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Statistical inference for the efficacy and sustainability of interventions in clinical trials with high-dimensional endpoints

Award Number: R21LM014912
ORGANIZATION: NATIONAL LIBRARY OF MEDICINE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/23/2026
PERIOD OF PERFORMANCE END DATE: 08/31/2028

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Statistical inference for the efficacy and sustainability of interventions in clinical trials with high-dimensional endpoints - Project Summary Physical activity (PA) is an important modifiable risk factor for multiple health outcomes, yet fewer than 25% of the adults in the United States meet recommended guidelines. These findings prompt the development of intervention clinical trials to identify strategies for increasing and maintaining optimal PA levels. Wearable devices have been increasingly deployed in these studies to provide continuous, objective, and non-invasive assessment of PA. The large and complex datasets generated from these devices urge the need to develop new statistical methods for modeling the data while avoiding excessive compression. We propose innovative biostatistical methods that can scale to large datasets and provide inferential results for high-dimensional responses and high-dimensional or scalar predictors. While our methods are motivated by the PA intervention studies, they are broadly applicable to clinical trials with high-dimensional endpoints. The first Aim focuses on assessing the effectiveness of interventions by introducing novel inferential approaches for high-dimensional responses and developing methods for handling missing data in longitudinal studies. The second Aim is concerned with the sustainability of interventions and introduces a mixed effects function-on-function regression model and novel marginal inferential approaches.


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 = $177,858 )
2026	2026	REGENTS OF THE UNIVERSITY OF MINNESOTA	2221 UNIVERSITY AVE SE STE 100	MINNEAPOLIS	MN	55414	HENNEPIN	USA	Medical Library Assistance	000	1	9/19/2026	NEW	$177,858
														Subtotal = $177,858

Grand Total All Awards = $177,858

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Statistical inference for the efficacy and sustainability of interventions in clinical trials with high-dimensional endpoints

Award Number: R21LM014912

ORGANIZATION: NATIONAL LIBRARY OF MEDICINE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 09/23/2026

PERIOD OF PERFORMANCE END DATE: 08/31/2028

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