Implementation of Novel Remote Sampling Tools in Longitudinal Studies for Increased Participation and Accessibility

Abstract

Traditional clinical studies are often conducted in-person at large medical centers or universities, which can create logistical barriers for prospective participants. One way of circumventing these barriers is by adopting a remote study model where sample collection can be done in participants’ homes. The work presented herein illustrates the process of developing, piloting, and implementing tools for remote clinical research with the goal of making participation in clinical studies more accessible. In chapter 1, I introduce the current state of health research and remote studies. In chapter 2, we present the effects of the shipping process (from participant back to the lab) on the integrity of the RNA extracted from homeRNA-stabilized whole blood samples, with an emphasis on the considerations of RNA degradation from exposure to high temperatures. This work includes controlled in-lab experiments where samples are exposed to known temperatures (25℃, 37℃, 40℃, 45℃, and 50℃) for known time intervals (hours to days), as well as a real-life shipping experiment where blood from a single donor is sent to volunteers across the United States during the summer months. Here, we use the RNA Integrity Number (RIN) and sequencing data from 3’ mRNA-seq as metrics for successful preservation of sample RNA in the shipping process with the homeRNA platform. In chapter 3, we outline the process of updating the existing homeRNA platform to interface with a commercially available BD microtainer tube and to accommodate larger blood volumes (up to 1.5 mL). We pilot this new device, homeRNAmax, for usability in naïve users and demonstrate feasibility of implementation in a real-world clinical study. Finally, in chapter 4, I investigate the utility of remote research and homeRNA for reaching Underrepresented, Underserved, and Underreported (U3) populations in parallel to tracking early infection biomarkers in a cohort of 40 COVID-19+ women. The biospecimen collection is accompanied by comprehensive user experience surveys which are then examined to better understand factors contributing to the high participant retention (n = 39/40, 98%). The work presented herein illustrates the entire process of implementing new remote clinical tools, from their inception to their use in human subject studies. Taken together, I intend this compilation to serve as a roadmap for researchers and clinicians developing new remote sampling tools and as an instructive guide on how to make participation in clinical research more accessible.