Adoption of the decentralized clinical trial (DCT) model surged during the COVID-19 pandemic. Now that the virus is showing signs of releasing its grip on the globe, sites and sponsors are weighing the long list of reasons why continuing with virtual trials, rather than bringing all their sites back online, could benefit their work as well as the patients at the center.
Chris Armstrong, president of clinical trials business for Thermo Fisher Scientific, spoke with Outsourcing-Pharma about his company’s direct-to-patient solutions, and why these resources are a good idea for stakeholders all along the study pipeline.
OSP: Please tell us your views of how clinical research professionals’ understanding and adoption of decentralized and hybrid trial technology have changed in recent years.
CA: The traditional clinical trial model doesn’t account for the many obstacles patients face when partaking in a clinical trial. Several hurdles are often overlooked, including the time and money patients spend traveling to the clinical site and taking time off from work. Patients want their personal sacrifices to be considered when studies are designed and are reluctant to sign up for trials that aren’t convenient to their location, schedule, or lifestyle.
As a result, many clinical sites are under enrolling or have a high dropout rate that negatively impacts the study duration and costs, and potentially delaying the time to market for novel therapies. Delivering medication directly to patient homes and offering the patient’s the option to choose between traditional clinical trial visits, hybrid trials, or 100% virtual trials eliminates many of these pain points.
COVID-19 posed additional challenges to clinical trials and sponsors were forced to pivot their plans and adopt direct-to-patient (DTP) emergency shipments in order to avoid leaving patients without medication. As more clinical trials become decentralized, there is an increasing demand for supply chain flexibility and digital patient support capabilities.
OSP: Similarly, how have the array of decentralized services and technologies evolved?
CA: The traditional clinical trial industry is behind the commercial supply chain in some areas by about 10 years in terms of technological advancement. This is evident in the recent popularity of home delivery pharmacy-to-patient services and virtual patient visits that are only now becoming increasingly used for clinical trials.
Digital informed consent has existed for years and now digital patient recruitment and screening at home are becoming popular methods of trial enrollment. Today, virtual trials are supported by these systems and processes, including Thermo Fisher’s DTP offering.
Additionally, many large pharmaceutical companies have taken to cross-fertilizing their businesses by translating system use across departments. For instance, many organizations are now implementing cloud-based temperature monitoring used in commercial activities and in clinical trials as well.
These cloud-based systems correlate nicely with the ability to monitor results from mobile devices, such as GPS-enabled temperature monitors, easing restrictions on the location of participating patients and practitioners.
OSP: Could you please share the evolution of Thermo Fisher Scientific DTP offerings—how has the roster of solutions grown, changed, and evolved in recent years; and what are the key new additions behind this announcement?
CA: Thermo Fisher’s DTP offerings date back to 1996 when the company established a pharmacy-to-patient service from its pharmacy in Rockville, Maryland. Over the past 25 years, Thermo Fisher has used the pharmacy to ship medication to patients’ homes to support other patient-focused programs, such as Free Goods Program (a program for patients in the US who are not able to afford medication) and compassionate use. In recent years, the DTP service has been expanded to meet the needs of clinical trials, with Clinical Site-to-Patient shipments first sought for emergency use as a response to natural disasters.
In 2020, Thermo Fisher expanded its suite of DTP services. Our clinical site-to-patient service now supports distribution in 47 countries. We also established a depot-to-patient service in the US: this expanded program can support any trial phase and a range of trial variables including any interactive response technology (IRT) systems, blinded/unblinded studies for almost any clinical trial drug type.
Through the DTP solutions, Thermo Fisher provides expertise across the full supply chain, including support for ancillary sourcing, blinding, patient kit production, clinical supply optimization, and decentralized clinical trial setups. The program also utilizes Thermo Fisher's Total Transportation Management capabilities, reassuring sponsors that the best courier to deliver to both patients’ homes and study sites is selected.
Delivering medications directly to patients' homes or the study sites enables maximum patient compliance. For patients participating in hybrid or virtual trials, Thermo Fisher provides additional services such as coordination with home nurses. DTP also offers end-to-end cold chain management and traceability and centralized storage of clinical trial material, reducing waste and minimizing the storage space needed at clinical sites.
OSP: How has patient engagement, and site/sponsor attitudes toward the importance of patient-centric trial design, evolved?
CA: Decentralized clinical trials have been on the rise even before the COVID-19 pandemic. In many cases of ongoing hybrid trials, patients have been receiving telemedicine visits and medication at home. The patient feedback from this practice has been positive, resulting in patients reaching out to the clinical trial sponsors asking for a continued supply to their homes.
From a sponsor’s perspective, decentralized trials enable faster patient enrollment and higher retention rates. Clinical sites see the patient burden every day especially when caregivers and patients are required to regularly travel the distance between the patient’s home and the clinical site.
Sponsors have also recognized the value of patient centricity. It is now understood that a decentralized clinical trial has the potential to significantly reduce the trial lengths and therefore has influenced many sponsors to engage home nurse visits to further decrease the burden on the patients.
OSP: How has the COVID-19 pandemic changed the overall clinical trial industry?
CA: COVID-19 has accelerated the adoption of decentralized clinical trials due to travel restrictions and patients’ reluctance to leave their house and surround themselves with other people. The number of decentralized clinical trials tripled from 2015 to 2019 and is expected to grow at an accelerated pace due to COVID-19.
In the wake of the coronavirus pandemic, many sponsors had to ship medication to patients in order to avoid missed dosages. Since then, Contract Research Organizations are now seeing patients request to continue to receive medication at home after the pandemic because of its convenience. As a result, sponsors are looking intensively into DTP shipments and supporting services.
OSP: How do you think DTP services (at your company and industry-wide) might change in the future?
CA: Looking at the future of DTP services, there will be an enhanced digital aspect to these offerings that will further increase the effectiveness of decentralized clinical trials. Digital technologies will include real-time shipment monitoring as well as novel approaches to improve data connectivity across the clinical trials ecosystem.
The industry is unlikely to revert back to traditional clinical trial methods in a post-COVID world. Instead, it hopes that the impacts of COVID-19 will drive permanent regulatory changes that expand access to DTP capabilities.
One thing remains clear, the pace of adoption of decentralized clinical trials will rely heavily on the ability of clinical trial supply chain partners to connect the physical and digital supply chain.