A multi-site study, supported by a $2.1 million grant from the National Center for Advancing Translational Sciences (NCATS), will rigorously evaluate the impact of remote versus in-person approaches to clinical trials. The research aims to determine whether remote methods improve efficiency, quality, and equity in clinical trial participation, particularly for underrepresented populations.
The study, titled "Improving Efficiency, Quality, and Equity: Randomized Controlled Evaluations of Remote vs. In-Person Clinical Trial Methods," involves researchers from the University at Buffalo’s Clinical and Translational Science Institute (CTSI), Roswell Park Comprehensive Cancer Center, and Clinical and Translational Science Award (CTSA) hubs in South Carolina, Pennsylvania, and Alabama. Timothy F. Murphy, SUNY Distinguished Professor and CTSI director, emphasized the importance of this research, noting that while remote methods became prevalent during the COVID-19 pandemic, their effectiveness and impact on diverse populations require thorough assessment.
Evaluating Remote Trial Methods
The collaboration originated during the COVID-19 pandemic when researchers transitioned to remote methods for ongoing clinical trials. Larry Hawk, professor in the UB Department of Psychology, and Martin C. Mahoney, professor of oncology at Roswell Park, observed that while remote methods were becoming the "new normal," questions remained about their impact on recruiting underrepresented populations. "Has anybody formally and systematically evaluated remote trials?" Mahoney questioned, highlighting the need for evidence-based assessment.
Jennifer Dahne and Matthew Carpenter, both from the Department of Psychiatry and Behavioral Sciences at the Medical University of South Carolina (MUSC), are also key collaborators. Dahne's work focuses on improving the rigor and representativeness of remote trials, emphasizing the importance of evaluating interventions at a distance.
Study Design and Objectives
The study consists of two phases and will involve three clinical trials across four locations. The first trial, taking place at UB and UPenn with 200 participants, focuses on smoking cessation. The second trial, at MUSC, will address depression treatment, and the third, at UAB, will focus on opioid addiction. The latter two trials will each include 100 participants.
The primary research question across all trials is the impact of remote versus in-person screening and follow-up on accrual efficiency, study retention, and data quality. Researchers aim to determine if reducing barriers to in-person visits leads to more representative trials and advances health equity. However, they also acknowledge that technological and internet barriers could potentially reduce the representativeness of clinical trials, as highlighted in a 2023 JAMA article by Dahne and Hawk.
Dissemination and Future Impact
The findings will be disseminated through a web-based toolkit, semiannual webinars, and a national conference, supported in part by MUSC’s HRSA-funded Center of Excellence in Telehealth. The goal is to provide evidence-based guidance for researchers designing future clinical trials.
"We would like to re-engage the community of researchers who are designing trials to take half a step back and consider some of the evidence that will come out of these three smaller trials," Mahoney stated. Hawk added that the NCATS grant will help assess the beliefs surrounding remote trials and determine when to best utilize different approaches. Participant recruitment is scheduled to begin in early 2025.
