Clinical Core

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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.