By Deborah Borfitz 

February 14, 2023 | Janssen Pharmaceuticals (a Johnson & Johnson company) is customizing the way it conducts clinical trials, utilizing retail clinics on their own or with an affiliate healthcare system as well as mobile clinics stationed outside long-term care facilities in the community. This will enable study teams to choose the model that best suits a trial and participants to “choose the adventure” they most prefer, according to Rachel Soon, director of Janssen Clinical Innovation, speaking on the company’s decentralized approach at last week’s Summit for Clinical Ops Executives in Orlando, Florida. 

Landing on the three clinical trial delivery models took a bit of trial and error, says co-presenter Conor Kane, senior director of Janssen Clinical Innovation, admitting to an “over-eager” start during the early days of the pandemic. The initial idea was to set up traditional sites and give participants the option of having a subset of their assessments performed at a retail clinic. “But that was our thought. We hadn’t actually thought about participants.” 

The team also didn’t consider how the three-way communication between the investigator, patient, and retail clinic would work with the sites, he says. It was difficult to know why participants were choosing a traditional site over a satellite location. 

“Then we ... went the flipside,” Kane continues, with a “high-impact, high complexity” approach that involved finding an affiliate site to administer the investigational product and imaging tests while retail clinics did study management and primary care assessments. It succeeded only in slowing down the retail partner for months. 

This led to a “co-create” trial delivery model where Janssen and its vendors spent more time talking to one another, he says. Given the considerable size of Janssen’s portfolio, vendors were directed to the company’s investor website to view the entire pipeline and read presentations from disease area experts about product strategy. Vendors would then come back to Janssen with ideas about where they would best fit in, and the waters were tested with observational studies and simple assessments. 

Under the newly established, three-model menu, notes Kane, information from vendors is being used to fashion operational plans for studies and get them “close to ready” as early as possible to avoid scrambling later. 

More Options 

Even before the pandemic, Janssen had been developing its decentralized clinical trial capabilities and had a few successes under its belt, says Kane. These included the Heartland Study, in collaboration with Apple, to look at the impact of an app-based heart health program on the early detection of irregular heart rhythms consistent with atrial fibrillation. Janssen also sponsored the fully decentralized CHIEF-HF digital heart failure study. 

When COVID struck, it was necessary to quickly operationalize home healthcare, alternative lab sample collection, and direct-to-patient medicinal product, he continues. But now, Janssen’s focus is to make study protocols flexibly accommodate these decentralized capabilities “wherever it makes sense.”  

People have changed their behavior concerning most everything routinely done at home during the pandemic—including exercising, shopping, eating, and educating, Kane says. “We are not going back to 2019, but we probably don’t know what we want right now, we [just] don’t want that.” It should therefore not be assumed that participating in clinical trials from home will be the exception.  

The mission here is to move trials closer to participants who live away from coastal cities—since 80% of people who would like to participate don’t have access—and to offer some convenience, says Kane. But it is not assumed that home is always the solution. 

Individuals who live in New Jersey should not have to travel to a study site in Boston to access a needed trial. But neither should the definition of a decentralized trial be so narrow as to exclude other means for them to participate, says Soon, in sharing the tale of a friend recently diagnosed with spinocerebellar ataxia (a rare and debilitating neurodegenerative condition) where the home wasn’t a workable option. 

Janssen also recognizes that it needs to keep up with trends evolving in standard healthcare, Soon says. The number of retail clinics has been increasing year over year such that roughly nine out of 10 Americans now live within five miles of a retail pharmacy and, in metro areas, the average distance from their home is less than two miles. 

Similarly, the estimated number of mobile clinics in the U.S. has risen to over 1,000 with collectively more than seven million visits annually, she says. Their primary goal is to increase access to healthcare for underserved populations.  

Hub And Spokes 

The companies operating many of the big retail clinics have detailed roadmaps showing an intended incremental expansion of their capabilities, which includes building out multi-room facilities with privacy and storage as well as the ability to meet the pharmacy requirements needed for a study, says Kane. They’re staffed by nurse practitioners or physician assistants. 

At present, most of these clinics are not ready to run a clinical trial, he adds, but “that stepwise progress is happening.” The retail model has the advantage of being scalable, since there’s a central “hub” location for the principal investigator (PI) and study coordination and many “spoke” clinics where patients could go to participate in a study. The PI could be licensed in a certain state or tri-state area, he adds, although the limitations in this arena have yet to be defined.  

Janssen is looking for “fit-to-find” solutions to transform clinical trial delivery where the target is “a specific geographic area with a defined cohort of patients and a certain set of retail clinics,” says Soon.  “The mobile clinic... is our way of bringing trials out to the community and allowing them to choose.” 

Trials can be customized in any number of ways, including type of vehicle, study design, and the “people resources” going out with the mobile clinic, she continues. The purpose of a mobile clinic can also be customized and the three explored thus far are for patient education and community outreach, to better hit diversity, equity, and inclusion goals; trial awareness and pre-screening, to identify potential new cohorts of patients to recruit; and trial conduct, in terms of the type of facilities where the mobile facilities could go. “We can potentially go to facilities with existing healthcare infrastructure ... [including] long-term care facilities... [or] research-naïve physician clinics, or we could just go to community venues like libraries, churches, carnivals, [and] fairs.” 

Unique Considerations 

Implementation of the current, three-model system comes with challenges, as with any innovation, says Soon. “As we embarked on this journey... we thought, is it [a retail clinic] just a site? Do we need to do anything above and beyond what we would do for a standard clinical site [or] can we just put them through a site selection visit and our SIV [site initiation visit] and call it a day?” 

It is important to delineate all the services that will be expected from the local model and how that differs from a traditional site model, she emphasizes. Likely, this can be reduced to two or three items such as recruitment outside of a standard chart review and perhaps site augmentation or some CRO services. “Focus your qualification efforts on that.” 

A local site may be completely research-naïve, or only partially so by virtue of having a research-experienced PI or staff, notes Soon, and that determines the extent of training by the due diligence team. A fully research-naïve site will need to complete trainings on the full gamut of clinical research topics, including the operational model, roles and responsibilities, and good clinical practices—and these could be sponsor- or vendor-developed or commercially available. “Whatever it is, get it to them on paper, and then translate it from paper into action, so run a simulation of your most complex [scenario] from end to end, [including] data entry, data cleaning, [and] data querying and... [demonstrate] site staff really know how to do this well.” 

Janssen has had a highly experienced PI from an affiliate partner successfully hand-hold a research-naïve PI from a retail clinic, Soon continues. “Remote [PI] oversight has become more accepted with the evolution of decentralized trials and acceleration of clinical trials.” 

The biggest question to arise at Janssen regards the volume of sites, says Soon. The beauty of the local retail model is the ability to quickly scale up by opening a “spoke” site wherever there is a cluster of patients, all under the banner of one overall site. “But how many spokes can a PI really oversee? Some of these retail sites have 200 clinics across the country.” 

Distribution of supplies presents another challenge, Soon adds. “We like to have full control and full oversight of the supply chain from our warehouse right through to a satellite site, [and] that is not possible right now with our IVRS systems.” Until direct shipment to retail sites is internally enabled, investigational products are being sent to a hub for distribution.   

A big upside of the retail clinic model is that review of SOPs, one of the lengthiest parts of the vendor qualification process, is expedited because most of them are site SOPs that don’t require inspection, says Soon. Instead, she suggests a partial review focused on the services that differ from those of traditional sites and doing extra monitoring or embedding performance metrics into clinical trial agreements. Contract templates can also be created to allow contracting with the spoke sites as well as affiliate healthcare providers. 

Janssen’s legal team was particularly concerned about vulnerable populations being served by retail and mobile clinics, she says. Before deploying any of these models, Soon highlights the need to have a comprehensive community engagement and patient engagement plan in place to ensure patients aren’t signing up because they “just don’t know any better.”