BYOD Trials Growing in Popularity, But Unique Tech Challenges Remain
There’s considerable buzz around the idea of letting trial participants use their own electronic devices to run trial apps, and the strategy has risen in popularity alongside the decentralized trials (DCT) movement. For sites unfamiliar with BYOD (bring your own device) trials, planning and prepping with the technology in mind is essential to managing this still evolving model successfully.
As the name implies, BYOD trials let patients use devices they already own to complete trial tasks, such as electronic patient-reported outcomes (ePRO) and eDiaries. This often involves the use of apps on iOS and Android smartphones, but there’s tremendous flexibility, with Apple Watches, tablets and other internet-connected devices all possibilities if they meet the operating system specs of a trial’s technologies, according to experts at Brooklyn, N.Y. tech firm Datacubed Health. Patient centricity is at the heart of this concept, they say.
“Providing the patient the flexibility to complete study tasks on a device they’re already frequently using limits the possibility of missed study tasks and provides convenience, as they are already familiar with the device setup,” Datacubed’s Solution Architect Natasha Massias and President Kyle Hogan told CenterWatch Weekly in an email.
“It also reduces patient burden for another study thing to remember, especially for patients that are constantly on the go,” such as participants in late-stage oncology trials who may require frequent site visits, they said.
But the BYOD approach comes with some unique challenges, including accommodating a wide variety of devices. There could be different device models, operating systems and notification formats that may all need troubleshooting throughout the trial, Massias and Hogan pointed out, and many sites complain that some sponsor-selected apps have compatibility issues, clunky designs and poor tech support.
Sites should keep the participant learning curve and need for support in mind and account for that in trial expectations. For example, participants may be familiar with the device they will use but unfamiliar with the concept of the study app; site staff should allow extra time in participants’ visits to ensure they’re ready to use it.
Also remember that because participants are using their own devices, they’ll likely be receiving notifications and reminders for personal things as well, creating a risk of them missing trial-related signals, especially if they get annoyed by the study notifications and choose to disable them. They might even turn them off without even realizing it. It’s essential that the design of the trial enables the delivery of meaningful, concise alerts that both get the participant’s attention and encourage them to complete the activities, Massias and Hogan advised.
Overall, sites should “think big but start small” when it comes to BYOD trials. It can be easy to get overwhelmed by the technologies employed in trials. Don’t bite off more than you can chew, they cautioned.
“Many times, sites have multiple trials going on with various apps or software they need to manage. Sites need to be realistic that they may not be able to successfully integrate and set up all the new systems at the same time,” Massias and Hogan said. Sites should look at all the technologies and plan a staged or roll-out approach. “Incorporate and master one new app at a time before presenting it to participants,” they said.
Catherine Gregor, chief clinical trial officer for Florence Healthcare, echoes this sentiment, and advises sites to carefully consider the technology involved and the site resources that are available before accepting a BYOD trial. Evaluate whether the trial and its various technologies will be manageable, resource-wise, based on the needs of the participants and the complexity of the data the trial apps collect.
But despite the potential issues, BYOD trials can cut down on work for site staff, notes Gregor, reducing the need for sites to manage IT inventory and maintain a log of devices coming and going from the site, for example, and cutting down on the amount of tech support site staff need to provide because participants are already familiar with the devices being used. This can be especially helpful for participants with advanced disease states and/or cognitive delay, where it may be difficult if not impossible to train them on a new device. If this can be avoided, she says, site staff can devote more of their time to actual clinical work.
But at the same time, Gregor cautions that these types of trials can see deviations in data quality. When Apple Watches are used for ECG monitoring, for example, it’s possible to see variation in results depending on how much the participants use the device, how often they charge it and how good they are about updating it.
Not all trials using a BYOD strategy confine themselves solely to participant-owned devices, with some also offering site-provisioned devices as an option. Alain Sayegh, chief operating officer for Renovatio Clinical, said that in the BYOD trials they have taken on, participants were given the option of using their own device or taking a sponsor-provided device. Most, if not all, chose to use their own to avoid dealing with two devices. In a few cases, the trial app conflicted with other software on the participants’ phones, and they were forced to use the sponsor device, Sayegh said.
Massias and Hogan believe that the BYOD model isn’t going away and is in fact just starting to take shape. As it evolves, they feel that more considerations need to be made around access and connectivity to account for participants that don’t have smartphones readily available for completing study tasks, including those in underserved areas and underrepresented groups. The flexibility of doing trial activities by phone is just the beginning, they say.
“It will be interesting to see what additional autonomy patients will have in the future. Perhaps there will be a way — regulatory concerns considered, of course — for patients to interact with one another within the study” or more apps designed with full offline capability to reduce the need for internet connection, they said.
For Gregor, it remains to be seen whether the increased interest in BYOD trials will continue to climb. Long-term, sustained interest will, in her mind, depend on whether BYOD trials are deployed in a successful manner.
“Site adoption and patient adoption of technology are what ultimately drives change, and there’s a lot of interest in leveraging this,” she said. “But if we’re not intentional in how we roll these technologies out, how we incorporate them on the front end, that change management becomes much harder, and people will just look away from something that’s difficult to deal with despite the long-term benefit.”