# Clinical Core

> **NIH NIH U54** · UNIV OF MASSACHUSETTS MED SCH WORCESTER · 2024 · $250,486

## Abstract

Project Summary/Abstract – Clinical Core
Point-of-care (POC) and home-based technologies are increasingly important tools for patients, caregivers, and
healthcare providers to diagnose and treat critical health issues. In acute care settings, clinicians and caregivers
need real-time data to guide management of potentially rapidly changing health conditions; in home settings,
providers seek new ways to better communicate and engage patients in promoting health and managing chronic
conditions. The commercialization and adoption of technologies sold over the counter and intended for home
use has been accelerated by the COVID-19 pandemic and increasingly allows for the realization of more
empowered and proactive patient care. As a Technology Research and Development Center (TRDC), the goal
of the Center for Advancing Point of Care Technologies (CAPCaT) is to develop and optimize novel POC
and home-based technologies to improve the diagnosis and treatment of Heart, Lung, Blood and Sleep
(HLBS) disorders. The CAPCaT Clinical Core will contribute to this goal by leveraging core competencies to
facilitate clinical validation and usability studies, especially those that address health inequity and can be used
in underserved communities. As the primary POC Technology Research Network (POCTRN) member
responsible for leading clinicals studies for RADx Tech, CAPCaT partnered with community organizations,
practice-based and academic clinical trial networks, members of the FDA and other regulators, and industry
partners to design and execute inclusive clinical studies involving over 15,000 participants from racially and
geographically diverse backgrounds.(1) The CAPCaT Clinical Core will capitalize on its unique infrastructure and
expert team to continue to provide support for the design and execution of clinical studies to demonstrate the
usability and efficacy of devices that advance disease management. To date, the CAPCaT Clinical Core has
worked successfully with its External Advisory Committee and Data Safety Monitoring Board to monitor, engage,
and support 23 HLBS innovators by providing technical, logistical, and operational support to CAPCaT teams
conducting later-stage clinical validation and usability studies, including demonstration studies that adapt
technologies for use in lower resource environments. Our team, experience and competencies make us uniquely
suited to provide the broad array of services that facilitate clinical research and support the development of
devices to improve the diagnosis and treatment of HLBS disorders and promote health equity. Our objectives in
achieving this goal are to continue: 1) Select clinically relevant POC and home-based technologies and design
innovative and inclusive clinical validation and usability studies; 2) Support CAPCaT clinical validation and
usability studies that engage key stakeholders to contextualize study findings and promote implementation.

## Key facts

- **NIH application ID:** 10908708
- **Project number:** 5U54HL143541-07
- **Recipient organization:** UNIV OF MASSACHUSETTS MED SCH WORCESTER
- **Principal Investigator:** David D. McManus
- **Activity code:** U54 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $250,486
- **Award type:** 5
- **Project period:** 2018-08-22 → 2028-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10908708

## Citation

> US National Institutes of Health, RePORTER application 10908708, Clinical Core (5U54HL143541-07). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10908708. Licensed CC0.

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