308 Stakeholder interview feedback to improve remote biomarker capture for decentralized trials

Objectives/Goals: We previously developed and evaluated a system called MyTrials, which captures biomarker data remotely. We sought to improve that platform to support additional methods of remote biomarker capture, which is especially important in research such as substance use and co-use studies where participants provide several biological verifications. Methods/Study Population: To determine how best to adapt MyTrials, we conducted qualitative interviews with key stakeholders. Our sample of end users (i.e., participants, N=10) included 6 women (3 men and 1 nonbinary participant), 6 White participants (2 Black participants, 1 Asian participant, and 1 multiracial participant), 6 participants with education beyond high school (4 participants with high school/GED), with a mean age of 36.33 years (age range: 21–75), and with a range of substance use behavior (combustible cigarettes [N=6], e-cigarettes [N=3], cannabis use [N=5], and no substance use [N=2]). Our sample of potential customers (N=22) included 12 research investigators, 2 biospecimen lab representatives, 3 research coordinators, 3 representatives from large NIH grant initiatives (ABCT, CTN, and CTSA), and 2 REDCap engineers/managers. Results/Anticipated Results: Emerging themes included 1) suggestions for technical requirements including reliability of core functions, app usability, support access, and data security/compliance and 2) suggestions for commercialization including clarity of instructions, operational logistics, trust in the data collection process, IRB/funder acceptance, and participant retention enablers. Discussion/Significance of Impact: Key feedback themes will inform product improvement to meet the needs for decentralized clinical trials to collect biological or health data without in-person participation.