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Real-World Accelerator to evolve the standard of Care and Engagement in clinical studies (RACE)

Award Number: U01FD007779
ORGANIZATION: FOOD AND DRUG ADMINISTRATION
OPDIV: FDA
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/01/2022
PERIOD OF PERFORMANCE END DATE: 12/31/2024

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Real-World Accelerator to evolve the standard of Care and Engagement in clinical studies (RACE) - Incomplete and inconsistent capture of race and ethnicity data from real-world data (RWD) limits the full description of the distribution, safety, and effectiveness of FDA regulated products in the population. The issues involved with acquisition and treatment of race and ethnicity data touch many domains (e.g. health disparities, health IT, workforce training, standards and policy development) and require diverse viewpoints to share knowledge and perspectives to drive solutions. Moreover, leadership from both government and the private sector are essential to muster organizational commitment and prioritize resources to implement solutions to this multi-factorial puzzle. The status quo has been to think about the problem and solutions in silos and through a narrow lens. Our goal is to increase diversity in pre- and post-market studies (including those conducted via RWD). Our objective is to understand, align, and disseminate best practices to improve real-world reporting, collection, capture, protection, aggregation, integration, and interpretation of race and ethnicity data. RACE will bring together leadership from broad sectors in a series of roundtables to advance solutions to enhance the acquisition and treatment of race and ethnicity data from real-world settings for research purposes (Aim 1). Additionally, we will conduct a landscape assessment of best practices and a public poll to assess patients’ reactions to questions of race and ethnicity to inform the roundtable series. We will summarize best practices and crowd-source the most viable solutions; amplifying the findings in public- facing multi-media to reach broad audiences and stimulate further conversation and action. The significance of Aim 1 is in the opportunity for collective learning and community capacity building. In Aim 2, we will evaluate the impact of RACE to initiate a change in practice using a pre-post, qualitative design. Interviews in ~ 30 people will be recorded, transcribed, and coded; using a template analysis approach to analyze the data and develop domain-level memos to facilitate qualitative assignment of strength and valence for each domain. We will also create stakeholder-level memos to assess change on the group level. The significance of demonstrating that bringing leaders together in a dynamic forum motivates individual change is that this model may be applied to address additional questions. In Aim 3, we will map the most salient solutions to the barriers they address. We will provide the summary of the barrier-solution to RACE participants and request feedback on the perceived effort and value of implementing the proposed solutions. This summary output will serve as a novel, multi-dimensional tool to develop strategies for implementing perceived high-value solutions; the significance of which is in providing stakeholders with a tool to prioritize and implement solutions to improve the quality of race and ethnicity data in their own environment. In short, this work will advance the discussion about the collection and use of race/ethnicity data toward action by building community capacity among leadership and collaboratively developing tools to change practice.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2025 ( Subtotal = -$10,696 )
2025	2022	REAGAN-UDALL FOUNDATION FOR THE FOOD AND DRUG ADMINISTRATION, INC.	1333 NEW HAMPSHIRE AVE NW STE 420	WASHINGTON	DC	20036	DISTRICT OF COLUMBIA	USA	Food and Drug Administration Research	000	1	7/8/2025	NEW	-$10,696
														Subtotal = -$10,696

Issue Date FY: 2024 ( Subtotal = $0 )
2024	2022	REAGAN UDALL FOUNDATION FOR THE FDA, INC.	1333 NEW HAMPSHIRE AVE., NW	WASHINGTON	DC	20036	DISTRICT OF COLUMBIA	USA	Food and Drug Administration Research	000	1	1/4/2024	NEW	$0
2024	2022	REAGAN-UDALL FOUNDATION FOR THE FOOD AND DRUG ADMINISTRATION, INC.	1333 NEW HAMPSHIRE AVE NW STE 420	WASHINGTON	DC	20036	DISTRICT OF COLUMBIA	USA	Food and Drug Administration Research	001	1	8/13/2024	NEW	$0
														Subtotal = $0

Issue Date FY: 2023 ( Subtotal = $375,000 )
2023	2023	REAGAN UDALL FOUNDATION FOR THE FDA, INC.	1333 NEW HAMPSHIRE AVE., NW	WASHINGTON	DC	20036	DISTRICT OF COLUMBIA	USA	Food and Drug Administration Research	001	1	8/15/2023	SUPPLEMENT FOR EXPANSION	$0
2023	2023	REAGAN UDALL FOUNDATION FOR THE FDA, INC.	1333 NEW HAMPSHIRE AVE., NW	WASHINGTON	DC	20036	DISTRICT OF COLUMBIA	USA	Food and Drug Administration Research	000	1	8/1/2023	SUPPLEMENT FOR EXPANSION	$375,000
2023	2023	REAGAN UDALL FOUNDATION FOR THE FDA, INC.	1333 NEW HAMPSHIRE AVE., NW	WASHINGTON	DC	20036	DISTRICT OF COLUMBIA	USA	Food and Drug Administration Research	002	1	8/22/2023	SUPPLEMENT FOR EXPANSION	$0
														Subtotal = $375,000

Issue Date FY: 2022 ( Subtotal = $499,514 )
2022	2022	REAGAN-UDALL FOUNDATION FOR THE FOOD AND DRUG ADMINISTRATION, INC.	1900 L ST NW STE 835	WASHINGTON	DC	20036	DISTRICT OF COLUMBIA	USA	Food and Drug Administration Research	000	1	8/16/2022	NEW	$499,514
														Subtotal = $499,514

Grand Total All Awards = $863,818

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Real-World Accelerator to evolve the standard of Care and Engagement in clinical studies (RACE)

Award Number: U01FD007779

ORGANIZATION: FOOD AND DRUG ADMINISTRATION

OPDIV: FDA

AWARD CLASS: COOPERATIVE AGREEMENT

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 09/01/2022

PERIOD OF PERFORMANCE END DATE: 12/31/2024

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