Clinical Core

Abstract:

Cancer is projected to be the leading cause of global mortality over the next decade and >75% of cancer deaths will occur in LMICs. Moreover, underserved areas face disproportionately higher cancer‐related morbidity, in large part due to inadequate screening and prevention. Lack of access results in initial diagnosis at an advanced and/or incurable stage.

There is a great need to develop affordable, accurate POC tests for cancer screening and early cancer detection that can be used by local providers and community health workers, and even by patients and families in their homes. There is an equally great need to validate these technologies in racially and socio‐economically diverse populations and in lower

resource settings, with all their environmental and cultural challenges. Indeed, cancer preventive strategies that work in

HICs often fail in LMICs (and underserved areas of high‐income countries) due to differences in disease characteristics, health system capacities, environmental (and environmental exposure) differences, as well as racial and genetic

differences. The primary goal of the Clinical Core (CC) is to serve as a “clinical laboratory for innovators” by providing infrastructure and services to support clinical validation of POC technologies and to evaluate implementation outcomes

for equitable cancer care. The CC will collaborate to validate prototype technologies and establish feasibility and adoption

of these devices in a diverse array of appropriate settings. The first aim of the CC is to evaluate clinical performance,

effectiveness, and usability of prototype POC technologies for cancer early detection in real‐world clinical settings, including technologies to address cancer health disparities. The second aim is to evaluate implementation of POC technologies for cancer prevention and early detection, including clinical impact, cost effectiveness and

barriers/facilitators to implementation in diverse clinical settings. Our multidisciplinary team (clinical researchers, engineers, pathologists, biostatisticians, veterinarians, research coordinators and regulatory managers) has worked

collaboratively for > 15-years on five continents, translating technologies from the bench to animal studies and clinical

trials in the USA, China, India, Africa, Europe and Latin America. We will bring this wealth of experience to facilitate POC

technology validation in highly diverse global settings (US, Mozambique, Brazil etc.). Likewise, we will leverage the core

support of the Texas Medical Center and Baylor (simulation, biostatistics, comparative biology/animal) to provide a clinical

core that provides high quality support, in both depth (translation, validation, regulatory) and breadth (international).

Through these aims, the CC will work with other CITEC cores to evaluate and advance a robust pipeline of POC technologies for equitable cancer care by identifying high priority unmet screening and early detection needs and ensuring that high impact technologies are developed, translated and evaluated in a rigorous and safe way that allows implementation,

commercialization and scale‐up.