Supporting the use of Real-World Data to Generate Real-World Evidence in Regulatory Decision-Making (U01) Clinical Trials Optional

Background
The U.S. Food and Drug Administration (FDA) is exploring innovative ways to produce scientific evidence in support of regulatory submissions. This includes the development of new data sources, study designs, methodologies, and technologies. The agency encourages and facilitates the use of innovative approaches while ensuring that the scientific evidence supporting marketing approvals meets high evidentiary standards. Under the 21st Century Cures Act, FDA is exploring and implementing the use of real-world data (RWD) and real-world evidence (RWE) to support FDA's monitoring of the safety of approved drugs and the approval of new indications or post-approval study requirements for approved drugs.

Grant Details
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. The overarching goal is to address gaps in knowledge that currently limit the usefulness of RWD and RWE. The primary objectives include improving the quality and/or use of RWD, promoting better understanding of RWE study designs, and developing specific tools to evaluate aspects of RWE generation.

The scope includes:
- Designing and conducting demonstration projects
- Identifying innovative approaches to interventional studies (clinical trials) that incorporate RWD to generate RWE
- Evaluating feasibility of RWD to capture disease-progression endpoints or disease-control endpoints
- Addressing challenges involving data curation, transformation, and analysis in studies using RWD
- Demonstrating how registries can add value
- Using RWD/RWE to enhance patient diversity in clinical research
- Promoting the use of innovative technologies.

Eligibility Requirements
Eligible applicants include higher education institutions, nonprofits with 501(c)(3) IRS status, for-profit organizations (including small businesses), local governments, state governments, U.S. territories or possessions, Indian/Native American tribal governments (both federally recognized and other than federally recognized), independent school districts, public housing authorities/Indian housing authorities, Native American tribal organizations (other than federally recognized tribal governments), regional organizations, faith-based or community-based organizations. Foreign institutions are not eligible to apply.

Period of Performance
The project period is a maximum of three years with one year of initial support and potential recommended support for two additional years contingent upon annual appropriations, availability of funding, and satisfactory recipient performance.

Grant Value
FDA/CDER intends to fund up to $5.5 million for fiscal year 2023 in support of this grant program. It is anticipated that up to 2-4 awards will be made, not to exceed $2,250,000.00 million in total costs (direct plus indirect), per award.