate and treat cardiotoxicity of oncology therapeutics. The goal of this funding opportunity is to support research that improves the detection, monitoring, and treatment of cardiotoxicity in oncology patients. Specific areas of interest include standardizing definitions for cardiotoxicity, developing biomarkers and imaging techniques, and creating a standardized monitoring plan. The FDA anticipates substantial involvement in study design and reviewing interim deliverables to ensure that the studies develop practical approaches and solutions that have the potential to inform regulatory decision making. Key areas of focus include: • Standardizing definitions for cardiotoxicity • Developing biomarkers and imaging techniques for assessing cardiotoxicity • Creating a standardized cardiotoxicity monitoring plan • Identifying patients at higher risk for cardiotoxicity • Utilizing electronic health records to collect and store cardiotoxicity data • Integrating patient-reported outcomes related to cardiovascular health • Developing innovative approaches to treat cardiotoxicities • Investigating the natural history of cardiotoxicities