Seize Competitive Advantages with Digital Approaches to Clinical Trials: New Report from Gartner
While technology advancements have transformed various industries during the past several decades, many clinical trials still operate without the benefits of new technologies. Legacy trial approaches—tied closely to in-person site visits—often fail to address some of the biggest challenges in running a clinical trial, including recruiting enough patients, retaining those patients once recruited and enrolled, and ensuring they remain compliant throughout the completion of the study. Sites often fail to meet enrollment rates, prolonging new treatments for those affected by life-threatening and debilitating diseases.
But through technology, patient participation in clinical trials is not limited to physical site visits. In a new report, “Life Science CIOs: Map Your Pathway to Digital Trials,” Gartner examines approaches for digital clinical trial approaches. According to Gartner, “In general, life science CIOs are interested in digital trials because they provide advantages in terms of improved patient centricity, treatment outcomes, and cost optimization.”
Given the inherent challenges surrounding patient enrollment—now compounded by COVID-19—life science companies have surging interest in how digital approaches can benefit their operations. Gartner estimates that by 2021, 40% of the top 100 life science companies will begin to implement digital trial pilot programs.
Gartner describes digital approaches for clinical trials along a continuum of decentralization. This continuum begins with digitally driven strategies for data capture and moving away from paper-based strategies, while maintaining traditional trial management. The next step along the continuum is the digital visit, which replaces some in-site visits with at-home virtual visits. This approach, also known as a hybrid trial, allows flexibility for studies operating in multiple geographies which may or may not support virtual visits.
Beyond hybrid trials, some trials—especially observational studies or rare disease studies with patients spread across many locations—use a digital site approach. With a digital site approach, patient visits are conducted through remote methods without in-person sites. Finally, there are fully digital studies involving virtual aspects like synthetic control arms or virtual twins (like Dassault Systèmes Living Heart Project).
For trials with any virtual elements, Gartner emphasizes the need for eConsent and video chat capabilities to facilitate interaction between sites, patients, and sponsors. Gartner writes, “We see eConsent as the first step in any digital trials program, as use of eConsent both optimizes and ensures compliance for a historically paper-driven startup process that carries regulatory and legal risks.”
In addition to these benefits, eConsent eliminates the need for patients to sign forms in person at sites. During COVID-19 operating conditions, this helps sites and patients mitigate the risk of bringing many people to one location.
Once patients are enrolled, studies with virtual elements depend on video technology to maintain communication between sites and patients. According to Gartner, “Video chat and conferencing is an essential aspect of remote interactions between the subject and site staff, which Gartner sees as the centerpiece of any digital trial offering.”
By making research more patient-centric and giving patients the ability to virtually access and actively engage in their trials, studies can increase engagement and retention rates. Virtual clinical trial visits allow sponsors and researchers to directly collect symptoms from research participants who may not otherwise be able to continue with traditional site visits. In addition, sponsors can virtually screen patients and review medical records, enlarging the number of potential trial subjects, which ultimately increases recruitment and enrollment rates.
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Looking to the future, Gartner acknowledges several challenges around digital trials, including varying maturation levels of different technologies, the complexity of multimodal approaches for hybrid studies, and the difficulty of changing entrenched legacy approaches at scale. But Gartner takes a long-term perspective. They advise, “Digital trials are clearly still evolving, but that doesn’t mean you should hold back—particularly as the world is still dealing with the COVID-19 pandemic. Market confusion is, in fact, an opportunity for your firm to break out early and seize competitive advantage.”
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