The purpose of this Funding Opportunity Announcement (FOA) is to address topics related to FDA’s Real-World Evidence (RWE) Program and to enable FDA to assess the potential utility of real-world data (RWD) in generating RWE.
Donor Name: Food and Drug Administration
State: All States
County: All Counties
Territory: American Samoa, Commonwealth of Puerto Rico, Commonwealth of the Northern Mariana Islands, Guam, and U.S. Virgin Islands
Type of Grant: Grant
Deadline: 02/28/2023
Size of the Grant: $6,750,000
Grant Duration: 3 years
Details:
The Food and Drug Administration (FDA) protects the public health by ensuring that medical products intended to be marketed in the United States are safe and effective for their intended use. FDA stakeholders are exploring innovative ways to produce scientific evidence in support of regulatory submissions, including the development of new data sources, study designs, methodologies, and technologies. FDA encourages and facilitates the use of such innovative approaches while ensuring that the scientific evidence supporting marketing approvals meet our high evidentiary standards.
The overarching goal of this Funding Opportunity Announcement (FOA) is to address gaps in knowledge that currently limit the usefulness of RWD and RWE. The primary objectives of this announcement are to a) improve the quality and/or use of RWD, b) promote better understanding of RWE study designs, and c) develop specific tools to evaluate aspects of RWE generation. The scope includes, but is not limited to, projects that focus on:
- Designing and conducting demonstration projects that promote clarity and better understanding of key components of studies utilizing RWD
- Identifying innovative approaches to interventional studies (clinical trials) that incorporate RWD to generate RWE
- Identifying innovative approaches to non-interventional (observational) studies that incorporate RWD to generate RWE
- Evaluating feasibility of RWD to capture disease-progression endpoints or disease-control endpoints, especially for therapeutic areas for which RWD has not been used extensively
- Addressing challenges involving data curation, transformation, and analysis in studies using RWD
- Demonstrating how registries can add value, including linking of registries to other RWD sources
- Using RWD/RWE to enhance patient diversity in clinical research, including for historically under-represented populations
- Promoting the use of innovative technologies, such as digital health tools, predictive algorithms, and sensors.
- A variety of project types are welcomed under this FOA, applicable to drugs and biologics (not devices).
Funding Information
- Award Ceiling: $6,750,000
- Award Floor: $1,000,000
- The maximum project period is THREE (3) years.
Eligibility Criteria
- Higher Education Institutions
- Public/State Controlled Institutions of Higher Education
- Private Institutions of Higher Education
- The following types of Higher Education Institutions are always encouraged to apply for FDA support as Public or 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)
- 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.
For more information, visit Grants.gov.
