How to Remove Obstacles to Patient Enrollment
Common Enrollment Obstacles
There are many obstacles that prevent people from enrolling in clinical trials. Travel time, distance to trial sites and lack of trial awareness are a few of the primary examples.
Travel for clinical site visits becomes more challenging with every added mile of distance. Over the years, in order to help improve the odds of getting enough clinical trial patients, sponsors relied heavily on study sites with access to large groups of patients, often in or near large cities. However, this approach has led to homogenous participant populations across all therapy research. Why? Because the majority of these participants live closer to major study centers, which are typically large healthcare systems tied to academic institutions.
Another issue that keeps candidates out of clinical trials is the lack of study awareness among clinicians and healthcare sites with little to no research experience. For clinicians who are not linked to traditional academic centers, historically, there hasn’t been a process for them to be notified proactively about studies that might be good for their patients. Clinicians are important gatekeepers for many patients that enter clinical trials, and when they don’t have easy access to data regarding open studies, their patients may miss out on life-changing opportunities.
How Decentralized Clinical Trials (DCTs) Can Help
Unlike traditional clinical trials, decentralized clinical trials (DCTs) take place remotely. DCTs allow sponsors to no longer rely solely on participants who live within reasonable proximity to traditional study sites. DCTs use a range of decentralized methodologies that employ both technology and dispersed in-person care to provide more localized services.
DCTs provide geographic flexibility which allows sponsors to expand their pool of potential trial participants, also increasing diversity within these trials. DCT elements such as sensors, virtual visits and eCOA ( Electronic Clinical Outcome Assessment) sponsors to deliver a trial experience that is less disruptive for patients and their families. Participants are able to receive better access to therapies, clinicians receive more opportunities to participate in trials and sponsors receive better, more comprehensive data based on more representative patient cohorts. 70% of potential clinical trial patients live more than two hours away from a clinical site, but decentralized and hybrid trial models provide patient-centric delivery while decreasing the barriers to participation (1).
DCT approaches can be used to expand recruitment reach in order to find more potential candidates more quickly and meet enrollment requirements. Digital technologies can be used to securely comb through patient data and notify clinicians when their patients might be a good fit for a clinical trial. People trust their physicians, and many might never look into the possibility of clinical trial participation without their doctor’s recommendation, which makes this capability at the point of care extremely powerful. Digital technologies help increase awareness and provide opportunities for even more people to participate in clinical trials.
DCTs and digital approaches can help bring research opportunities to more candidates. The remote aspect of DCTs allows people with different lifestyles, geographic locations, functional capabilities and availability to participate.
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Sources
(1) https://www.ncbi.nlm.nih.gov/books/NBK548971/