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Migraine Clinical Outcome Assessment System (MiCOAS)

Award Number: UH3FD006795
ORGANIZATION: FOOD AND DRUG ADMINISTRATION
OPDIV: FDA
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/10/2019
PERIOD OF PERFORMANCE END DATE: 08/31/2026

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Migraine Clinical Outcome Assessment System (MiCOAS) - PROJECT SUMMARY ABSTRACT The proposed Migraine Clinical Outcome Assessment System (MiCOAS) aims to improve and standardize endpoints and the assessment of those endpoints in migraine clinical trials. Such standardized clinical outcome assessments (COAs), developed to incorporate the patient voice and empirically supported by gold-standard instrument development techniques, will aid in the interpretability of results from and across migraine clinical trials and, by extension, advance the development and approval of migraine treatments. The UG3 phase of the grant will first assemble a group of stakeholders (substantive research experts, patient advocates, clinicians, psychometricians, regulators, and payers) to guide the project (AIM 1). Comprehensive systematic review of the migraine literature will be undertaken to fully understand current migraine outcomes, in both acute and preventative migraine trials (AIM 2). Results from qualitative research using patient-centered interviews (AIM 3) will ensure that endpoints identified during AIM 1 and AIM 2 as targets for development/refinement are meaningful to patients. The UH3 grant stage will use additional patient-centered qualitative research to fully understand the patient experience with respect to the target endpoints identified in UG3 and what aspects are most important to them, patient language in discussing said endpoints, and any possible areas of study that were not previously identified (AIM 4). Using the patient-interview results, outcome measures will be developed using gold- standard techniques. In the expected case of developing/refining a preventative quality-of- life/impact/disability-type measure, a new data collection of migraine patients will be designed and executed and gold-standard psychometric techniques will be employed to empirically evaluate and refine candidate items, finalize the items selected to the final assessment, and evaluate the initial validity and fit-for-purpose of the outcome assessment. A separate data collection will also be designed, executed, and analyzed for the draft outcome assessments intended for acute migraine trials (AIM 5). The overarching purpose of this grant is to develop a publicly available core set of migraine endpoints and their related COAs for migraine. Given this, proper dissemination of findings through scientific outlets in the form of presentations and manuscripts is essential (AIM 6). Successful completion of the overall goal of the proposed project will result in standardized and empirically-supported migraine COAs for clinical trials that are meaningful to patients and statistically robust.


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 = $0 )
2025	2022	VECTOR PSYCHOMETRIC GROUP, LLC	847 EMILY LN	CHAPEL HILL	NC	27516	ORANGE	USA	Food and Drug Administration Research	000	4	8/8/2025	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2024 ( Subtotal = $0 )
2024	2022	VECTOR PSYCHOMETRIC GROUP, LLC	847 EMILY LN	CHAPEL HILL	NC	27516	ORANGE	USA	Food and Drug Administration Research	000	4	9/7/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2023 ( Subtotal = $0 )
2023	2022	VECTOR PSYCHOMETRIC GROUP, LLC	847 EMILY LN	CHAPEL HILL	NC	27516	ORANGE	USA	Food and Drug Administration Research	001	4	8/9/2023	NON-COMPETING CONTINUATION	$0
2023	2022	VECTOR PSYCHOMETRIC GROUP, LLC	847 EMILY LN	CHAPEL HILL	NC	27516	ORANGE	USA	Food and Drug Administration Research	000	4	5/8/2023	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2022 ( Subtotal = $1,130,111 )
2022	2022	VECTOR PSYCHOMETRIC GROUP, LLC	847 EMILY LN	CHAPEL HILL	NC	27516	ORANGE	USA	Food and Drug Administration Research	002	4	8/5/2022	NON-COMPETING CONTINUATION	$1,130,111
2022	2021	VECTOR PSYCHOMETRIC GROUP, LLC	847 EMILY LN	CHAPEL HILL	NC	27516	ORANGE	USA	Food and Drug Administration Research	000	3	10/26/2021	NON-COMPETING CONTINUATION	-$1,628,800
2022	2021	VECTOR PSYCHOMETRIC GROUP, LLC	847 EMILY LN	CHAPEL HILL	NC	27516	ORANGE	USA	Food and Drug Administration Research	001	3	10/27/2021	NON-COMPETING CONTINUATION	$1,628,800
														Subtotal = $1,130,111

Issue Date FY: 2021 ( Subtotal = $1,941,891 )
2021	2021	VECTOR PSYCHOMETRIC GROUP, LLC	847 EMILY LN	CHAPEL HILL	NC	27516	ORANGE	USA	Food and Drug Administration Research	002	3	8/17/2021	NON-COMPETING CONTINUATION	$1,628,800
2021	2021	VECTOR PSYCHOMETRIC GROUP, LLC	847 EMILY LN	CHAPEL HILL	NC	27516	ORANGE	USA	Food and Drug Administration Research	001	2	6/14/2021	SUPPLEMENT FOR EXPANSION	$313,091
2021	2020	VECTOR PSYCHOMETRIC GROUP, LLC	847 EMILY LN	CHAPEL HILL	NC	27516	ORANGE	USA	Food and Drug Administration Research	000	2	1/26/2021	NON-COMPETING CONTINUATION	$0
														Subtotal = $1,941,891

Grand Total All Awards = $3,072,002

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Migraine Clinical Outcome Assessment System (MiCOAS)

Award Number: UH3FD006795

ORGANIZATION: FOOD AND DRUG ADMINISTRATION

OPDIV: FDA

AWARD CLASS: COOPERATIVE AGREEMENT

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

PERIOD OF PERFORMANCE START DATE: 09/10/2019

PERIOD OF PERFORMANCE END DATE: 08/31/2026

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