MyTrials: An Integrated Tool to Support Remote Biomarker Capture within Decentralized Clinical Trials for Substance Use Disorders - PROJECT SUMMARY/ABSTRACT Decentralized clinical trials (DCTs) for substance use disorders (SUDs) face a significant methodological limitation: the need for biomarker collection. Though multiple approaches for remote SUD-relevant biomarker capture exist, translational research barriers limit the utility of these approaches for SUD DCTs. First, existing biomarker capture solutions have been developed primarily for clinical, not research, utilization. Thus, there are research and commercial needs to integrate remote biomarker capture with existing data infrastructure. Second, capture of each biospecimen typically functions independently, making collection of multiple biospecimens in any one trial burdensome. This problem is particularly relevant for SUD research as half of individuals who use substances use more than one, typically necessitating separate biomarker collection for each substance used. There is clear need for a product that can facilitate collection of multiple biomarkers in any one SUD DCT. To have maximum appeal, a product that will fill this gap must be able to be integrated in multiple trials across institutions. Our team is at the forefront of innovating DCT methods, with our research shared in prominent outlets such as JAMA. As part of our work, we recently completed prototype development of an integrated remote biomarker capture system (called “MyTrials”) for DCTs. Development of the MyTrials prototype was funded by a Phase I STTR from NCATS, and the product leverages REDCap, an online research data capture system with 2.9 million users that is freely available to research institutions. This prototype was not developed for SUD research and does not facilitate capture of substance use-specific biomarkers. Thus, while our foundational work supports technical feasibility, additional product refinements are needed to maximize applicability to SUD DCTs. Within this fast-track STTR, we will develop, refine, and evaluate a customized version of MyTrials to support the unique needs of SUD DCTs. During Phase I, MountainPass Technology LLC and MUSC will partner to develop MyTrials consistent with established needs of SUD DCTs and feedback gathered during focus groups with end-users and customers. Product development will build upon our MyTrials prototype with iterative refinements completed in response to usability testing with end-users. During Phase II, we will conduct a decentralized trial to evaluate the feasibility and acceptability of MyTrials among individuals who use substances. Study participants (N=450) will be enrolled remotely and asked to use MyTrials weekly for 12 weeks. Configuration of MyTrials will be matched to the participant’s current substance use. Main outcomes include: 1) assessment completion rates, 2) percent of valid biospecimens submitted, 3) product usability, and 4) feasibility and acceptability. Research activities are coupled with a strong commercialization plan which together will propel our company toward Phase III and will address the pressing need for research tools to support SUD DCTs.
