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Digital Twins for Accelerating Clinical Trial Innovation in Alcohol-Associated Hepatitis

Award Number: K08AA033404
ORGANIZATION: NATIONAL INSTITUTE ON ALCOHOL ABUSE AND ALCOHOLISM
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: TRAINING/TRAINEESHIP
PERIOD OF PERFORMANCE START DATE: 08/19/2026
PERIOD OF PERFORMANCE END DATE: 07/31/2031

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Digital Twins for Accelerating Clinical Trial Innovation in Alcohol-Associated Hepatitis - PROJECT SUMMARY Alcohol-associated hepatitis (AH) is a severe form of liver disease and a leading cause of liver-related mortality in the U.S., yet the therapeutic landscape remains critically underserved. Clinical trials for new AH therapies are profoundly impaired by low patient enrollment and poor retention, creating a major bottleneck that has stalled therapeutic advancement for decades. To address these challenges, this proposal leverages an innovative approach using state-of-the-art artificial intelligence (AI) to create digital twins – virtual patient representations that can simulate disease trajectories and treatment response. Our central hypothesis is that digital twins, generated via advanced diffusion models, can effectively emulate randomized clinical trial results and simulate control group responses, enabling in-silico trial designs that reduce enrollment requirements while maintaining statistical rigor and privacy. Our strong preliminary data support this hypothesis, demonstrating the successful generation of high-fidelity synthetic hepatology datasets that preserve critical clinical relationships, survival outcomes, and patient privacy. Furthermore, we have successfully executed a full in-silico trial using digital twins, providing a robust proof-of-concept for our proposed methods. Building on this foundation, this project will pursue two specific aims: • Aim 1: Develop digital twins from a comprehensive, multi-institutional AH dataset and perform a target trial emulation of the landmark STOPAH study to validate the framework's ability to reproduce the findings of a large-scale randomized controlled trial. • Aim 2: Validate the digital twins for accurately simulating control group responses in both a completed (retrospective) and an ongoing (prospective) AH clinical trial conducted by the NIH-funded AlcHepNet consortium. This research is innovative as it represents the first systematic application of digital twins to overcome long- standing clinical trial barriers in AH. Successful completion will provide a validated platform to accelerate therapeutic development, reduce trial costs, and inform regulatory science for AI-driven clinical research. The institutional environment at Mayo Clinic provides unparalleled mentorship, access to extensive clinical datasets, and computational resources. This K08 mentored career development award is essential for my transition into an independent physician-scientist pioneering AI-driven precision medicine to improve outcomes for patients with alcohol-associated liver disease.


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 = $202,176 )
2026	2026	MAYO CLINIC	200 1ST ST SW	ROCHESTER	MN	55905	OLMSTED	USA	Alcohol Research Programs	000	1	8/21/2026	NEW	$202,176
														Subtotal = $202,176

Grand Total All Awards = $202,176

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Digital Twins for Accelerating Clinical Trial Innovation in Alcohol-Associated Hepatitis

Award Number: K08AA033404

ORGANIZATION: NATIONAL INSTITUTE ON ALCOHOL ABUSE AND ALCOHOLISM

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: TRAINING/TRAINEESHIP

PERIOD OF PERFORMANCE START DATE: 08/19/2026

PERIOD OF PERFORMANCE END DATE: 07/31/2031

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