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.