Applied regulatory science research to evaluate and treat cardiotoxicity of oncology therapeutics
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The Food and Drug Administration is seeking to fund applied regulatory science research focused on evaluating and treating cardiotoxicity caused by oncology therapeutics, with the aim of generating practical, regulatory-relevant outcomes that can inform future decision-making. The initiative emphasizes deep collaboration with FDA staff, who will actively participate in study design and review interim deliverables, expecting more frequent engagement than annual reporting alone can provide, including regular calls with funded investigators to ensure research aligns with regulatory priorities. Key research priorities include standardizing definitions and grading of cardiotoxicity, validating and harmonizing biomarkers and imaging techniques for use in oncology trials, establishing consistent criteria for cardiac function assessment, and developing standardized monitoring plans that define when cardiac evaluations should occur during treatment. Additional goals involve creating risk stratification models based on patient history and therapy profiles, leveraging electronic health records and real-world data to improve data quality and completeness, and incorporating patient-reported outcomes on cardiovascular symptoms and quality of life. The program also encourages participation in collaborative networks with academic and industry partners, contributions to public cardiotoxicity databases, research on the natural history of these toxicities, and the development of novel therapeutic approaches to mitigate or treat cardiotoxicity resulting from cancer treatments.
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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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