A Long-Time Pharmaceutical Executive’s Experience Participating in a Clinical Trial
With 15 years of experience in pharmaceuticals, Science 37’s Leah Zilla thought she knew what to expect when she signed up for a traditional trial for a COVID-19 vaccine. Her experience proves otherwise. For Leah, it quickly became apparent that traditional clinical trials are not optimized toward patient convenience.
Navigating the litany of inefficiencies from a participant's perspective became a frustrating exercise in empathy. Leah explains, “I’ve been on the side where I sit and listen to clinical teams writing protocols and hearing what they are trying to do to minimize the burden, but I don’t really think they truly understand how much of a trial participation is a pain.” Thankfully, Leah walked away with a renewed appreciation for decentralized clinical trials and the COVID-19 vaccine that led her to the study in the first place.
Perhaps the most jarring realization Leah experienced was the tremendous amount of time that was squandered due to inefficiencies. Leah knew that participating in trials was time-consuming, but experiencing the process as a patient was revelatory. “Although I totally appreciate the order of operation for who does what in a trial, as a patient, it’s a huge waste of my time. While the site staff is handling processes, I could be sitting at home working on my computer,” she said. “As a healthy person, I can take on that burden, but I can’t imagine the challenge if I was actually battling an illness.” Ultimately, the experience led Leah to reaffirm her belief in decentralized clinical trials. As she put it, “there are just so many advantages.”
Travel time can increase a patient’s burden of participation exponentially. Not only do patients have to find a means of traveling to the trial site, they often must make arrangements to take time off of work. Issues with transportation can also hinder participation consistency and retention. Additionally, a great majority of clinical trial participants are battling illness, making the prospect of traveling even more daunting.
The advent of decentralized trials is revolutionizing access to trials in a way that extends far beyond convenience. DCTs significantly decrease barriers posed by geographical and scheduling constraints. In a decentralized clinical trial model, telemedicine appointments allow patients to connect with investigators at home - with the option to have mobile healthcare visit patients during the visit to administer medications and collect endpoint data. Instead of driving to a clinic and waiting in a waiting room, participants can re-create the office without leaving their homes. This ultimately decreases patient burden and increases retention.
Leah’s insider knowledge allowed her to identify other inefficiencies in traditional trials. Trial participation requires a great deal of documentation, which can quickly become cumbersome. While decentralized trials embrace technology that streamlines administrative tasks, the traditional study felt antiquated and cumbersome. “Once the original informed consent was complete, future consents for protocol amendments were handled via paper. Upon signature, the paper copy quickly ended up in my recycle bin. The electronic consent form allows for the patient to go back and review key information as needed, in a simple, streamlined process” explained Leah.
While decentralized clinical trial technologies, present numerous benefits, sponsors must incorporate a unified strategy and technology to avoid a new patient burden—the navigation of multiple platforms. A single-sign-on, unified technology platform is quickly becoming a must for clinical trials, as it combines the necessary technology (eConsent, eCOA, Telemedicine, and Connected Devices/Wearables) with the mobile healthcare, telemedicine investigators, and community clinics needed to reach patients remotely. This combination enables patients to be enrolled and seen in the comfort of their own homes rather than co-located to a traditional site.
By using a unified platform, patients can perform most of the functions needed in a clinical trial from a single app that can be downloaded using their personal devices. From that application, they can easily enroll in a study, schedule telemedicine appointments with investigators, and input valuable patient data (eCOA/ePRO). A mobile healthcare team and/or community-based clinics can also be integrated where vitals or other services are involved.
Summing up her experience, Leah admits, “If I didn’t have the carrot at the end of the stick (an early COVID vaccine), I might have dropped out. I value the research and hope to participate in future trials, but part of the ask as a participant will be for a decentralized (at-home) option.”
The advent of decentralized trials and unified technology platforms provides researchers with the tools needed to eliminate inefficiencies and remove barriers of participation— making it possible to bring breakthrough treatments to market faster. For more information on incorporating decentralized elements into your clinical trial, click here.