Mobile Trial Vans, Research Paramedics and More Featured in WCG Innovation Challenge
The 2024 MAGI Clinical Research Conference in New Orleans played host to yet another exciting round of clinical trial innovation, with attendees voting on their favorite of five creative approaches in the WCG Innovation Challenge. Read on to learn more about this year’s winner as well as the four finalists.
Winner – Research Works
Research Works, an integrated research organization headquartered in New Orleans, was crowned the winner of the WCG Innovation Challenge for its use of a converted Mercedes Sprinter van as a clinical trial on wheels.
Three years after taking on irritable bowel syndrome trials in 2017 and encountering serious challenges in bringing participants to the site, Research Works began considering decentralization and virtual home visits as potential solutions.
Kaye Doiron, founder and CEO, came up with a bold and innovative idea that year: purchase a Mercedes Sprinter van and turn it into a comprehensive trial vehicle that serves “basically [as] an annex of the research site,” she told The CenterWatch Monthly.
“The ‘hub and spoke’ model for us is a failing model alone. It’s exponentially costly to build and a beast of a burden to manage,” Doiron told conference attendees. “[Our van] brings the clinical trial site directly to the patient at home as a standup pop-up site or seamlessly integrated into medical practice.”
“It depends on the target population you’re going after and how creative you want to be with your marketing scheme,” Doiron said. “We recently ran an STD study and it was a huge impact to be able to go park on Sorority Row or a college campus to get young people to come and read about our study.”
The van serves as a full pharmacy and laboratory on wheels, equipped with everything Research Works needs to conduct trials: a refrigerator and medical freezers; an ambient cabinet; an intravenous infusion chair and accompanying cardiac equipment; rescue equipment; and an EKG machine. It’s also equipped with curtains for blinding and unblinding patients.
Its mobility gives it prime access to community happenings, such as church gatherings, festivals, concerts and university events, among many others. When not on the road, it plugs into Research Works’ home base to serve as an extra room. The hybrid-engine vehicle runs up to 40 hours idling, 12 to 14 hours on battery backup and nonstop when plugged into a standard wall outlet.
The van also solves a state-specific problem – a growing number of physicians being barred contractually from running trials for outside research companies within their practices, according to Doiron. The van being its own separate unit makes it easy for physicians to conduct trials outside of their buildings without fear of violating their contracts.
Doiron’s innovation didn’t come together overnight. Designing the mobile trial van was a challenging endeavor, particularly when it came to the tighter confines of the van and the power needed to run all the trial equipment. Months of working with an engineering team were necessary to make her vision a sufficiently powered reality. Thankfully, the head of the team was an EMT accustomed to administering care in small spaces, and chair-related challenges were mostly solved through the use of a tattoo chair that can be laid flat for chest compressions, though Doiron intends to obtain a smaller chair in the future.
“Space was a big issue to really design a space where I can do an IV, manage cardiac responses, push rescue meds, get my staff around the chair to do chest compressions and defib. There was a lot of work that went into designing that space,” Doiron pointed out. “The other [issue] was the power – getting the hybrid engine to be able to run a 70-below refrigerator, a 20-below refrigerator and an ambient cabinet. We don’t ever turn this unit off.”
It wasn’t cheap, either, with the bill coming out to approximately three brick-and-mortar satellite sites with lab and pharmacy capabilities – nearly $195,000. But the payoff has been massive, Doiron says, and she urges those interested in crafting their own trial van not to be deterred by the initial costs. A comparator study conducted with three satellite sites, for example, showed that Research Works’ mobile van boosted their patient database by 900 percent, and use of the van in a high-volume vaccine trial saw more than double the number of total consents compared to the traditional site.
“It is reliable, profitable, replicable and fully customizable for your sponsors’ needs,” she said. “As just an owner/founder with no outside capital, it took me four years to actualize it and realize it, but I was so motivated to get it built because I do feel it has limitless potential in many, many applications, not just conducting clinical trial research visits.”
Doiron, who has plans to expand with more customized units, says she did face some pushback from skeptical sponsors, and she asks that sponsors have a more open mind when it comes to innovative approaches. Regulatory agencies, on the other hand, have been most excited about the van.
“Sponsors can’t keep up with innovations fast enough to change their standard operating procedures or even think outside the box,” she told The CenterWatch Monthly. “They need to be quicker to pivot for innovations that are coming in our industry.”
Finalists
Four other finalists made it into the WCG Innovation Challenge and presented in New Orleans:
- Wake Forest University School of Medicine, which countered staffing challenges with the use of research paramedics. Lauren Koehler, research manager, and Kylee Smith, research coordinator, explained how research paramedics possess skillsets well-suited to clinical research, including trust-building with patients and strong communication skills that enable them to talk to anyone. Koehler advises sites interested in this staffing model to check state requirements, as practice plans in some states don’t allow the use of paramedics, and work with EMS leadership and paramedic programs to begin a conversation.
- Erie Retina Research, whose innovative community clinic model not only boosts diversity and minimizes pretrial screening failures but also strengthens and invests in the surrounding community through thoughtful partnerships. Erie’s director of clinical research, David Almeida, detailed how the site’s work with food banks, schools, nonprofits and others to provide access to trials and standard-of-care assessments is centered on leaving the community better than when they arrived. The program has led to significant growth in screenings, enrollments and trial workload since its inception in 2021. This growth has been maintained through the use of an in-house risk management team comprised of a former FDA auditor, a chief monitor and a chief compliance officer that conducts random trial quality assessments on a monthly basis.
- Cedar Health Research, a site network that uses innovative diversity strategies to integrate with community physician practices and ease the burdens of getting into clinical research. CEO Todd Albin told attendees how Cedar deploys an AI/machine learning solution that integrates with electronic health records to match patients to trials, helping sponsors significantly increase the diversity of their trial populations. The company pairs this with a healthcare partnership team that works one-on-one with physician practices to educate and inform them on clinical trials, as well as external marketing campaigns and community collaborations.
- Louisiana State University Health New Orleans, whose virtual oncology platform has successfully extended trial access, improved adherence to trial procedures and eased travel burdens for female patients in rural areas of the state. Amelia Jernigan, division director of gynecology oncology at LSU Health New Orleans School of Medicine, shared how she and her team used a multidiscipline, tablet-powered survivorship care program already in place to launch a new program that connects travel-averse patients to trials. Through this effort, they have successfully enrolled patients who normally would have declined surgical oncology trials with follow up procedures that can be done locally.
To listen to recordings of MAGI 2024 sessions, click here.
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