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The success of the decentralized model hinges on coordination between stakeholders across the supply chain to ensure that date is secure, medication is delivered on time, and in proper condition.
More patients worldwide are participating in clinical trials from their homes than ever before. The use of the decentralized study model—which climbed steadily over the last five years—has skyrocketed globally since the onset of the COVID-19 pandemic, as sponsors adapted trial designs to maintain continuity amid overloaded hospitals and stay-at-home orders. It’s clear that this approach is no longer an emerging solution—it’s a viable model to practice at scale. Success will depend, in part, on the logistics solutions in place to support manufacturers manage regulatory requirements, patient privacy and the delivery of time- and temperature-sensitive products.
The decentralized model has transformed the clinical trial process by offering an alternative approach that can help improve patient recruitment and retention. By bringing therapies and customized care directly into homes, sponsors can expand access to a broader and more diverse range of patients, including those who otherwise wouldn’t have been able to participate due to location, lack of transport or mobility issues.
While it offers significant value to manufacturers and patients, the successful execution of the direct-to-patient model requires a heightened level of coordination across the supply chain. Sponsors need to identify logistics partners who can support delivery across the world within a predetermined, extremely narrow timeframe—often timed to the arrival of a home healthcare provider. Given the complex nature of specialty pharmaceutical products, the shipments require temperature-control packaging solutions and precise coordination to ensure the medication—or biologic sample being picked up—is delivered on time and in the right condition.
Prior to the pandemic, the decentralized model had been mostly confined to small studies in the United States and Europe, so large-scale feasibility hadn’t been proven. But, as the volume of direct-to-shipments increased last year, it became clear that more widespread use of this model is feasible and effective. At the same time, regulators worldwide implemented new guidance to enable flexibility within trial protocols—removing barriers that often curtailed the use of decentralized trials. In fact, as of July 2020, trial sponsors cited regulatory acceptance as the biggest challenge to overcome for running these trials. Looking ahead, we anticipate more broad regulatory acceptance. Still, it’s critical for sponsors to work with a partner that can help them navigate local regulations and restrictions and execute direct-to-patient services across multiple countries.
As more patients participate in clinical trials from their homes, it’s critical to ensure they have the resources needed to manage a complex therapy regimen, particularly if it’s a specialty pharmaceutical product that needs to be administered. Home healthcare support and medication adherence services are integral to the successful execution of an at-home clinical trial. Certified clinicians offer a wide range of home-based support, from treatment and lab preparation to injection training or biometric screening. Through a blend of at-home services and virtual training programs, the clinical staff helps to empower patients to take a more active role in their healthcare journey and make sure they have the education needed to remain compliant with their medication regimen.
Remote monitoring and mobile engagement solutions help to increase connectivity with patients and enable teams to anticipate issues that could affect adherence. For example, our teams at Lash Group leverage mobile engagement tools and multichannel communication, like text alerts, to provide real-time, personalized interventions based on patient behavior to drive adherence. Solutions that provide personalized dosing or injection reminders, tracking measures, and education about the therapy regimen can help teams monitor and stay connected with patients.
The shift of activity into patients’ homes also introduces new considerations around data privacy and patient confidentiality. As such, sponsors need to work with their logistics partners early in the process to determine how patients’ data will be captured, stored and protected. Teams should develop robust, well-communicated safeguards to ensure the exchange of private information is strictly monitored. For example, at World Courier, we limit access to only those directly involved in delivering to the patient, such as drivers and dispatchers, and the customer service teams coordinating the activity.
Technology can play a vital role in protecting patients’ information. Sponsors and their partners should deploy digital solutions that can anonymize patient information while also ensuring data can be attributed to a consistent ‘patient ID,’ so it remains comprehensible to centralized trial sites.
In addition to complying with local data regulations, sponsors and their partners need to be aware of the General Data Protection Regulation (GDPR) as well as health-specific regulations, such as the Health Insurance Portability and Accountability Act (HIPAA). When combined with the challenges of transport and customs clearance protocols, it’s clear that a complicated balancing act is required. Sponsors should look to work with a provider that has the expertise needed to navigate these challenges, all while protecting patient privacy and confidentiality and delivering the products on time.
The COVID-19 pandemic has acted as a catalyst for change within the clinical trial landscape, expediting the broader implementation of the direct-to-patient model. Given the recruitment, retention, and economic benefits of the approach, we anticipate decentralized trials to be a feature of clinical trial designs in the future. In fact, based on a recent survey of our manufacturer partners, 76% say they plan to offer a direct-to-patient trial design moving forward.
Ultimately, the model’s success hinges on precise coordination between stakeholders across the supply chain—including logistics and technology partners, home healthcare providers, sponsors, and the patients themselves—to ensure that data is protected, and medication is delivered on time, in the right condition, with the right support.
Andrea Zobel is the Senior Director of Personalized Supply Chain at World Courier, and Dale Hanna is the Product Director of Adherence Services at Lash Group, both a part of AmerisourceBergen