ePRO in clinical trials: To BYOD or not to BYOD?

Electronic patient-reported outcomes (ePRO) in clinical trials effectively gather data and include the patient's voice while reducing the burden of entering data from paper forms. In a clinical trial that uses ePRO, a vendor can provide an electronic device for the study, a site can buy devices and download an ePRO app, or patients can use their own.

The best way to understand ePRO capabilities is to talk directly to the vendor. Many vendors offer several different delivery options for their technology, so it's important to consider the pros and cons when deciding on what kind of device system to use.

Bring-your-own-device: Pros

Increased compliance. One potential benefit of BYOD in a clinical trial is increased compliance. If a patient already carries their device around all day, they may be more likely to comply with the trial's protocol. BYOD is too new for much research around compliance, but anecdotal evidence suggests a positive relationship between BYOD and compliance. For example, the ePRO company Bracket reported better compliance for study participants who used their own devices in a Parkinson's disease trial that the company worked on.

A more comfortable user experience. Theoretically, participants will be more comfortable using their own devices than they would using a new device and may have fewer questions for the study team about how to use the ePRO app or website. Users can adjust reminders and notifications to their preferences, which may also help improve compliance.

Cost savings. Compared with continuing to use paper forms, the up-front costs of using ePRO for the first time can feel high. Purchasing devices for the study would add to the cost, so allowing patients to use their own devices can contribute to savings.

Bring-your-own-device: Cons

Concerns around equivalence testing. If many patients use different phone models and operating systems, equivalence among devices can be a concern. This issue may be of particular concern if patient responses depend on viewing charts or other graphics, which could look different on various screen sizes. A uniformly sized tablet or other device with a large screen may be a better choice in that case.

Device ownership in your patient population. As of 2024, 97% of Americans owned smartphones. Ownership rates vary widely across demographics, however. While 99% of college graduates own smartphones, 83% of people who have a high school diploma or yes do. Consider the target patient population to see if requiring smartphone ownership might lead to patient recruitment challenges.

A variety of devices can make troubleshooting difficult. While patients may feel more comfortable using their own devices, if they do have questions, it may be challenging to train a team to answer them on every device.

The bottom line

Whatever method is chosen for delivering ePRO technology, thoroughly test the tool and provide user guides for patients and site administrators. If this is the first clinical trial using ePRO, it can be helpful to share a draft of the study's protocol with potential vendors so they can help you decide on the best path forward in terms of what devices to include.

When you're ready to recruit patients for your trial, Antidote is here to help. We work with a network of 250+ health nonprofits and patient advocates to connect patients with research. Learn more about how we can help accelerate your study.