The goal of this funding opportunity announcement is to support applied regulatory science research to evaluate and treat cardiotoxicity of oncology therapeutics. The main outcomes of this work will be publications and presentations; however, FDA staff anticipate 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 in the future. We anticipate organizing regular calls with funded investigators to support the collaboration with FDA - reviewing annual reports would be insufficient to ensure that direction of the research addresses FDA's needs.
OCE is interested in supporting research that improve the detection, monitoring and treatment of cardiotoxicity of oncology therapeutics.
Specific areas of interest include:
-Standardize Definitions: Develop clear definitions for different types and grades of cardiotoxicity
-Biomarkers and Imaging: Standardize the use of biomarkers and imaging techniques for assessing cardiotoxicity in oncology trials
-Functional Measures: Define consistent criteria for evaluating cardiac function
-Monitoring Plan: Develop a standardized cardiotoxicity monitoring plan that specifies the timing of cardiac assessments during the trial.
-Risk Stratification: Use a risk stratification model to identify patients at higher risk for cardiotoxicity based on pre-existing conditions and treatment regimens.
-Electronic Health Records and Real-World Data: Utilize electronic health records to standardize and systematically collect and store cardiotoxicity data, ensuring data accuracy and completeness.
-Patient-Reported Outcomes: Integrate patient-reported outcomes related to cardiovascular health (e.g., symptoms of heart failure, quality of life).
-Collaborative Networks: Engage in collaborative networks with other research institutions and industry partners to share data, best practices, and insights.
-Public Databases: Contribute to and utilize public databases of cardiotoxicity data to enhance the generalizability of findings and support broader research efforts.
-Treatment: Develop innovative approaches to treat cardiotoxicities with new oncology therapeutics.
-Natural history: Studies to investigate the natural history of various cardiotoxicities with new oncology therapeutics.