# University of Rochester Hub and Spokes for the EPPIC Network - Specialized Clinical Center

> **NIH NIH U24** · UNIVERSITY OF ROCHESTER · 2024 · $110,001

## Abstract

PROJECT SUMMARY / ABSTRACT
The NIH's HEAL Initiative aims to support collaboration between clinical research experts in academia and
industry to accelerate the development of highly efficacious, non-addictive analgesics for well-defined chronic
pain syndromes. The University of Rochester (UR), and its proposed leadership for the UR Hub and Spokes
within Early Phase Pain Investigation Clinical Network (EPPIC-Net), have extensive expertise in designing and
conducting analgesic trials of small molecule drugs, devices, and biologics. These trials have included both
investigator-initiated phase 2 trials and participation multi-site industry-sponsored clinical trials with a main
focus on well-phenotyped chronic low back pain (CLBP) syndromes, which is one of the top priorities for the
NIH's proposed EPPIC-Net. Currently, there are thirteen committed potential protocol PIs at the UR Hub and
four Spokes. Together these PIs have the ability to recruit subjects with a broad range of pain conditions from
the following subspecialties: anesthesiology, dentistry, emergency medicine, gastroenterology, gynecology,
neurology, neurosurgery, oncology, orthopedics, pediatrics, rheumatology, and urology. Each of these
committed potential PIs has extensive clinical trial experience and existing infrastructure to support patient
recruitment and retention, timely and accurate data entry, and regulatory documentation. In addition, the
proposed UR-EPPIC-Net Collaboration Core is well equipped to recruit additional Spoke sites using the
members' broad, regional and national network of analgesic researchers. UR has multiple resources to
promote efficient subject recruitment and trial quality, including (1) the UR Clinical and Translational Science
Institute's Trial Hub Liaison Team and Recruitment Unit, Community Engagement Studios, and Clinical
Research Center; (2) the Practice-Based Research Network of regional primary care practices; and (3) the
Office for Human Subject Protection – Quality improvement division. The UR also has multiple resources to
support deep phenotyping of chronic pain patients, including (1) the Neuroimaging Core, (2) the
Neuromuscular Pathology Laboratory, (3) quantitative sensory testing expertise, and (4) the Physical Exercise
Activity Kinesiology Laboratory. This proposal outlines a leadership and oversight infrastructure to allow for the
nimble, efficient, and high integrity implementation of EPPIC-Net clinical trials. Institutional leadership
commitments include the use of a central Institutional Review Board (IRB) and the adoption and
implementation of master trial agreements templates. As a result, the proposed UR-EPPIC-Net Hub and
Spokes are well positioned to work with the EPPIC-Net Data and Clinical Coordination Centers to design and
rapidly conduct phase II therapeutic trials across a broad range of pain conditions, and to set new standards
for conception, implementation, and dissemination of pain research.

## Key facts

- **NIH application ID:** 11081913
- **Project number:** 4U24NS113784-02
- **Recipient organization:** UNIVERSITY OF ROCHESTER
- **Principal Investigator:** Jennifer Gewandter
- **Activity code:** U24 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $110,001
- **Award type:** 4N
- **Project period:** 2019-09-30 → 2025-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/11081913

## Citation

> US National Institutes of Health, RePORTER application 11081913, University of Rochester Hub and Spokes for the EPPIC Network - Specialized Clinical Center (4U24NS113784-02). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/11081913. Licensed CC0.

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