By Deborah Borfitz 

July 19, 2021 | A startup is positioning itself to be a key player in the burgeoning decentralized clinical trial (DCT) marketplace and has tapped industry innovator Craig Lipset, who designed and co-led the industry’s first fully virtual clinical trial, to be its executive advisor. MedVector is the first company to enable local, non-investigative physicians to access clinical trial medications as a care alternative, according to CEO Scott Stout. 

The newly launched Prime-Control Technology is the critical but less interesting part of the story, says Stout, a former professional investor who co-founded MedVector in 2017. A portable telemedicine device, it serves as a physical window connecting patients in the office of their primary care physician to a principal investigator (PI) at a clinical trial site. The PI still runs the trial and carries out all elements of the protocol as if the patients were physically in the same room. 

This “MedVector window,” as it is otherwise known, eliminates the three main barriers to physicians recommending clinical studies to their patients: not wanting to refer patients away, lack of compensation for performing protocol-related services, and disinterest in becoming a PI themselves, says COO and Co-founder Ted Barduson. Patients might thereby be more often advised by their trusted doctor to get involved with a trial, and without ever having to step foot outside of the familiar practice setting. 

“The way to be truly patient-centric is to include the doctor,” says Stout, “and that is a key challenge where the industry has never before had meaningful solutions.” The MedVector concept is to align all the players—pharmaceutical companies, contract research organizations (CROs), patient recruitment companies, principal investigators, and local clinical practices and their patients. “This is kind of like a quick fix to the existing model, unlocking access to millions of potential clinical trial candidates that are otherwise trapped behind non-referring physicians.” 

MedVector is “currently working with five pharma companies and five CROs and evaluating several protocols to determine which is the best fit for a launch study,” Stout says. The model is appropriate for self-administered, non-procedural medications (i.e., pills, creams, drops, self-injectables, inhalers, and sprays) that describe about 95% of all top-selling medications. 

Eventually, MedVector may partner with infusion centers to broaden its reach to studies of chemotherapies and other infused medications, he adds. 

Starting Point 

Broadening access to study participants without adding new clinical trial sites was an idea born of serendipity. It was 2017 and Stout was meeting with two clients, one a private equity firm that bought hospitals and the other data analytics company Verras, when he learned the long list of reasons hospitals often did not run clinical trials—including not knowing how, who to hire, what was in the pipeline, and whether their patients stood to benefit. 

Hospitals also recognized they could collect referral fees by sending patients to facilities that were doing clinical research, he adds. They just did not want to risk losing their customers.

Thinking quickly on his feet, Stout proposed seeking out a turnkey clinical trial company that would profit-share with hospitals in exchange for access to their patients and leave when the study ended. “It turns out that didn’t exist,” he says. Elligo Health Research, founded in 2016 to provide physicians with the infrastructure to conduct trials (and subsequently acquiring ePatientFinder technology to bolster its trial matching process), was the closest offering on the market but was relatively unknown as the time. 

Why be on the ground at all, Stout recalls thinking, with this “new thing” called telemedicine ready for prime time? Lab and imaging data is also digital, opening the possibility of trial participation from pretty much anywhere.

With that in mind, he scheduled a conference call with Jamey Edwards, CEO of telehealth provider Cloudbreak, intending to ask for an introduction to its clinical trial partner. But, once again, no such company existed. 

With a show of support from everyone in the room—the private equity investor, Verras Founder and Chairman Dennis J. Patterson (the third co-founder of MedVector), and Edwards—Stout vowed to build what they could not find. MedVector was born. 

‘Impossible Matrix’

Hospitals were not alone in their concern about losing patients if they started referring them out for clinical trials, says Stout. So, too, were primary care and specialty physicians. 

Additionally, “doctors doing clinical research are perceived to be better than nearby peers not engaged in studies,” he adds, “prompting some hospitals to sponsor a few trials as a kind of ‘loss leader’ to build their brand image in the community. Outside of industry, most people are unaware that studies are generally done at dedicated clinical trial sites with a carefully guarded candidate pool courted with advertising and media campaigns often producing minimal enrollments.” 

Medical innovation over the past few decades has also become more targeted, with multiple companies chasing the same discoveries and use cases, Stout continues. That has left a relatively shallow pool of potential participants for any one clinical study. 

The traditional tactics of patient recruitment firms result in a 1% to 3% conversion rate of patients into studies, says Stout, compared to better than 35% among doctors who are hosting clinical trials. Research also suggests that over 70% of patients are willing to try a clinical trial if it is being offered by their local physician.

“So, there’s this disconnect where patients want to hear about [trials] from their doctor but doctors don’t have the bandwidth to understand all 380,000 clinical studies that are on the market at any given moment, let alone which ones are geographically convenient to their patients,” Stout says. “It just becomes an impossible matrix.”

Aligning Incentives

The MedVector model engages the existing patient base of physicians as a team effort with the CRO running a trial and its existing principal investigators and clinical trial sites who know the local doctors, says Barduson. CROs are currently being forced to activate more sites due to poor participant enrollment, which is expensive—the startup process can run between $75,000 and $100,000 per location—and often unproductive. Research suggests 11% of all active clinical trial sites never find a single patient. 

If physicians have no more than two or three potentially qualified patients for a study, the volume is also too low to justify all the logistics involved with becoming a PI, says Stout. “Local doctors are not worried about the revenue; for the most part, they want to provide the best care for their patients and just like everyone else they are afraid of the unknown, which is why they don’t refer away [patients to established trial sites].” 

Clinical trial candidates are not “medical mysteries,” Stout adds. “They typically have an existing diagnosis, are typically on an existing medication, and typically have a trusted relationship with a local care provider. So, we know where they are… and access comes through [their] doctor.” 

As envisioned by MedVector, local nurses could draw blood, measure vital signs, and perform other generic study-related procedures under the supervision and delegated authority of the PI, he says. The PI would enter all clinical data, adhering precisely to the same protocols for all appointments, and maintaining the same good clinical practice as a traditional clinical trial appointment. 

“MedVector is not looking to run the trial or recruit patients,” Barduson stresses. “Our business model is additive to the existing process. Pharma, CROs, and recruitment companies [all] say that patient recruitment and patient retention is their number one issue, followed closely by the inability to reach a diverse population. All we are looking to do is align the incentives with local doctors so we can unlock [their patient base]… to accelerate clinical trial timelines.”

Pharmaceutical companies are highly motivated to get to market as quickly as possible because the clock starts ticking on their 20-year medical patents during the typical 10-to-14-year journey to market, says Barduson. For perspective, the value of the patent on the arthritis drug Humira was $1.8 billion per month last he checked.

The Prime-Control Technology can be shuffled around to the practices as needed since the device is portable and there is typically a 30-day stretch between study visits, says Barduson. MedVector expects a single device to be used for about three to five virtual study visits per location and that 40 of the devices will be sufficient to handle more than 20,000 visits per year at scale.

By having patients physically push a button on the device rather than click a link in their email, the technology “knows where it is and why it’s there,” adds Stout. “This eliminates the need for passwords, reduces user error, and eliminates the variability found within the BYOD [bring your own device] model.  Participants literally hold the window into the clinical trial site, enabling a face-to-face interaction with the investigator team.” 

Phased Launch

MedVector’s Prime-Control Technology could theoretically be used for DCTs conducted in people’s home, says Stout, but the beauty of connecting patients to PIs from local practices is that they are more likely to tell their friends about the trial they are in. Physicians become educated about the study, which could prompt introductions to yet more potential participants. “This concept also lays the foundation for pharma to have an early relationship with a potential prescribing physician.

“Going direct to the home seems patient-centric but it can actually be counterproductive and intrusive,” he adds. Many people would prefer to go to a trial than have the trial come to them. 

“We are the easiest first step to the decentralized clinical trial marketplace … [because] you don’t have to design something around the patient being at home,” Stout says. “MedVector works within the existing protocol; principal investigators can continue to observe patients as walk-ins and increase their volumes by also observing patients [virtually] using MedVector.” 

The company is “trying to play nice with everybody,” he notes. This includes the possibility of working with decentralized clinical trial providers such as Medable or Science 37 and embedding their technology into the MedVector window.

The company is launching in phases, says Stout, the first one having two parts—working with patient recruitment companies to expand geographic footprints and connect already identified candidates that live far away from study sites as well as feasibility departments connecting candidates from unselected sites and protecting CROs from the expense of activating new sites.  

During the second phase of the launch, MedVector will be activating specialty physicians. “Specialists typically believe in advanced medicine, but practice logistics make participating in clinical trials challenging,” says Stout. “However, when specialists can offer all of the benefits of a clinical trial as a care alternative without the disruption, it creates a complement to the practice.”

The third component of MedVector is its partner network, Stout adds. In another few years, the company plans to be collaborating with payers, countries, and hospital networks with large patient databases to identify and connect patients to existing clinical trial sites.

MedVector has already partnered with seven hospitals with great success, says Stout. “Once we prove out the MedVector window and our Prime-Control Technology, the sky’s the limit.”