The advances that have been made in consumer technologies have changed – and for the most part, improved – how we do almost everything. As those technologies have made their way into the clinical development arena, the benefits they offer to clinical trial sponsors and CROs have been significant.
However, some investigative site personnel and patients feel burdened by the amount of technology that’s involved in clinical trial participation. Here we explore the issue of tech fatigue and how electronic data capture (EDC) solutions can evolve to minimize some of the stressors impacting these critical clinical development stakeholders.
What is tech fatigue?
The Site Perspective
For investigative site personnel, technology fatigue relates to the increasing effort that’s required to keep up with the sheer amount of technology that’s being used within given protocols across their various clients.
Through interviews with site personnel, we’ve learned their biggest pain point is the management of the technical devices they’re required to store, inventory, charge, and distribute to clinical trial patients. These include electronic Patient Reported Outcomes (ePRO) devices, tablets, wearables, Holter monitors – the list goes on and on.
Since any given site could be running between 20 to hundreds of clinical trials at a given time, and any/every one of those trials could include a variety of devices, this can create a burden for site personnel. For every patient they are expected to enroll, across hundreds of studies, they could be managing up to a thousand different devices. In addition to needing space to store and charge the technology so it’s ready for patients at the appropriate time, they also need to log the inventory to ensure it’s returned to the correct sponsor/CRO at the end of the trial.
This extends to the respective owners’ manuals and training guides that accompany each of the devices, which site personnel need to ensure are the most up-to-date versions and available to provide their patients during enrollment.
“The solution to tech fatigue may lie in the advancement of today’s proven electronic data capture systems”
– Mike Mendoza, EDC Expert
Trial patient burdens
Clinical trial patients can feel the stress of tech fatigue, too. In many cases, this stems from their understanding of the equipment’s expense and their fears of losing or damaging it, but equally from their eagerness to submit the best data possible amid uncertainty of whether they’re “doing it right.”
Their stressors are not only focused on the entry of the data but also its transmission – which again speaks to their desire to get this important data to the right place. Many sites often end up playing the role of tech support since some patients feel more comfortable calling their study coordinator than a technology providers’ help desk. Site personnel routinely field phone calls from patients with questions about using the devices, what to do when a Wi-Fi or cellular connection isn’t available, etc.
This then comes full circle in adding to the tech fatigue investigative site personnel are experiencing in today’s clinical trials.
How can EDC help?
Ironically, the solution to some of the tech fatigue issues expressed by sites and patients may lie in more technology. Or, better yet, the advancement of technology that’s already established and used in clinical development – electronic data capture systems.
Today, many EDC system providers, including Calyx, offer integration capabilities that pull data captured from other devices into the EDC system to make it easier for site personnel to review.
But, what if EDC could do more? Perhaps by leveraging this integration capability to allow users to use their own equipment and normalize the information, or provide an inventory module that captures, in one place, information on all the devices site personnel are managing for all the studies they’re conducting?
And/or, envision an EDC application that serves as a portal for enrolled patients’ reference materials? Instead of having to store all owners’ manuals, training guides, etc., site personnel could go to one location to either print what’s needed, on-demand, or provide it via email to the patient.
The way technology is advancing – and based on our learnings of what patients and site personnel need to be successful – it’s possible to imagine that the solution to alleviating some of this tech fatigue may be right at our fingertips. We just need to focus on how to advance these familiar tools and collaborate to help these critical trial stakeholders do their important part in providing the data that’s paramount to clinical development success.
Unfortunately, I think the clinical development industry has been slower to adopt technology than has clinical practice. Many companies have fallen into the trap of doing things a certain way, just because it’s familiar and has become the default methodology. Calyx was formed to disrupt the status quo with new technology, and part of my role will be to help clients overcome their resistance to being early adopters of tools that will improve data collection, management, analysis, and submission.