Development and Evaluation of an Integrated Biomarker Capture System for Use in Remote Trials

ABSTRACT Remote trials are led and coordinated by a local investigative team, but are based remotely, typically in the participant’s home. Remote trials offer several advantages over traditional in-person trials including: 1) a wider participant pool, 2) reduced regulatory hurdles, and 3) reduced participant burden. Remote trials face one key methodological limitation: the need for biomarker collection. Over the last decade, a multitude of Bluetooth- enabled remote patient monitoring (RPM) devices have become available which could allow researchers to capture biomarkers remotely. However, several key translational research barriers currently limit widespread integration of RPM devices for remote biospecimen collection. There is need to: 1) integrate RPM devices with existing research data infrastructure, 2) facilitate deployment of multiple devices in any one trial, and 3) flexibly integrate RPM devices into trials across institutions. Directly aligned with the NCATS STTR program, the goal of this Phase I STTR is to develop, refine, and evaluate an integrated digital RPM solution for remote trials (“MyTrials”). To accomplish this goal, we will leverage REDCap, an online research data capture system that is freely available to research institutions. REDCap has 1.7million users across more than 5,000 institutions in 141 countries. Via an established partnership between MountainPass Technology LLC and the Medical University of South Carolina, we will develop MyTrials consistent with feedback gathered during focus groups with end-users and customers. Product development will build upon Dr. Dahne’s ongoing NCI-funded R21 (CA241842) in which she has integrated one RPM device, a Bluetooth-enabled carbon monoxide monitor for assessment of smoking, with REDCap. MyTrials will subsequently be improved via iterative usability testing and refinements. We will then conduct a pilot feasibility trial in which study participants (N=48) will be enrolled remotely and randomized to either a self-report assessment only control or use of one, two, or three RPM devices. Main outcomes, which will be assessed weekly across four weeks, include: 1) assessment completion rates, 2) percent of submitted assessments with usable data, 3) product usability, and 4) participant reported feasibility and acceptability. Feasibility and acceptability benchmarks to make a go/no go decision to advance to Phase II include: 1) 80% biospecimen submission rate in each group, 2) 90% of submitted biospecimens with usable data defined as successfully submitted and accompanied by a photo confirming participant identity, 3) high product usability on the System Usability Scale (average of 68 in each group), and 4) end-user self-reported feasibility and acceptability on the Feasibility and Acceptability of Intervention Measures (scores of 4 in each group). Research activities are coupled with strong commercialization opportunities which will propel our company toward Phase II and beyond to improve the feasibility, efficiency, and rigor of remote human subjects research.PROJECT NARRATIVE Remote trials face one key methodological limitation: the need for biomarker collection. To address this gap, the goal of this Phase I STTR is to develop, refine, and evaluate an integrated digital remote patient monitoring solution for remote trials (“MyTrials”). Phase I research activities are coupled with strong commercialization opportunities which will propel our company toward Phase II and beyond to improve the feasibility, efficiency, and rigor of remote human subjects research.