Renewal Application: Increasing the Quality and Efficiency of Clinical Trials (U18) Clinical Trials Optional
ID: 353917Type: Posted
Overview

Buyer

Food and Drug Administration (HHS-FDA)

Award Range

$0 - $8M

Eligible Applicants

Others

Funding Category

Food and Nutrition

Funding Instrument

Cooperative Agreement

Opportunity Category

Discretionary

Cost Sharing or Matching Requirement

Yes
Timeline
    Description

    The Food and Drug Administration (FDA) is offering a cooperative agreement opportunity to support the Clinical Trials Transformation Initiative (CTTI) through a single-source application from Duke University’s Clinical Research Institute (DCRI). The objective of this funding is to enhance the quality and efficiency of clinical trials by addressing existing inefficiencies and promoting best practices within the clinical research community. This initiative is crucial for advancing regulatory processes and improving public health outcomes, with a funding ceiling of $7.5 million available for a five-year project period starting in September 2024, contingent on FDA appropriations. Applications are due by July 3, 2024, and interested parties can contact Terrin Brown at terrin.brown@fda.hhs.gov for further information.

    Point(s) of Contact
    Files
    Title
    Posted
    The FDA, through its Center for Drug Evaluation and Research (CDER), is offering a cooperative agreement opportunity for Duke University’s Clinical Research Institute (DCRI) to support the Clinical Trials Transformation Initiative (CTTI). This initiative aims to enhance the quality and efficiency of clinical trials by addressing inefficiencies and promoting best practices. A single source application is requested, with funding available up to $7.5 million for a five-year project period, starting in September 2024 and contingent on FDA appropriations. Key activities include developing infrastructure for CTTI projects, managing resources, and fostering collaboration among diverse stakeholders in clinical research. Significant past projects have included enhancing enrollment of underrepresented populations in clinical trials and establishing metrics to assess progress in transforming trials by 2030. Applications are due by July 3, 2024, with review scheduled for August 2024. This funding aims to advance regulatory processes, ultimately benefiting public health and improving clinical trial systems.
    Similar Opportunities
    Collaborations to Enhance Drug Development and Regulatory Science
    Active
    Food and Drug Administration
    The Food and Drug Administration (FDA) is inviting applications for a federal grant titled "Collaborations to Enhance Drug Development and Regulatory Science." This opportunity aims to establish cooperative agreements that support Public-Private Partnerships and collaborative activities under the Critical Path Initiative, focusing on innovative projects that enhance drug product development, advanced manufacturing, and the translation of scientific discoveries into therapeutics. The initiative is crucial for fostering innovation in drug safety, efficacy, quality, and performance, with a total funding ceiling of $5 million available for six expected awards in fiscal year 2024. Interested applicants can reach out to Terrin Brown at terrin.brown@fda.hhs.gov or call (240) 402-7610 for further information.
    Cooperative Agreement to Support Effective Dissemination of Clinical Practice Guidelines
    Active
    Food and Drug Administration
    The Food and Drug Administration (FDA) is forecasting a cooperative agreement opportunity titled "Cooperative Agreement to Support Effective Dissemination of Clinical Practice Guidelines." This initiative aims to support the dissemination of clinical practice guidelines, particularly those developed with prior FDA cooperative agreements, by requiring applicants to propose a comprehensive plan for developing, evaluating, and distributing materials that facilitate this dissemination, with a strong emphasis on equity. The funding for this opportunity has an award ceiling and floor of $1,000,000, with one award expected to be made in fiscal year 2025. Interested applicants can reach out to Terrin Brown at terrin.brown@fda.hhs.gov or call 240-402-7610 for further details.
    Drug Development Tools Research Grants (U01) Clinical Trials Optional
    Active
    Food and Drug Administration
    The Food and Drug Administration (FDA) is offering Drug Development Tools Research Grants (U01) to support research aimed at advancing drug development tools (DDTs) that have an accepted or reviewable Letter of Intent within the FDA's qualification program. These grants are intended for developers working towards their qualification plan or full qualification package, focusing on tools that can enhance public health by optimizing the drug development process, such as biomarkers or animal models. The funding opportunity provides up to $500,000 for a maximum two-year period, with applications due by May 13, 2024, and May 13, 2025. Interested applicants can reach out to Terrin Brown at terrin.brown@fda.hhs.gov for further information and are encouraged to review the detailed announcement available at https://grants.nih.gov/grants/guide/rfa-files/RFA-FD-24-030.html.
    Center for Research on Complex Generics (U18) Clinical Trials Optional
    Active
    Food and Drug Administration
    The Food and Drug Administration (FDA) is forecasting a funding opportunity for the establishment of a Center for Research on Complex Generics through a cooperative agreement. This initiative aims to enhance collaboration with the generic drug industry, focusing on identifying scientific challenges in generic product development and facilitating research that supports the FDA's mission to improve patient access to high-quality, safe, and effective generic drugs. The Center will serve as a hub for coordination among FDA, academia, and industry stakeholders, conducting research, hosting workshops, and providing public access to research outcomes. Interested applicants can reach out to Terrin Brown at terrin.brown@fda.hhs.gov or by phone at 240-402-7610. The funding amount is set at $1.5 million, with one award anticipated for the fiscal year 2025.
    FDA OMHHE Health Equity Innovation Award: Enhance Equity Funding Opportunity (U01) Clinical Trials Not Allowed
    Active
    Food and Drug Administration
    The Food and Drug Administration (FDA) is forecasting a funding opportunity titled "FDA OMHHE Health Equity Innovation Award: Enhance Equity Funding Opportunity (U01)," aimed at advancing minority health and health equity objectives. This cooperative agreement seeks innovative research proposals that enhance diversity in clinical trials, improve data availability on diverse populations, and amplify diverse patient perspectives and needs. The initiative is crucial for addressing disparities in health outcomes and ensuring equitable representation in health research. Interested applicants can apply for a funding amount of $1 million, with an expected four awards to be made, and should direct inquiries to Terrin Brown at terrin.brown@fda.hhs.gov or call 240-402-7610. The opportunity is set for the fiscal year 2025 and was last updated on August 14, 2024.
    FDA OMHHE Health Equity Innovation Award: Enhance Equity Funding Opportunity (U01) Clinical Trials Not Allowed
    Active
    Food and Drug Administration
    The Food and Drug Administration (FDA) is offering the Health Equity Innovation Award (U01) to fund innovative research aimed at enhancing minority health and advancing health equity objectives. This funding opportunity focuses on proposals that promote diversity in clinical trials, improve data availability on diverse populations, and amplify the voices of underrepresented patient groups. With an award ceiling of $1 million and a floor of $250,000, the FDA anticipates making four awards in fiscal year 2024. Interested applicants can reach out to Terrin Brown at terrin.brown@fda.hhs.gov or call 240-402-7610 for further information.
    Clinical Trials Addressing Unmet Needs of Rare Neurodegenerative Diseases (R01) Clinical Trials Required
    Active
    Food and Drug Administration
    The Food and Drug Administration (FDA) is forecasting a federal grant opportunity titled "Clinical Trials Addressing Unmet Needs of Rare Neurodegenerative Diseases (R01) Clinical Trials Required." This grant aims to fund clinical trials that evaluate the efficacy and safety of products intended to address unmet needs in rare neurodegenerative diseases affecting both children and adults, thereby increasing the number of approved treatments in this critical area. The initiative is part of the FDA's broader effort to enhance drug development for rare diseases, which is vital for improving health outcomes in affected populations. Interested applicants can reach out to Terrin Brown at terrin.brown@fda.hhs.gov or call 240-402-7610 for more information, with funding amounts ranging from $650,000 to $900,000 for the fiscal year 2025.
    Flexible Funding Model-Infrastructure Development and Maintenance for State Manufactured Food Regulatory Programs (U2F) Clinical Trials Not Allowed
    Active
    Food and Drug Administration
    The Food and Drug Administration (FDA) is forecasting a funding opportunity titled "Flexible Funding Model-Infrastructure Development and Maintenance for State Manufactured Food Regulatory Programs (U2F)," aimed at enhancing state manufactured food regulatory programs. This cooperative agreement seeks to support the development and maintenance of Manufactured Food Regulatory Program Standards (MFRPS) to ensure high-quality regulatory frameworks that improve food safety and reduce foodborne illness hazards. Eligible applicants include state, tribal, and territorial food safety programs with existing FDA food safety inspection contracts or those willing to enter into such contracts, with funding amounts ranging from $340,000 to $1,285,000 per year. Interested parties can contact Terrin Brown at terrin.brown@fda.hhs.gov or (240) 402-7610 for further information, with applications expected to align with the fiscal year 2024 timeline.
    Cooperative Agreement to Support Activities Related to Analgesics, Anesthetics, and Addiction (U01) Clinical Trials Allowed
    Active
    Food and Drug Administration
    The Food and Drug Administration (FDA) is forecasting a cooperative agreement opportunity titled "Cooperative Agreement to Support Activities Related to Analgesics, Anesthetics, and Addiction (U01)," aimed at advancing research in Anesthesia, Addiction Medicine, and Pain Medicine. Applicants are required to propose comprehensive, evidence-based plans that focus on critical areas such as clinical trial endpoints for chronic pain, outcome measures for stimulant use disorders, and assessments of opioid clinical trials, among others. This initiative is vital for enhancing the understanding and management of analgesics and anesthetics, particularly in vulnerable populations. The FDA anticipates awarding five grants, each with a funding ceiling and floor of $2 million, with applications due for the fiscal year 2025. Interested parties can reach out to Terrin Brown at terrin.brown@fda.hhs.gov or call 240-402-7610 for further information.
    Improving Predictability of Food-Drug and Drug-Drug Interaction Risks by Utilizing In Vitro Simulated Gastrointestinal Dissolution Model for High-Risk Oral Drug Products (U01) Clinical Trial Optional
    Active
    Food and Drug Administration
    The Food and Drug Administration (FDA) is offering a funding opportunity titled "Improving Predictability of Food-Drug and Drug-Drug Interaction Risks by Utilizing In Vitro Simulated Gastrointestinal Dissolution Model for High-Risk Oral Drug Products (U01) Clinical Trial Optional." This initiative aims to develop and validate an in vitro mechanistic methodology to assess the performance of amorphous solid dispersion (ASD) drug products under various clinically relevant conditions, ultimately enhancing the understanding of how food and acid-reducing agents affect drug absorption. The funding, which ranges from $250,000 to $500,000, is intended to support research that correlates in vitro observations with in vivo outcomes, thereby informing regulatory decisions for high-risk generic oral drug products. Interested applicants can reach out to Terrin Brown at terrin.brown@fda.hhs.gov or call (240) 402-7610 for further information, with applications being accepted for the fiscal year 2024.