Clinical trial sponsors often rave about the data they collect from mobile devices, and visionaries wax poetic about the ways these datasets—combined with artificial intelligence and machine learning—will change medicine.
But along the way clinical trial sites are drowning in devices and systems and the charging cords for all of them.
The Clinical Trials Transformation Initiative (CTTI) conducted a survey of potential research participants as part of its Mobile Clinical Trials program. The survey found that most potential clinical trial participants said they would be interested in a “mobile” clinical trial, here defined as one in which most of the study data are collected at home using a wrist-worn health monitor and a smart phone app. These survey respondents reported that they would be happier being part of a clinical trial with only three site visits a year rather than a “traditional” trial with more than 13 site visits a year.
But the looming caveat to these preferences is that a large majority of participants—79%—said they would want to contact the clinical trial staff if a device stopped working, and 57% said they preferred to be trained on a new mobile technology by site staff.
Patients want to talk to a real person, Beth Harper, Workforce Innovation Officer, Association of Clinical Research Professionals (ACRP), said in a panel at the end of the final day of SCOPE* last month. And a site, in turn, wants to talk to a real person for technical help as well. A survey of sites reported four hours of wait time for technical assistance, she said. Some sites simply quit enrolling patients because they are so frustrated with the technology.
David Vulcano, Assistant Vice President & Responsible Executive for Clinical Research, Hospital Corporation of America, minced no words. Patient-facing devices are a pain, he said. Sites are responsible for device set up, serve as the device help desk, and troubleshoot participant problems. All of that is uncompensated time for the site, Vulcano said, and it’s not in their area of expertise.
Sean Walsh, Chief Development Officer at Raleigh Neurology Associates, said the site has about 100 clinical trials going on right now. He estimates there are 2-3 devices needed for each trial. He’s hired an IT person to help with the technical aspects of all of the devices, a cost he said is not paid by the study sponsors.
Walsh has had to devote an entire room to charging space, he said. Volcano agreed, saying he has stacks of iPads sitting in a back room; it has become both a space and a security issue.
The reasonable solution, then would be device-agnostic, or BYOD (bring-your-own-device) trials, in which patients use a device they already own to collect data. But patients do prefer provisioned devices.
Slightly more than half of participants in CTTI’s survey expressed a preference for provisioned devices over their own devices; a third didn’t care. Only 13% preferred a BYOD trial. One major concern for patients using their own device: that their own personal data minutes not be used for the trial. Volcano, in reporting his own experiences, said patients would rather have a device supplied than use their own.
Systems, Software, and Step Counters
But sites’ technical challenges go beyond just finding charging space for hundreds of iPads and guarding against theft of hundreds of Fitbits.
Harper cited an ACRP and CenterWatch survey that showed 11 different systems per study (not all devices, but separate systems a site must use). She advocated for the creation of a technology navigator role to help sites manage the different systems and devices they are required to implement.
The panel, though, pled for interoperability between vendors. Your efficiency is our inefficiency, Vulcano said. He advocated for “putting your foot down on eConsent or eSource; they’re all basically the same.” You can actually service a system if you know it well and have been using it.
That’s an expensive and challenging proposition, he acknowledged. But for a freestanding site doing 100 studies—with a nod to Raleigh Neurology Associates—Vulcano believes system investments are worth it for efficiency.
HCA is a hybrid center, though, and Vulcano said that clinical trials will always compete with regular routine care. The reasoning can easily be: if it’s a hassle, rather than invest in eConsent, just stop doing clinical trials and see more patients.