On Dec. 10, 2020, more than 50 international organizations were brought together to form the Decentralized Trials and Research Alliance (DTRA). Primarily sparked by the COVID-19 pandemic, this alliance was created to promote decentralized clinical trial (DCT) methods across the globe. As we’ve all seen, it was clear that the life sciences industry needed immediate adjustment, and actions to accommodate the rapid and unexpected changes.
Decentralized clinical trials are not new to the life science industry, but over the past few years, they have stepped into the spotlight significantly. At the SCOPE Clinical Operations Conference 2022, I noticed that most exhibiting companies had added some form of DCT service offering. Many speakers addressed the challenges of DCTs and how to promote better patient care, focusing on the ease of patient experience. Among the exhibiting companies, it was inspiring to see that so many businesses recognized the importance of providing DCT services to adapt to the rapidly evolving decentralized healthcare and clinical research needs of patients and providers.
As many Contract Research Organizations (CROs) and pharmaceutical companies know, patient compliance is one of the most vital factors of a clinical trial. If a patient deviates from the set parameters or decides to fully remove themselves from the process, their individual data is unusable. According to MD Group, nearly 30% of patients drop out of clinical trials due to time and scheduling conflicts. In this scenario, the average cost to recruit a new patient due to non-compliance is almost $20,000.
DCTs offer a more inclusive, patient-centric approach by allowing patients to participate in remote clinical trials from their homes. Patients with mobility issues or those who do not reside near a clinical trial site benefit from these remote options and significantly enhance compliance due to convenience alone. Because these trials reduce patients’ time and financial burden, clinical trial managers can expedite patient recruitment and drastically reduce drop-out rates.
In the situation where exclusively remote research is not attainable, hybrid clinical trials can be used to combine virtual and in-clinic workflows. This is important to remember as day-to-day in-person interaction becomes more frequent. Necessary or not, DCTs have been shown to provide better results regarding compliance, data retention and patient recruitment. Looking at the bigger picture, these three things are extremely valuable and benefit both patients and researchers.
In contrast to traditional clinical trials, DCTs use telemedicine and mobile healthcare providers to support visits virtually, obtain consent and support the patient in their home. For example, services such as Verustat DCT offerings can be customized to the patient’s requirements. Many service platforms, including Verustat DCT, provide a wide range of offerings, including remote patient monitoring (RPM), telemedicine visits, medical peripheral hardware sourcing, multiple device communication methods, global customs management, Tier 2 technical supportand equipment leasing. DCT services that handle all the logistics involved in getting equipment to and from patients, from inventory to delivery tracking, return management, and cellular and mobile device management, help keep these trials on the right course without additional burden on the research team.
As DCTs become the new standard practice, it is also important to remember that patient usability should be at the center of every remote patient monitoring tool that you implement. One adoption hurdle we have faced at Verustat revolved around password reset. We were able to quickly recognize and implement a long-term solution, but it served as a great reminder that some of the most basic first steps can be a significant roadblock for an end-user. DCT offerings have also highlighted the centricity of patients to a study’s success and the need to support them with the use of medical peripherals in their homes. Along with technical support, it is still critical to have a care coordination call center to support the patient in set up and ongoing support of monitoring devices in their home. Ideally, this should involve a team that can support the patient from a care coordination perspective and not a standard technical call center. As technological advancements are made, it is imperative that we have the ability to recognize imperfections and adapt to make the technology and equipment perform in a way that works for patients and at a level that adequately provides efficient, accurate data to our research teams.
Ultimately, it is important to apply the pros and cons of DCTs to each individual research project. Beyond patient compliance, convenience and data retention, every trial has a different set of goals and requires a wide range of information. With that in mind, DCTs give researchers the ability to recruit larger, more diverse trial groups and expand the study’s reach to under-represented communities. The bottom line is that DCTs are forcing change, but we as study delivery partners must be able to execute these changes.
The focus of decentralized trials should, first and foremost, be on the patient while also addressing the researcher’s need to manage data and protocol delivery within a compliant, patient-first environment. Providing tools and services to increase patient satisfaction should be the primary goal of every DCT.
About Andy Maloy
Andy Maloy, senior vice president of technology and clinical trials at Verustat, has supported hundreds of clinical trials with technology services throughout his career. He has personally witnessed the evolution of today’s DCTs from where they were pre-pandemic. This has helped him design Verustat’s multiple levels of support for DCTs. To learn more about Verustat’s customizable SELECT DCT offering, visit www.verustat.com/clinical-trials.