The DCT-OS: A Technology-first Operating System - Enabling Clinical Trials
As technology-enabled clinical research becomes the new normal, an integrated decentralized clinical trial operating system can ensure quality, deliver consistency and improve the patient experience.
The increasing availability of COVID-19 vaccines has many of us looking forward to a time when everyday things return to a state of normal. Schools and teachers are returning to classrooms, offices and small businesses are reopening, and there’s a palpable sense of optimism that the often-awkward adjustments we’ve all made personally and professionally in the last year are behind us, never to return. In the world of clinical research, however, some pandemic-necessitated adjustments are proving to be more than emergency stopgap measures to ensure trial continuity — and numerous decentralized clinical trial (DCT) tools and methodologies employed within the last year are likely here to stay as part of biopharma’s new normal.
The old normal in clinical research wasn’t working all that well anyway. We’re all familiar with the age-old issues of trials taking too long and costing too much, and long overdue efforts toward patient centricity have only helped to illuminate the tremendous burden of clinical trial participation on patients and investigators. With only 5% of physicians serving as clinical trial investigators—and only 8% of patients participating in trials — the traditional, site-based model was clearly flailing.
But the pandemic forced change, in a big way. As clinical research sites closed around the world, biopharmaceutical companies and CROs quickly incorporated DCT technologies and methods to existing trials. Study visits that had previously been conducted face-to-face were handled via telemedicine — a patient-preferred method — and several other traditional trial activities were also converted to digital and/or remote platforms.
To get a better sense of the scale of these adjustments, Science 37 commissioned a survey of biopharma executives to gauge their experience and perceptions of decentralized clinical trials. According to our survey — conducted by Industry Standard Research (ISR) —more than 60% of biopharma companies conducted a clinical trial using at least some DCT elements within the last year, including a handful (4%) that were conducted fully virtually. What’s more, our findings also show that more than 80% of biopharma companies expect to conduct a clinical trial using at least some DCT elements this year, with close to one-in-six of these studies expected to be fully virtual [FIGURE 1].
While these findings are certainly encouraging, our study also shows that nearly six-out-of-ten biopharma companies do not have the internal capabilities to operationalize any components of a decentralized clinical trial [FIGURE 2]. In lacking internal DCT capabilities but anticipating their increased adoption, biopharma developers will soon be facing a familiar problem — whether to build internal infrastructure to coordinate and integrate DCT into clinical trial operations, or to outsource these activities to any number of service providers.
In either case, these data help illuminate the contours of a future, network-based clinical research ecosystem in which DCT components are integrated into trial protocols from the onset — easing the burden on investigators and patients while providing biopharma developers the requisite level of quality, efficiency, and expertise. But with a seemingly endless array of new DCT technologies and associated vendors, it’s not hard to envision a frustrating, Wild West-like scenario littered with numerous, disconnected platforms of unproven reliability and interoperability.
Since its inception, Science 37 has quietly led the development of decentralized clinical trial technologies and methods, assembling networks and managing the voluminous flow of virtually collected. This experience has convinced us that activating and operationalizing DCT technologies into everyday clinical studies seamlessly requires a common operating system to orchestrate workflow, collect evidence, and manage streams of data from several disparate DCT sources. By consistently orchestrating each DCT touch-point— i.e., telemedicine investigators, remote coordinators, mobile healthcare providers, patient communities, and connected devices — the DCT OS platform provides a seamless experience for trial coordinators, investigators, and patients, while offering clinical research professionals data of unmatched quality.
As no single development model will be sufficient for the clinical research ecosystem of the future, nearly every study will be highly individualized, with each requiring a unique configuration of technologies and networks. Because of its agility, the DCT OS platform can be configured to enable a full decentralized clinical trial or one with just a few elements. It can be configured to leverage patient recruitment networks or mobile nurse networks (or both). It can be configured for early phase studies, late phase studies, non-interventional studies, and so on. The potential applications and combinations are limitless, and all configurations are guided and managed by Science 37’s coordinated expertise.
With a wide majority of biopharma companies planning to conduct a trial with at least some DCT components in the coming year, our study indicates that the industry is increasingly understanding the potential of DCT to accelerate timelines and make trial participation less burdensome for patients and investigators. But our study also finds that most of these companies lack the internal capability and expertise to operationalize any DCT elements at all. Clearly, they’ll need help. And in requiring quality more than anything, biopharma companies will also need coordinated expertise and a technology-led operating system to implement DTC technologies and methods effectively in the connected, patient-centered clinical research ecosystem of tomorrow.