NCATS award to support multi-site study evaluating remote trials

Investigators from UB’s Clinical and Translational Science Institute (CTSI) were among those from several institutions who were recently awarded a two-year, $2.1 million grant from NCATS (National Center for Advancing Translational Sciences) to evaluate the impact of remote versus in-person approaches to clinical trials.

In addition to CTSI, the multi-site study includes researchers from Roswell Park Comprehensive Cancer Center and CTSA (Clinical and Translational Science Award) hubs in South Carolina, Pennsylvania and Alabama.

Assuming milestones from the first two years are met, the grant includes an additional three years of funding.

The CTSA Collaborative and Innovative Acceleration Award (CCIA) from NCATS provides support to investigators who are tackling a translational science problem that requires collaboration and innovation. Timothy F. Murphy, SUNY Distinguished Professor and CTSI director, notes the study, titled “Improving Efficiency, Quality, and Equity: Randomized Controlled Evaluations of Remote vs. In-Person Clinical Trial Methods,”  is the first CCIA received by the UB CTSI.

“This CCIA investigates a key question in clinical and translational science,” Murphy explains. “Remote methods for recruitment to clinical trials were implemented widely during the COVID pandemic. Following that experience triggered by necessity, remote methods are being used increasingly. However, these methods have not been assessed rigorously. For example, are remote methods more effective, less effective or unchanged for underrepresented populations in clinical trials? Remote methods reduce some barriers (such as travel), but increase others (like internet access and trust). This innovative study will assess these important questions.”

The study involves four CTSA hubs: the UB CTSI; the Medical University of South Carolina (MUSC) South Carolina Clinical & Translational Research Institute (SCTR); the University of Pennsylvania Institute for Translational Medicine and Therapeutics (UPenn); and the University of Alabama at Birmingham Center for Clinical and Translational Science (UAB).

The roots of the multi-site collaboration date back to the early days of the COVID-19 pandemic. Larry Hawk, professor in the UB Department of Psychology, and Martin C. Mahoney, professor of oncology at Roswell Park and clinical professor in the UB Department of Epidemiology and Environmental Health, were in the process of running a clinical trial as the pandemic began.

“Like everybody else, we quickly threw ourselves into trying to transition to remote work, with participants completing their visits from home via videoconference and mailing saliva samples back to us,” Hawk explains. “Then, as the dust settled, we authored a paper that suggested that attendance and biospecimen return were somewhat better for in-person compared to remote.”

The predominant line of thought in the literature, Hawk says, was that remote was the “new normal,” and that many clinical trials would never return to an in-person format.

“At the same time, a smaller group of people were saying, ‘Hold on — is this really going to help us recruit people who are underrepresented in clinical trials?’ Martin and I wanted to do a study on that.”

Adds Mahoney: “We came at it asking, what is the evidence? Has anybody formally and systematically evaluated remote trials?”

Hawk and Mahoney reached out to Jennifer Dahne, associate professor, and Matthew Carpenter, professor, both in the Department of Psychiatry and Behavioral Sciences at MUSC and co-directors of MUSC’s Remote & Virtual Trials Program. Dahne’s work centers around development and evaluation of technology-based remote interventions for the treatment of smoking cessation and common comorbidities, and on methods to improve the feasibility and rigor of remote trials.

A lengthy collaboration followed — one that ultimately resulted in the CCIA.

“One of the things that's been most interesting about collaborating with Larry, Martin and our colleagues at UAB and UPenn has been considering the way I have been doing trials for my whole career,” Dahne says. “How do we improve our methods for evaluating these interventions at a distance and maximize rigor and representativeness? I think it is very important to do this work.”

The CCIA consists of two phases — UG3 and UH3. The current two-year award supports one multi-site trial. However, the study will ultimately involve a total of three clinical trials involving three different conditions and three different treatments across four different geographic locations.

The first trial, funded by the current UG3 phase of the project and taking place at UB and UPenn, is the largest of the three — with 200 participants — and involves smoking cessation. The second trial is focused on depression treatment and will take place at MUSC. The third, involving opioid addiction, will be held at UAB. The second and third trials will occur in the second phase (UH3), and each include 100 participants.

Dissemination of the findings through a web-based toolkit, semiannual webinars and a national conference are also planned. This work will be jointly funded/supported by the UG3/UH3 and MUSC’s HRSA-funded Center of Excellence in Telehealth.

“For all of these studies the research question is the same,” Dahne explains. “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.”

The investigators believe that reducing the barriers that keep people from being able to visit in-person study sites may result in trials that are more representative, and therefore advance health equity for trial participants. Alternatively, as Dahne and Hawk wrote in JAMA in 2023, technological and internet barriers could reduce the representativeness of clinical trials. “Without good data, we just do not know,” Hawk says. “That’s why we are so excited to run these 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 says. “Then they can begin to integrate that information and that evidence into their trial designs going forward.”

“The grant from NCATS will allow us to assess the many beliefs around remote trials,” Hawk adds. “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?”

Participant recruitment is set to begin in early 2025.