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NIH Health Care Systems Research Collaboratory-Coordinating Center (U24)

Award Number: U24AT009676
ORGANIZATION: CENTER FOR DRUG EVALUATION AND RESEARCH, NIH
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/22/2022
PERIOD OF PERFORMANCE END DATE: 05/31/2028

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NIH Health Care Systems Research Collaboratory-Coordinating Center (U24) - ABSTRACT Over the past nine years, the Collaboratory Coordinating Center (CC) has worked with the NIH to nurture 21 Demonstration Projects by providing leadership, resources, tools, training, and coordination of diverse elements. Six of these trials were designed to speed scientific solutions for addressing the national opioid public health crisis. The CC maintains expert Core Working Groups and committees; supports dissemination and implementation efforts; and established the online Living Textbook of Pragmatic Clinical Trials to translate learnings for the research community. The Collaboratory CC has created and disseminated guidance so that investigators can work with health systems to embed their research in the delivery of health care, and use routinely collected health care information as a core data source for the full spectrum of clinical research, including randomized trials. The Collaboratory CC is also providing essential guidance to funders, reviewers, institutional review boards (IRBs), and data safety monitoring boards regarding the ethical and regulatory aspects of embedded pragmatic clinical trials (ePCTs). In this next phase of work, we will build on lessons learned and new experiences gleaned from the next set of Demonstration Projects to continue to refine the pragmatic trials model (Aims 1-3). During the next funding period, the Collaboratory CC will have the following Specific Aims: Specific Aim 1: Work collaboratively with each Demonstration Project team supported through the Collaboratory program, including their partnering health care systems, to develop, test, and implement the proposed Demonstration Projects while providing technical, design, and coordination support. Specific Aim 2: Further develop and refine technical and policy guidelines and best practices for the effective conduct of research studies in partnership with health care systems. Specific Aim 3: Learn, develop, and disseminate the best strategies for conducting successful embedded pragmatic clinical trials by engaging health care systems—including those with less historical involvement in research studies—as research partners to improve health and care delivery.


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 = $2,524,998 )
2024	2024	DUKE UNIVERSITY	2200 W MAIN ST	DURHAM	NC	27705	DURHAM	USA	Research and Training in Complementary and Integrative Health	001	8	9/3/2024	NON-COMPETING CONTINUATION	$1,524,998
2024	2024	DUKE UNIVERSITY	2200 W MAIN ST	DURHAM	NC	27705	DURHAM	USA	Research and Training in Complementary and Integrative Health	002	8	9/17/2024	NON-COMPETING CONTINUATION	$1,000,000
2024	2023	DUKE UNIVERSITY	2200 W MAIN ST	DURHAM	NC	27705	DURHAM	USA	Research and Training in Complementary and Integrative Health	000	7	8/15/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $2,524,998

Issue Date FY: 2023 ( Subtotal = $1,524,998 )
2023	2023	DUKE UNIVERSITY	2200 W MAIN ST	DURHAM	NC	27705	DURHAM	USA	Research and Training in Complementary and Integrative Health	005	7	9/13/2023	NON-COMPETING CONTINUATION	$1,524,998
2023	2022	DUKE UNIVERSITY	2200 W MAIN ST	DURHAM	NC	27705	DURHAM	USA	Research and Training in Complementary and Integrative Health	003	6	3/29/2023	COMPETING CONTINUATION	$1,059,616
2023	2022	DUKE UNIVERSITY	2200 W MAIN ST	DURHAM	NC	27705	DURHAM	USA	Research and Training in Complementary and Integrative Health	002	5	3/29/2023	SUPPLEMENT FOR EXPANSION	-$100,000
2023	2022	DUKE UNIVERSITY	2200 W MAIN ST	DURHAM	NC	27705	DURHAM	USA	Research and Training in Complementary and Integrative Health	000	6	1/12/2023	COMPETING CONTINUATION	$0
2023	2022	DUKE UNIVERSITY	2200 W MAIN ST	DURHAM	NC	27705	DURHAM	USA	Research and Training in Complementary and Integrative Health	004	6	7/7/2023	COMPETING CONTINUATION	$0
2023	2021	DUKE UNIVERSITY	2200 W MAIN ST	DURHAM	NC	27705	DURHAM	USA	Research and Training in Complementary and Integrative Health	001	5	3/29/2023	NON-COMPETING CONTINUATION	-$959,616
														Subtotal = $1,524,998

Issue Date FY: 2022 ( Subtotal = $1,624,999 )
2022	2022	DUKE UNIVERSITY	2200 W MAIN ST STE 710	DURHAM	NC	27708	DURHAM	USA	Research and Training in Complementary and Integrative Health	000	5	1/24/2022	SUPPLEMENT FOR EXPANSION	$100,000
2022	2022	DUKE UNIVERSITY	2200 W MAIN ST STE 710	DURHAM	NC	27708	DURHAM	USA	Research and Training in Complementary and Integrative Health	002	6	9/22/2022	COMPETING CONTINUATION	$1,524,999
2022	2021	DUKE UNIVERSITY	2200 W MAIN ST STE 710	DURHAM	NC	27708	DURHAM	USA	Research and Training in Complementary and Integrative Health	001	5	3/8/2022	NON-COMPETING CONTINUATION	$0
														Subtotal = $1,624,999

Issue Date FY: 2021 ( Subtotal = $1,900,000 )
2021	2021	DUKE UNIVERSITY	2200 W MAIN ST STE 710	DURHAM	NC	27708	DURHAM	USA	Research and Training in Complementary and Integrative Health	001	5	9/1/2021	NON-COMPETING CONTINUATION	$1,900,000
2021	2020	DUKE UNIVERSITY	2200 W MAIN ST STE 710	DURHAM	NC	27708	DURHAM	USA	Research and Training in Complementary and Integrative Health	000	4	11/2/2020	NON-COMPETING CONTINUATION	$0
														Subtotal = $1,900,000

Issue Date FY: 2020 ( Subtotal = $1,600,000 )
2020	2020	DUKE UNIVERSITY	2200 W MAIN ST STE 710	DURHAM	NC	27708	DURHAM	USA	Research and Training in Complementary and Integrative Health	005	4	9/8/2020	NON-COMPETING CONTINUATION	$0
2020	2020	DUKE UNIVERSITY	2200 W MAIN ST STE 710	DURHAM	NC	27708	DURHAM	USA	Research and Training in Complementary and Integrative Health	004	4	9/4/2020	NON-COMPETING CONTINUATION	$1,600,000
2020	2019	DUKE UNIVERSITY	2200 W MAIN ST STE 710	DURHAM	NC	27708	DURHAM	USA	Research and Training in Complementary and Integrative Health	000	3	1/15/2020	NON-COMPETING CONTINUATION	$0
2020	2019	DUKE UNIVERSITY	2200 W MAIN ST STE 710	DURHAM	NC	27708	DURHAM	USA	Research and Training in Complementary and Integrative Health	002	3	5/11/2020	NON-COMPETING CONTINUATION	$0
2020	2019	DUKE UNIVERSITY	2200 W MAIN ST STE 710	DURHAM	NC	27708	DURHAM	USA	Research and Training in Complementary and Integrative Health	003	3	7/20/2020	NON-COMPETING CONTINUATION	$0
2020	2019	DUKE UNIVERSITY	2200 W MAIN ST STE 710	DURHAM	NC	27708	DURHAM	USA	Research and Training in Complementary and Integrative Health	001	3	1/15/2020	SUPPLEMENT FOR EXPANSION	$0
														Subtotal = $1,600,000

Issue Date FY: 2019 ( Subtotal = $2,128,845 )
2019	2019	DUKE UNIVERSITY	2200 W MAIN ST STE 710	DURHAM	NC	27708	DURHAM	USA	Research and Training in Complementary and Integrative Health	003	3	9/9/2019	SUPPLEMENT FOR EXPANSION	$528,845
2019	2019	DUKE UNIVERSITY	2200 W MAIN ST STE 710	DURHAM	NC	27708	DURHAM	USA	Research and Training in Complementary and Integrative Health	002	3	9/6/2019	NON-COMPETING CONTINUATION	$1,600,000
2019	2018	DUKE UNIVERSITY	2200 W MAIN ST STE 710	DURHAM	NC	27708	DURHAM	USA	Research and Training in Complementary and Integrative Health	001	2	1/14/2019	SUPPLEMENT FOR EXPANSION	$0
2019	2018	DUKE UNIVERSITY	2200 W MAIN ST STE 710	DURHAM	NC	27708	DURHAM	USA	Research and Training in Complementary and Integrative Health	000	2	1/11/2019	NON-COMPETING CONTINUATION	$0
														Subtotal = $2,128,845

Issue Date FY: 2018 ( Subtotal = $3,607,008 )
2018	2018	DUKE UNIVERSITY	2200 W MAIN ST STE 710	DURHAM	NC	27708	DURHAM	USA	Research and Training in Complementary and Integrative Health	005	2	9/26/2018	SUPPLEMENT FOR EXPANSION	$1,370,393
2018	2018	DUKE UNIVERSITY	2200 W MAIN ST STE 710	DURHAM	NC	27708	DURHAM	USA	Research and Training in Complementary and Integrative Health	002	2	8/24/2018	NON-COMPETING CONTINUATION	$1,600,000
2018	2018	DUKE UNIVERSITY	2200 W MAIN ST STE 710	DURHAM	NC	27708	DURHAM	USA	Research and Training in Complementary and Integrative Health	003	2	8/25/2018	SUPPLEMENT FOR EXPANSION	$421,012
2018	2018	DUKE UNIVERSITY	2200 W MAIN ST STE 710	DURHAM	NC	27708	DURHAM	USA	Research and Training in Complementary and Integrative Health	004	2	9/26/2018	NON-COMPETING CONTINUATION	$0
2018	2018	DUKE UNIVERSITY	2200 W MAIN ST STE 710	DURHAM	NC	27708	DURHAM	USA	Research and Training in Complementary and Integrative Health	006	2	9/27/2018	SUPPLEMENT FOR EXPANSION	$64,341
2018	2017	DUKE UNIVERSITY	2200 W MAIN ST STE 710	DURHAM	NC	27708	DURHAM	USA	Research and Training in Complementary and Integrative Health	001	1	8/15/2018	NEW	$150,000
2018	2017	DUKE UNIVERSITY	2200 W MAIN ST STE 710	DURHAM	NC	27708	DURHAM	USA	Research and Training in Complementary and Integrative Health	000	1	11/29/2017	NEW	$1,262
														Subtotal = $3,607,008

Issue Date FY: 2017 ( Subtotal = $1,500,000 )
2017	2017	DUKE UNIVERSITY	2200 W MAIN ST STE 710	DURHAM	NC	27708	DURHAM	USA	Research and Training in Complementary and Integrative Health	000	1	9/11/2017	NEW	$1,500,000
														Subtotal = $1,500,000

Grand Total All Awards = $16,410,848

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NIH Health Care Systems Research Collaboratory-Coordinating Center (U24)

Award Number: U24AT009676

ORGANIZATION: CENTER FOR DRUG EVALUATION AND RESEARCH, NIH

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

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

PERIOD OF PERFORMANCE START DATE: 09/22/2022

PERIOD OF PERFORMANCE END DATE: 05/31/2028

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