A collaborative study involving researchers from the University at Buffalo Clinical and Translational Science Institute (CTSI), Roswell Park Comprehensive Cancer Center, and CTSA hubs in South Carolina, Pennsylvania, and Alabama has received a $2.1 million grant from the National Center for Advancing Translational Sciences (NCATS) to rigorously evaluate remote versus in-person clinical trial methods.
The study, titled "Improving Efficiency, Quality, and Equity: Randomized Controlled Evaluations of Remote vs. In-Person Clinical Trial Methods," addresses a critical need to assess the effectiveness and impact of remote trial methods, which gained prominence during the COVID-19 pandemic. While remote methods offer potential benefits such as reduced travel barriers, their impact on underrepresented populations and overall trial quality requires thorough investigation.
Rigorous Evaluation of Remote Trials
The multi-site collaboration originated during the COVID-19 pandemic when researchers transitioned to remote methods. Initial observations suggested that in-person attendance and biospecimen return were somewhat better compared to remote approaches. This prompted a deeper inquiry into whether the shift to remote trials would truly enhance recruitment of underrepresented groups.
"We came at it asking, what is the evidence? Has anybody formally and systematically evaluated remote trials?" said Martin C. Mahoney, MD, PhD, Roswell Park.
Study Design and Objectives
The study consists of two phases (UG3 and UH3) and will encompass three clinical trials across four geographic locations. The first trial, funded by the UG3 phase, will focus on smoking cessation and involve 200 participants at UB and UPenn. The subsequent trials will address depression treatment (at MUSC) and opioid addiction (at UAB), each involving 100 participants during the UH3 phase.
"For all of these studies the research question is the same," explains Jennifer Dahne, PhD, MUSC. "It is not about smoking cessation or depression treatment or opioid overdose prevention. Rather, it is about the impact of randomization to remote versus in-person screening on accrual efficiency, and then subsequent randomization to remote versus in-person follow-up on things like study retention and data quality."
Impact and Dissemination
The researchers aim to determine whether reducing barriers to in-person visits can lead to more representative trials and advance health equity. The findings will be disseminated through a web-based toolkit, semiannual webinars, and a national conference. Participant recruitment is scheduled to begin in early 2025.
"The grant from NCATS will allow us to assess the many beliefs around remote trials," adds Larry Hawk, PhD, University at Buffalo. "Are they justified, and we go full bore into that area? Or do we need to pause or be a little more calculating in when we take one approach versus another?"
