COVID-19 continues to impact every level of clinical research, leaving trial professionals and their partners to seek solutions that help them move forward, increase patient eccentricity, and do their jobs better. Even before the pandemic, studies were moving toward increasing decentralized trials, but the model has soared since the virus first struck.
Outsourcing-Pharma spoke to two professionals focused on direct-to-patient trial solutions:
- Andrea Zobel, senior director of personalized supply chain at World Courier
- Dale Hanna, product director for adherence services at Lash Group
The two leaders spoke about the increase in decentralized trials, logistics challenged, and how solutions like home health services can contribute to keeping trials going.
OSP: Could you please share your perspective on how the clinical trial industry, and its logistics/supply chain needs and concerns, have evolved in recent years (leading up to COVID-19’s arrival)?
AZ: Over the last five years, we’ve seen an increase in the use of the direct-to-patient clinical trial model. When we started providing direct-to-patient shipments about a decade ago, only a few sponsors incorporated the decentralized model in their trial design. In 2020, we delivered to patients in their homes in 75 countries as part of our direct-to-patient logistics service.
The impact of COVID-19 has accelerated the uptake of this model, but even pre-pandemic the growth in at-home trials reflects the industry’s increased focus on patient-centricity. Direct-to-patient logistics, which brings therapies and customized care directly to patients’ homes, helps to boost patient recruitment and retention—two barriers that can derail clinical research studies.
More importantly, this approach expands the patient population pool, including hard-to-reach demographics, people who have mobility issues or cannot integrate the visits into their everyday life.
Despite the growing use of this approach from 2010 to 2019, large-scale feasibility wasn’t proven. Prior to the pandemic, the model had mostly been applied to small studies in the United States and Europe.
OSP: How has your company come up with solutions to help clinical trial and pharma firms meet those challenges (pre-COVID)?
AZ: We have always focused on our footprint and service offerings, to ensure the right solutions are available. We are continually expanding our network across more strategic locations and increasing our owned offices globally. Our knowledge of international regulatory requirements, coupled with our temperature-control solutions and logistics expertise, enables us to deliver time- and temperature-sensitive medical products to patients’ homes across the world—all while complying with GxP standards and with local regulations.
The direct-to-patient approach requires pick-ups and deliveries to be made within a predetermined, often extremely narrow, timeframe in close cooperation with the investigators and clinical site staff. As such, it’s critical for logistics partners to collaborate with stakeholders across the supply chain and leverage technology solutions that can provide real-time visibility, while maintaining patient confidentiality.
We work closely with home care nursing providers, including the team of field-based nurses at Lash Group, to coordinate deliveries and enable more patients to participate in home-based clinical trials.
DH: Nursing support is integral to the successful design and execution of an at-home clinical trial. While their role varies based on the specific therapy, the at-home support nurses provide has been a key driver behind the expanded list of therapies suitable for this approach.
For example, at Lash Group, 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. Driving patient access and adherence is at the core of what we do.
Through these at-home services, our field-based nursing teams help instill confidence in patients and prepare them to manage more complex medication regimens.
When trial activity is moved from a healthcare setting into patients’ homes, it’s also critical to incorporate remote monitoring and engagement solutions to increase connectivity with patients and help address any barriers they may face.
During the COVID-19 pandemic, we’ve found that patients have quickly adapted to using technology, like online platforms and mobile engagement tools, to connect with different stakeholders, including patient support providers. To monitor and stay connected with patients, we deploy mobile healthcare solutions that provide personalized dosing or injection reminders, tracking measures, and education about the therapy regimen.
The dynamic technology solutions, coupled with the support and guidance from our team of nurses, help to improve adherence and the patient experience.
OSP: Dealing with the pandemic has required folks in the clinical research and drug development field to get pretty creative. Could you please talk about how they’ve shifted their work to keep going in the face of COVID-19?
AZ: Zobel: During the past year, as many as 80% of non-COVID clinical trials were paused, as countries worldwide imposed travel restrictions and stay-at-home orders and hospitals navigated limited capacity.
To resume, or launch new clinical trials, many sponsors amended their trial design to include direct-to-patient delivery. In a survey, 73% of respondents said they increased their use of decentralized trials amid the COVID-19 pandemic.
The shift of clinical trial activity into patients’ homes requires collaboration among all stakeholders, including logistics providers like World Courier. This is to ensure all clinical study materials, including temperature-sensitive products, arrive at the patient’s home in the right condition, and at the same time as the nurse if there is home healthcare included; additionally, time and temperature sensitive biologic samples must be collected from patients’ homes and sent to the laboratory for analysis.
OSP: How have companies like World Courier and Lash Group worked to help clinical trial clients deal with this brave new world? Specifically, how have you helped with services that meet the surge in DTP services, and the rising preferences for decentralized/hybrid studies?
AZ: We’ve always worked closely with manufacturers and trial sponsors on the set-up of decentralized trials, but new to us during the pandemic has been transitioning existing traditional trials into the patients’ home. By May 2020, our daily volume of direct-to-patient shipments was more than 5x our pre-pandemic average. As the volume increased, we developed a cross-regional triage group to ensure we could continue to deliver high-quality logistics services at what was an unprecedented scale.
Travel restrictions can significantly lengthen the time it takes to deliver shipments – this was particularly evident in the Spring of 2020 but continues as countries experience subsequent waves of the pandemic. To navigate these potential delays while still meeting the country-specific regulations, our teams identify alternative routes that enable us to expedite product movement.
Ultimately, through close collaboration with all stakeholders, we’ve been able to meet the heightened demand for direct-to-patient services and ensure patients continue to access the medication they need.
DH: The expanded use of decentralized clinical trials requires increased nursing support and medication adherence services. With patients participating 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 injected.
Our telehealth and field-based nursing teams meet patients where they are to deliver a wide range of services, such as in-home, on-site, and virtual injection and administration training. Through virtual training, we 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.
Our teams also leverage mobile engagement tools and multichannel communication, like text alerts, to provide real-time, personalized interventions based on patient behavior to drive adherence. Ultimately, the nursing support and technology-enabled adherence solutions help to improve patient outcomes and their overall experience.
OSP: How can sites and sponsors craft an effective, efficient logistics strategy in the face of the evolving industry—what sorts of questions do they have to answer?
AZ: It’s critical for trial sponsors to work with a logistics partner that can help them navigate local regulations and restrictions and execute the delivery of direct-to-patient services across multiple countries. As recently as July 2020, trial sponsors cited regulatory acceptance as the biggest challenge to overcome for running decentralized clinical trials.
Prior to the pandemic, there were questions about execution of a decentralized model, including whether treatment could be delivered within temperature range in a timeframe consistent with dosing regimens under oversight of the respective investigator, or whether nurses could be reliably arranged to maintain dosing schedules and execute the study specific documentation. Now that there is more evidence showing the efficacy and feasibility of the model, regulators are increasingly comfortable with this approach.
To achieve the best outcomes, it’s important for sponsors to seek a logistics partner that can advise on best practices for designing a decentralized trial, including deciding whether to draw stock from a site pharmacy or in which countries or for which studies it is possible to use a central pharmacy model. In many cases, a successful trial requires close connectivity between the logistics partner and nursing support, as the product and nurse must arrive at the patient’s home at the same time.
Logistics partners that have experience working in collaboration with field-based nurses can help reduce any potential barriers and ensure deliveries are timed precisely to coincide with the patient’s availability and nurse’s home visit. Given today’s fast-changing healthcare landscape, trial sponsors and their logistics partner need to develop a robust contingency plan that allows teams to mobilize quickly, if needed, to take corrective measures.
OSP: Do you have anything you’d like to add about your company, DTP solutions, etc.?
AZ: We anticipate decentralized trials to be a feature of clinical trial designs going forward. As this model has grown more prevalent over the last 14 months, we’ve found that it’s no longer an emerging solution—it’s proven to be a viable model to practice at scale, including in markets beyond the United States and Europe.
In fact, based on a recent survey of our manufacturer partners, 76% of respondents say they plan to offer a direct-to-patient trial design moving forward. We are very confident that guidance for decentralized clinical trials in the current emergency regulations, e.g. from FDA and EMA, will be implemented permanently.
The success of these trials will depend, in part, on the logistics strategy. The successful delivery of specialty pharmaceutical products requires temperature-control packaging solutions and precise coordination across the supply chain—including logistics and technology partners, home healthcare providers, clinical sites, and the patients themselves—to ensure that medication is received on time, in the right condition.