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Leveraging electronic health records to optimize treatment selection and response in multiple sclerosis

Award Number: R01NS098023
ORGANIZATION: NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/30/2016
PERIOD OF PERFORMANCE END DATE: 12/31/2027

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Leveraging electronic health records to optimize treatment selection and response in multiple sclerosis - PROJECT SUMMARY AND ABSTRACT The rapid expansion of approved multiple sclerosis (MS) disease-modifying therapies (DMTs) and the diverse individual variation in treatment response contribute to the critical unmet need for individually tailored treatment strategy for the nearly 3 million persons with multiple sclerosis (pwMS) worldwide. The shift towards a precision medicine approach to guide treatment selection based on individual profiles will improve patient outcome by ensuring prompt initiation of effective DMTs while avoiding ineffective DMTs. To fill the knowledge gaps due to the absence of randomized clinical trial evidence and to advance precision medicine for pwMS, it is crucial to harness available clinical data and develop approaches deployable at the point of care. Electronic health records (EHR) data contain a wealth of longitudinal real-world clinical information and provide a complementary platform for clinical discovery. Building on our prior research efforts, the proposed study has the overall goal to optimize DMT selection and patient outcomes in pwMS using EHR data. We will use EHR data from two academic healthcare systems, both ideally positioned as they contain longitudinal clinical information of thousands of pwMS and hold crucial linkage to MS research registries that provide the ground truth. For additional validation, we will use integrated claims and EHR data from a large population of commercially insured pwMS. Aim 1: Compare relapse outcomes across DMTs. We will test the hypothesis that confounder correction using full EHR features yields more robust and consistent results in DMT effectiveness comparison analysis than expert-selected covariates. We will test the generalizability by using a transfer learning approach. Aim 2: Identify patient clusters based on DMT prescription sequences over time. We will test the hypothesis that DMT prescription sequences inform differential patient clusters and MS outcomes. We will apply a covariate-adjusted mixture Markov Model. Aim 3: Identify optimal DMT sequences that predict favorable treatment response. We will test the hypothesis that optimized DMT prescription sequence(s) through reinforcement learning could improve MS outcomes (i.e., relapse rate, patient-reported outcomes). This research will close knowledge gaps due to absent randomized clinical trial evidence and limited real-world evidence to guide optimal MS treatment selection. It will bring precision medicine closer to pwMS by developing clinically deployable strategies to optimize treatment selection. This project is consistent with the mission of the NINDS to reduce the burden of neurological diseases such as MS.


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: 2026 ( Subtotal = $574,100 )
2026	2026	UNIVERSITY OF PITTSBURGH - OF THE COMMONWEALTH SYSTEM OF HIGHER EDUCATION	4200 FIFTH AVENUE	PITTSBURGH	PA	15260	ALLEGHENY	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	9	1/31/2026	NON-COMPETING CONTINUATION	$574,100
														Subtotal = $574,100

Issue Date FY: 2025 ( Subtotal = $560,643 )
2025	2025	UNIVERSITY OF PITTSBURGH - OF THE COMMONWEALTH SYSTEM OF HIGHER EDUCATION	4200 FIFTH AVENUE	PITTSBURGH	PA	15260	ALLEGHENY	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	8	12/10/2024	NON-COMPETING CONTINUATION	$560,643
														Subtotal = $560,643

Issue Date FY: 2024 ( Subtotal = $595,341 )
2024	2024	UNIVERSITY OF PITTSBURGH - OF THE COMMONWEALTH SYSTEM OF HIGHER EDUCATION	4200 FIFTH AVENUE	PITTSBURGH	PA	15260	ALLEGHENY	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	001	7	4/25/2024	NON-COMPETING CONTINUATION	$42,962
2024	2024	UNIVERSITY OF PITTSBURGH - OF THE COMMONWEALTH SYSTEM OF HIGHER EDUCATION	4200 FIFTH AVENUE	PITTSBURGH	PA	15260	ALLEGHENY	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	7	1/10/2024	NON-COMPETING CONTINUATION	$552,379
														Subtotal = $595,341

Issue Date FY: 2023 ( Subtotal = $678,220 )
2023	2023	UNIVERSITY OF PITTSBURGH - OF THE COMMONWEALTH SYSTEM OF HIGHER EDUCATION	4200 FIFTH AVENUE	PITTSBURGH	PA	15260	ALLEGHENY	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	6	12/20/2022	COMPETING CONTINUATION	$678,220
2023	2023	UNIVERSITY OF PITTSBURGH - OF THE COMMONWEALTH SYSTEM OF HIGHER EDUCATION	4200 FIFTH AVENUE	PITTSBURGH	PA	15260	ALLEGHENY	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	003	6	12/30/2022	COMPETING CONTINUATION	$27,940
2023	2020	UNIVERSITY OF PITTSBURGH - OF THE COMMONWEALTH SYSTEM OF HIGHER EDUCATION	4200 FIFTH AVENUE	PITTSBURGH	PA	15260	ALLEGHENY	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	002	5	12/30/2022	SUPPLEMENT FOR EXPANSION	-$15,216
2023	2020	UNIVERSITY OF PITTSBURGH - OF THE COMMONWEALTH SYSTEM OF HIGHER EDUCATION	4200 FIFTH AVENUE	PITTSBURGH	PA	15260	ALLEGHENY	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	001	5	12/30/2022	NON-COMPETING CONTINUATION	-$12,724
														Subtotal = $678,220

Issue Date FY: 2020 ( Subtotal = $747,933 )
2020	2020	UNIVERSITY OF PITTSBURGH THE	3520 FIFTH AVE	PITTSBURGH	PA	15213	ALLEGHENY	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	5	6/1/2020	NON-COMPETING CONTINUATION	$340,616
2020	2020	UNIVERSITY OF PITTSBURGH THE	3520 FIFTH AVE	PITTSBURGH	PA	15213	ALLEGHENY	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	001	5	7/16/2020	SUPPLEMENT FOR EXPANSION	$407,317
														Subtotal = $747,933

Issue Date FY: 2019 ( Subtotal = $298,872 )
2019	2019	UNIVERSITY OF PITTSBURGH THE	3520 FIFTH AVE	PITTSBURGH	PA	15213	ALLEGHENY	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	4	6/24/2019	NON-COMPETING CONTINUATION	$298,872
														Subtotal = $298,872

Issue Date FY: 2018 ( Subtotal = $344,656 )
2018	2018	UNIVERSITY OF PITTSBURGH THE	3520 FIFTH AVE	PITTSBURGH	PA	15213	ALLEGHENY	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	3	7/18/2018	NON-COMPETING CONTINUATION	$344,656
														Subtotal = $344,656

Issue Date FY: 2017 ( Subtotal = $344,715 )
2017	2017	UNIVERSITY OF PITTSBURGH THE	3520 FIFTH AVE	PITTSBURGH	PA	15213	ALLEGHENY	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	2	6/16/2017	NON-COMPETING CONTINUATION	$344,715
														Subtotal = $344,715

Issue Date FY: 2016 ( Subtotal = $370,421 )
2016	2016	UNIVERSITY OF PITTSBURGH	FIFTH & BIGELOW BOULEVARD	PITTSBURGH	PA	15213	ALLEGHENY	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	1	9/23/2016	NEW	$370,421
														Subtotal = $370,421

Grand Total All Awards = $4,514,901

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Leveraging electronic health records to optimize treatment selection and response in multiple sclerosis

Award Number: R01NS098023

ORGANIZATION: NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 09/30/2016

PERIOD OF PERFORMANCE END DATE: 12/31/2027

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