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Advancing equity through the Alliance for Representative Trials (ARC) program to diversify and bring industry-sponsored trials to communities of color and underrepresented communities

Award Number: U01FD007782
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: 08/31/2024

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Advancing equity through the Alliance for Representative Trials (ARC) program to diversify and bring industry-sponsored trials to communities of color and underrepresented communities - PROJECT SUMMARY / ABSTRACT Background. Representation of racial and ethnic minorities in clinical trials is needed to ensure that regulated medical products reflect and treat the intended treatment population and produce generalizable results; however, limited knowledge exists on the effectiveness of actionable solutions to improve diversity in clinical trials as well as cost-efficient ways to increase community practitioner and clinician capacity to participate in clinical research. Goal. The primary project goal is to demonstrate that minority-serving community clinicians can be trained and certified to be principal investigators (PIs) for randomized clinical trials and real world studies as well as upgrade their practices as trial sites. Methods. To achieve the the goal, the Alliance for Representative Clinical Trials (ARC), a multi-sponsor public/private program organized to diversify and bring clinical trials to communities of color and other communities that have been underrepresented in clinical trials, will be scaled up by increasing the number of minority-serving clinicians who have been trained to be principal investigators (PI) to lead drug and device randomized clinical trials. We propose to develop the knowledge, products, and processes needed to expand the ARC initiative. Our research question is: Will ARC be successfully adopted, implemented, and sustained through existing channels using this implementation process? A case study will be implemented to evaluate the effectiveness of the ARC initiative on improving minority-serving practitioners' and clinicians' capacity to participate in clinical research in a 12-month period. Objectives. The proposed project will train and certify community clinicians to be PIs, place study coordinators in their practice, and upgrade their logistical systems so they can support clinical trials. Once certified as PIs, these practices will be enrolled in the Clinical Investigative Site Network (CISN) as a clinical trial site. Certified practices will immediately be offered the opportunity to be an investigative site for several privately funded studies that CISN is managing, and CISN will continuously reach out to public/private trial sponsors to bring other study opportunities to them. Dissemination and Innovation. A project evaluation will be conducted to ensure that the tools and interventions used are effective, responsive, and equipped for widespread dissemination when the funding ends. To prepare for dissemination, we will consult with the Association of Black Cardiologists to refine ARC processes and practices and utilize an Evaluation Board to evaluate and guide project activities. Project results are likely to impact the field by improving technical abilities and clinical practice to: recruit and train minority-serving community clinicians to implement clinical trials; create a sustainable solution to improving the recruitment and retention of diverse populations in clinical trials; and create an infrastructure for community clinics to participate in clinical trials, increasing the accessibility of trials to underrepresented groups. The proposed project is innovative because it systematically examines the process of expanding the ARC initiative, a potentially sustainable solution to improving diversity in clinical trials.


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: 2024 ( Subtotal = $0 )
2024	2022	NATIONAL MINORITY QUALITY FORUM INC.	1201 15TH ST NW	WASHINGTON	DC	20005	DISTRICT OF COLUMBIA	USA	Food and Drug Administration Research	000	1	11/20/2023	NEW	$0
2024	2022	NATIONAL MINORITY QUALITY FORUM INC.	1201 15TH ST NW	WASHINGTON	DC	20005	DISTRICT OF COLUMBIA	USA	Food and Drug Administration Research	001	1	9/25/2024	NEW	$0
														Subtotal = $0

Issue Date FY: 2023 ( Subtotal = $0 )
2023	2022	NATIONAL MINORITY QUALITY FORUM INC.	1201 15TH ST NW	WASHINGTON	DC	20005	DISTRICT OF COLUMBIA	USA	Food and Drug Administration Research	001	1	7/20/2023	NEW	$0
2023	2022	NATIONAL MINORITY QUALITY FORUM INC	1201 15TH ST NW	WASHINGTON	DC	20005	DISTRICT OF COLUMBIA	USA	Food and Drug Administration Research	000	1	5/3/2023	NEW	$0
														Subtotal = $0

Issue Date FY: 2022 ( Subtotal = $496,430 )
2022	2022	NATIONAL MINORITY QUALITY FORUM INC	1201 15TH ST NW STE 340	WASHINGTON	DC	20005	DISTRICT OF COLUMBIA	USA	Food and Drug Administration Research	000	1	8/16/2022	NEW	$496,430
														Subtotal = $496,430

Grand Total All Awards = $496,430

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Advancing equity through the Alliance for Representative Trials (ARC) program to diversify and bring industry-sponsored trials to communities of color and underrepresented communities

Award Number: U01FD007782

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: 08/31/2024

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