Over the past decade, the “patient-centered” label has been glibly attached to many organizing processes and principles: health services, care pathways, medical homes, integrated care, drug development, drug commercialization—you name it. Yet the characterization of those activities as patient-centered has typically come from healthcare leaders, marketing executives, sales managers, service leads, politicians and even insurers. Pretty much anyone but the patient.
What can be done to restore authenticity to this concept? How can it realize its potential to improve the patient experience and achieve better health outcomes from a patient perspective? Can the industry get a second chance?
While patient-centricity is not a new idea, decentralized clinical trials (DCTs) are a recent reconceptualization of medical research design that embody a patient-centric mindset. The FDA has defined them as the decentralization of clinical operations where technologies such as digital applications and remote sensors are used to communicate with participants and collect data. The DCT toolbox contains digital measurement devices, remote tracking and monitoring technologies, home health visits, direct-to-consumer drug distribution and the use of local labs as alternative ways to engage participants outside of traditional clinical settings.
In essence, DCTs are a new research paradigm that wraps clinical trial processes and formats around participants’ individual circumstances, preferences and characteristics (the guiding principles of patient centricity) rather than the other way around. At the same time, they represent a gradual shift away from a trial methodology that requires compliance with rigid protocols, such as periodic check-ins at brick-and-mortar central research sites. That’s why, in our view, DCTs hold the key to breathing new life into the concept of patient-centricity.
Because of their technology-facilitated design, which can be optimized to simultaneously match research goals and participant limitations, DCTs present an opportunity for the life sciences industry to integrate true patient-centricity in its R&D processes, while sidestepping the “errors of hype” of the care delivery industry. The comparison is useful because both industries are evolving in the same direction, even as they cater to different points along people’s treatment journeys.
Leveraging patient-centricity in clinical trials may seem limited from the get-go, due to privacy concerns and regulations around collection and processing of patient data. However, the FDA is very much attuned to the issue. Over the past few years it has signaled its increasingly favorable stance toward evaluating trial data that contains participant input (see the FDA guidance on patient-focused drug development). DCTs respond to this expectation because they make the collection of multidimensional patient data, including biometric information and descriptive input, far easier than traditional research studies.
The versatility of DCTs is also important because the success of clinical studies is measured across several key categories that are likely to improve as a result of creating sticky clinical trial experiences. Decentralizing the way patients engage with research sites adds convenience, ease of use and, due to the increased role of digitization, a potential perception of “gamifying” participation. In turn, convenience and improved user experience improve enrollment and reduce dropout rates. By contrast, as of 2015, up to 30% of phase 3 studies were reported to have terminated due to enrollment challenges, while up to 80% of all trials failed to meet enrollment target and timelines. Decentralization of medical research also brings efficiency, which can lead to significantly reduced trial life cycles and potentially smaller sample sizes. Eventually, embedding a patient-centric focus and feedback loop throughout trials leads to better protocol and product design.
Due to their capabilities to collect patient data in more continuous and user-initiated ways than traditional clinical trials, DCTs are capable of positively impacting all of those aspects.
ZS’s Ahmed Albaiti commented in a webinar on the benefits of DCTs: “As a consequence of the COVID-19 pandemic, we see sponsors and the supporting ecosystem really stepping up to execute DCTs at an impressive rate. With patient safety concerns heightened, you need to have a decentralized-first and patient-first mindset.”
Last but not least, people living in rural or far-flung communities, as well as people from ethnic minority groups and other hard-to-reach or overlooked populations, rarely if ever get a chance to participate in clinical trials. DCTs extend this opportunity to them by delinking participation from a central research site and lowering the barrier to entry. Beyond reflecting individual preferences and limitations, patient-centricity in research is also about making sure the population for whom a treatment is being developed is fairly represented. In this aspect too, DCTs are uniquely positioned to democratize and humanize clinical trials.
Patient-centricity has been so evangelized that it can be hard to tell where the hype ends and the authenticity begins. Along with all the havoc it has wreaked, the COVID-19 pandemic has served as a tipping point for reinvention in clinical trials, as in so many other industries. We believe the work-from-home, people-over-processes zeitgeist it has ushered in is the perfect background against which DCTs will help medical research level with patients.