NOFO: Applied Regulatory Science Research to evaluate Cardiotoxicity of Oncology Therapeutics Clinical Trial Optional (US)

NOFO: Applied Regulatory Science Research to evaluate Cardiotoxicity of Oncology Therapeutics Clinical Trial Optional (US)

Section

Deadline Date
August 8, 2025
Donor Agency
Food and Drug Administration
Grant Size
$100,000 to $500,000

This Notice of Funding Opportunity (NOFO) support applied regulatory science research to improve the detection and monitoring of cardiotoxicity of oncology therapeutics.

Goals
  • This funding opportunity seeks to advance applied regulatory science research aimed at improving the detection and monitoring of cardiotoxicity associated with oncology therapeutics. These goals align with the FDA Oncology Center of Excellence’s (OCE) mission to promote the development of safe and effective cancer treatments while addressing the significant toxicities including cardiovascular risks posed by cancer therapies.
Specific Areas
  • Specific areas of interest include proposals focused on developing promising methods and approaches to characterization and monitoring of cardiotoxicity:
    • Standardized Definitions: One of the key challenges in studying and managing cardiotoxicity is the lack of standardized definitions for different types and severities of cardiotoxicity. Research is needed to create clear, evidence-based definitions that can be universally applied across studies, cancer subtypes, and clinical settings.
      • Types of Cardiotoxicities: Cardiotoxicity can present in different forms, such as myocardial dysfunction, arrhythmias, or pericardial disease.
      • Grading of Cardiotoxicity: Standardizing the grading system based on clinical outcomes, symptoms, and diagnostic criteria (e.g., heart failure, left ventricular ejection fraction).
    • Biomarkers and Imaging: Research focused on standardizing and optimizing the use of biomarkers and imaging modalities for assessing clinically relevant cardiac toxicities.
    • Functional Measures: Research is needed to define standard and reliable criteria for evaluating cardiac dysfunction.
    • Monitoring Plan: Develop a standardized cardiotoxicity monitoring plan that specifies the timing of cardiac assessments.
      • Early detection: Developing methods to detect cardiotoxicity at an early stage, before significant damage occurs, to prevent irreversible cardiovascular damage.
      • Long-term monitoring: Creating strategies for long-term monitoring of patients who have been exposed to cardiotoxic treatments, helping detect delayed or late-onset cardiotoxicity.
      • Predictive models: Research to create models or algorithms that can predict which patients are most likely to experience cardiotoxic effects, based on genetic, clinical, or treatment-related factors.
Funding Information
  • Award Ceiling: $500,000
Eligibility Criteria
  • Eligible Organizations
    • Higher Education Institutions
      • Public/State Controlled Institutions of Higher Education
      • Private Institutions of Higher Education
    • Nonprofits Other Than Institutions of Higher Education
      • Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
      • Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)
    • For-Profit Organizations
      • Small Businesses
      • For-Profit Organizations (Other than Small Businesses)
    • Local Governments
      • State Governments
      • County Governments
      • City or Township Governments
      • Special District Governments
      • Indian/Native American Tribal Governments (Federally Recognized)
      • Indian/Native American Tribal Governments (Other than Federally Recognized)
    • Federal Governments
      • Eligible Agencies of the Federal Government
      • U.S. Territory or Possession
    • Other
      • Independent School Districts
      • Public Housing Authorities/Indian Housing Authorities
      • Native American Tribal Organizations (other than federally recognized tribal governments)
      • Faith-based or Community-based Organizations
      • Regional Organizations
    • Foreign Organizations
      • Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply.
      • Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

For more information, visit Grants.gov.

https://www.grants.gov/search-results-detail/360123

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