Applied regulatory science research to evaluate and treat cardiotoxicity of oncology therapeutics
Forecasted Federal grant Posted
- Opportunity number
- FOR-FD-25-015
- Agency
-
Food and Drug Administration
Department of Health and Human Services
- Applications expected due
- Not on record
- Award size
- Not on record
Opportunity facts
- Assistance listings
- Funding instrument
- Cooperative Agreement
- Categories
-
- Agriculture
- Consumer Protection
- Food and Nutrition
- Eligible applicants
-
- State Governments
- Public or Indian Housing Auth.
- Tribal Governments (Federally Recognized)
- For Profit Organizations
- County Governments
- City/Township Governments
- Tribal Organizations (Not Federally Recognized)
- Unrestricted
- Non-501(c)(3) Nonprofits
- 501(c)(3) Nonprofits
- Independent School Districts
- Small Businesses
- Special District Governments
- Higher Education Inst. (Public)
- Higher Education Inst. (Private)
- Points of contact
-
- Terrin Brown terrin.brown@fda.hhs.gov (240) 402-7610
Opportunity details come from Grants.gov. Updated .
About this opportunity
The Food and Drug Administration is soliciting applications for cooperative agreements to support applied regulatory science research evaluating and treating cardiotoxicity of oncology therapeutics, under CFDA 93.103 Food and Drug Administration Research. This is a forecast opportunity with no application deadline specified in the source.
Eligible applicants include state governments, county and city governments, tribal governments and organizations (both federally recognized and non-federally recognized), special district governments, public and private higher education institutions, independent school districts, for-profit organizations, small businesses, non-501(c)(3) nonprofits, 501(c)(3) nonprofits, and public or Indian housing authorities. No cost share requirement is stated.
The FDA anticipates substantial involvement in study design and interim deliverable review to ensure research develops practical regulatory approaches. Regular collaboration calls with funded investigators will supplement annual reporting. Research areas of interest include standardized cardiotoxicity definitions and grading, biomarker and imaging standardization, consistent cardiac function evaluation criteria, formalized monitoring plans specifying assessment timing, risk stratification models for high-risk patients, electronic health record data collection and standardization, integration of patient-reported cardiovascular outcomes, and collaborative networks with research institutions and industry partners for data and best-practice sharing.
Primary deliverables are publications and presentations that inform FDA regulatory decision-making. Award ceiling, award floor, expected number of awards, period of performance, and place of performance are not specified in the source.
Forecast synopsis
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.
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