Janssen Pharmaceuticals: Solving Clinical Trial Democratization Issues the 21st Century Way

Janssen Pharmaceuticals, a Johnson & Johnson company, has developed three clinical trial delivery models that utilize retail clinics and mobile clinics stationed outside long-term care facilities in the community. These models enable study teams to choose the best trial delivery model for their needs and give participants options to choose the adventure they prefer. Janssen is customizing the way it conducts clinical trials to move them closer to participants living away from coastal cities and offer convenience. The Heartline^TM Study collaboration with Apple and Canagliflozin: Impact on Health Status, Quality of Life and Functional Status in Heart Failure (CHIEF-HF) digital heart failure study are examples of Janssen’s success with decentralized clinical trial capabilities. The retail model is scalable, with a central hub location for the principal investigator and study coordination, and many spoke clinics where patients can participate.

Clinical Status Quo

Janssen’s Clinical Innovation director, Rachel Soon, spoke about the company’s decentralized approach at the Summit for Clinical Ops Executives (SCOPE) in Orlando, Florida. Co-presenter Conor Kane, senior director of Janssen Clinical Innovation, admitted to an “over-eager” start during the early days of the pandemic when 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. Kane says they didn’t consider how the three-way communication between the investigator, patient, and retail clinic would work with the sites, making it difficult to know why participants were choosing a traditional site over a satellite location.

Onward with Project Convenience

Janssen’s mission is to move trials closer to participants who live away from coastal cities and to offer some convenience. The number of retail clinics and mobile clinics in the US has been increasing year over year, with nine out of ten Americans living within five miles of a retail pharmacy. However, most retail clinics are not ready to run a clinical trial yet. Janssen is looking for fit-to-find solutions to transform clinical trial delivery that can accommodate a specific geographic area with a defined cohort of patients and a certain set of retail clinics.

Janssen recognizes the need to keep up with trends in standard healthcare. The estimated number of mobile clinics in the US has risen to over 1,000, with collectively more than seven million visits annually. Their primary goal is to increase access to healthcare for underserved populations. Janssen is customizing clinical trial delivery models to keep up with these trends.

Janssen is focusing on making study protocols flexibly accommodate decentralized capabilities wherever it makes sense. The mission is not to assume that home is always the solution, and individuals who live in a certain geographic location should not have to travel to a study site far away to access a needed trial.

Comparison Is Needed for Betterment

According to Soon, the implementation of the current, three-model system has its challenges, like any innovation. When the company embarked on this journey, they had to consider whether a retail clinic was just a site or whether they needed to do something more than what they would do for a standard clinical site. They needed to define all the services that would be expected from the local model and how that differs from a traditional site model.

A local site may be completely research-naïve or only partially so, depending on whether it has a research-experienced PI or staff. This determines the extent of training required by the due diligence team. A fully research-naïve site will need to complete training on the full gamut of clinical research topics, including the operational model, roles and responsibilities, and good clinical practices. Janssen has had a highly experienced PI from an affiliate partner successfully hand-hold a research-naïve principal (PI) from a retail clinic.

Addressing Issues on Logistics and Control

The biggest question to arise at Janssen is regarding the volume of sites. 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. However, some retail sites have 200 clinics across the country, and it is unclear how many spokes a PI can oversee.

Distribution of supplies also presents a challenge. Until direct shipment to retail sites is internally enabled, investigational products are being sent to a hub for distribution. The review of SOPs is expedited with the retail clinic model because most of them are site SOPs that don’t require inspection. Instead, a partial review focused on the services that differ from those of traditional sites is suggested.

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

Engr. Dex Marco Tiu Guibelondo, BS Pharm, RPh, BS CpE

Editor-in-Chief, PharmaFEATURES