Friday, December 12, 2025 12/12/2025

Global Cooperation to Promote Clinical Research in Children

Award Number: R13FD007293
ORGANIZATION: FOOD AND DRUG ADMINISTRATION
OPDIV: FDA
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 01/15/2021
PERIOD OF PERFORMANCE END DATE: 12/31/2023

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Global Cooperation to Promote Clinical Research in Children - FDA PA 19-306 Project Summary Bierer, Barbara E., M.D. Global Cooperation to Promote Clinical Research in Children Project Summary The Multi-Regional Clinical Trial (MRCT) Center of Brigham and Women’s Hospital and Harvard (MRCT Center) is a research and policy center created to address the conduct, oversight, ethics and regulatory environment of clinical trials, with a focus on multinational trials. To do the work, we function as an independent convener to engage diverse stakeholders from industry, CROs, academia, patients and patient advocacy groups, non-profit organizations, and global regulatory agencies to address problems in rigor and integrity of trials. In this submission, we propose to convene a series of 4 meetings, followed by a large public conference, of industry and academic pediatric trialists, regulators, and patient/patient advocates to discuss the challenges of pediatric clinical trials. This conference series is highly relevant to the FDA’s efforts to promote the evidence base of safety and efficacy of drugs, biologics, vaccines, and devices in the pediatric population through pediatric trials. Critical to the health of a population is the development and administration of safe and effective therapeutic products for children. Ensuring that children have access to safe and effective medicines is contingent upon the conduct of trials that enroll children and yet the smooth conduct of pediatric clinical trials is hampered by multiple barriers and challenges. The proposed conference series will build on the preliminary work of a current MRCT Center project that is exploring the ethical, regulatory, privacy and confidentiality concerns that impede the conduct of global clinical trials in children, with a particular emphasis on ex-US countries and low- and middle-income countries (LMICs). The proposed virtual conference series will involve broad international representative from both resource-poor and resource- rich countries and will delve into the following critical topics: 1. Analyze IRB/REC and regulatory expectations of approaches to pediatric clinical research across jurisdictions 2. Considerations for pediatric clinical trial networks across geographical boundaries: infrastructure, governance, and capacity in a network and network of networks 3. Alternative potential cooperative models for IRB/EC review of pediatric trials 4. Alternative potential cooperative models for regulatory review of pediatric trials 5. Public discussion of models to advance global cooperation in pediatric clinical research


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	2023	BRIGHAM & WOMENS HOSPITAL INC	75 FRANCIS ST	BOSTON	MA	02115	SUFFOLK	USA	Food and Drug Administration Research	000	3	4/29/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2023 ( Subtotal = $54,610 )
2023	2023	BRIGHAM & WOMENS HOSPITAL INC	75 FRANCIS ST	BOSTON	MA	02115	SUFFOLK	USA	Food and Drug Administration Research	003	3	9/25/2023	NON-COMPETING CONTINUATION	-$9,414
2023	2023	BRIGHAM & WOMENS HOSPITAL INC	75 FRANCIS ST	BOSTON	MA	02115	SUFFOLK	USA	Food and Drug Administration Research	000	3	3/21/2023	NON-COMPETING CONTINUATION	$54,610
2023	2023	BRIGHAM & WOMENS HOSPITAL INC	75 FRANCIS ST	BOSTON	MA	02115	SUFFOLK	USA	Food and Drug Administration Research	002	3	9/22/2023	NON-COMPETING CONTINUATION	$0
2023	2023	BRIGHAM & WOMENS HOSPITAL INC	75 FRANCIS ST	BOSTON	MA	02115	SUFFOLK	USA	Food and Drug Administration Research	001	3	9/15/2023	NON-COMPETING CONTINUATION	$0
2023	2023	BRIGHAM & WOMENS HOSPITAL INC	75 FRANCIS ST	BOSTON	MA	02115	SUFFOLK	USA	Food and Drug Administration Research	005	3	9/29/2023	NON-COMPETING CONTINUATION	$0
2023	2023	BRIGHAM & WOMENS HOSPITAL INC	75 FRANCIS ST	BOSTON	MA	02115	SUFFOLK	USA	Food and Drug Administration Research	004	3	9/28/2023	NON-COMPETING CONTINUATION	$9,414
														Subtotal = $54,610

Issue Date FY: 2022 ( Subtotal = $20,000 )
2022	2022	BRIGHAM AND WOMEN'S HOSPITAL, INC., THE	75 FRANCIS ST	BOSTON	MA	02115	SUFFOLK	USA	Food and Drug Administration Research	000	2	2/11/2022	NON-COMPETING CONTINUATION	$20,000
														Subtotal = $20,000

Issue Date FY: 2021 ( Subtotal = $141,013 )
2021	2021	BRIGHAM AND WOMEN'S HOSPITAL, INC., THE	75 FRANCIS ST	BOSTON	MA	02115	SUFFOLK	USA	Food and Drug Administration Research	001	1	5/26/2021	NEW	$61,112
2021	2021	BRIGHAM AND WOMEN'S HOSPITAL, INC., THE	75 FRANCIS ST	BOSTON	MA	02115	SUFFOLK	USA	Food and Drug Administration Research	000	1	1/20/2021	NEW	$79,901
														Subtotal = $141,013

Grand Total All Awards = $215,623

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Global Cooperation to Promote Clinical Research in Children

Award Number: R13FD007293

ORGANIZATION: FOOD AND DRUG ADMINISTRATION

OPDIV: FDA

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 01/15/2021

PERIOD OF PERFORMANCE END DATE: 12/31/2023

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