Innovation spotlight: Adding nursing support to at-home clinical trials

At AmerisourceBergen, we use our collective expertise to help manufacturer and provider clients deliver patient-centered healthcare. A case in point: Combining Lash Group's best-in-class medication adherence programs with World Courier's industry-leading Direct-to-Patient (DtP) logistics services to offer a comprehensive clinical trial solution that meets the needs of both manufacturers and patients in the United States. Here's how:

Creating value through synergy

The DtP model has revolutionized the clinical trial process by delivering drug therapies directly to patients' homes. Lash Group promotes better patient outcomes through innovative patient engagement and medication adherence programs. Strategically aligning each business' respective strengths means that Lash Group utilizes the reach of World Courier's specialty logistics services. World Courier, in turn, leverages Lash Group's field-based nursing services.

Medical treatments that previously could only be delivered at a trial site or in a limited number of patient homes can now be administered at home in scale, due to the increase in logistics and nursing infrastructure. “This integrated model brings value to both patients and pharmaceutical manufacturers," notes Mike Sweeney, Senior Director, Patient Centric Logistics at World Courier. “Patients have more flexibility in how they access clinical trials, which brings them hope in knowing there may be a realistic treatment path for them. Manufacturers can reach more potential clinical trial participants for recruitment while increasing patient retention and satisfaction."

“Patients have more flexibility in how they access clinical trials, which brings them hope in knowing there may be a realistic treatment path for them."

Keeping patients at the center

World Courier works with homecare nursing providers worldwide to enable more patients to participate in home-based trials.

Understanding and meeting patients where they are is crucial to achieving a patient-centered clinical trial solution. While geography and lack of transportation have always been common barriers to clinical trial participation, the COVID-19 pandemic introduced a new problem: potential exposure to the virus. In fact, 59 percent of patients in a recent study cited exposure risk as a primary reason for choosing not to join a trial. COVID-19 has also been a major disruptor to traditional clinical trials already in progress, forcing pharmaceutical companies to quickly adapt to accommodate participants' needs.

Together, Lash Group and World Courier offer holistic, patient-focused services in the patient's home. “Nationwide, our certified clinicians can go into a patient's home to safely deliver services—whether it be treatment preparation, injection training, lab preparation, or biometric screening—and give the patient the opportunity to continue to participate in the identification of a novel therapy that may improve his or her life," says Dale Hanna, Director of Product Management at Lash Group.

Driving business continuity through disruption

DtP is a customizable solution that can work across therapeutic areas and patient populations. It allows for flexibility in patient scheduling and administration of product at a convenient time.

“We're hearing from a lot of the major pharmaceutical companies that they're looking at our solution longer-term, beyond the COVID-19 situation," Sweeney says. “Sponsors are increasingly designing DtP into their protocols as default to enable the continuity of trials.”

“Over time, as a trial moves through its investigative phases into the post-trial phase, each manufacturer client continues to develop a broad relationship with AmerisourceBergen experts and services — helping them build out their brand as it evolves," adds Hanna.

Finding the right fit

To determine if a DtP clinical trial solution is a good fit, manufacturers should first consider the patient requirements, particularly as relates to increased participation from hard-to-reach demographics. Patient retention and adherence over the course of the trial is also an important consideration.

Treatment at home contains all the inherent variables of launching a clinical trial for a specific therapy, such as temperature control issues, drug administration, and the chance of potential adverse events. The next step is to consider how to manage these variables by utilizing expert logistics and patient support services. Ultimately, keeping the patient at the center of the clinical trial approach is the most important.