ePRO in Clinical Trials: To BYOD or Not to BYOD?
Electronic patient-reported outcomes (ePRO) in clinical trials are an effective way to gather data and include the patient voice in your trial while reducing the burden of entering data from paper forms. In a clinical trial that uses ePRO, a vendor can either provide an electronic device for the study, a site can buy devices and download an ePRO app, or patients can use their own devices.
Talk to your ePRO vendor about which option is the best fit for your patient population and study. Many vendors offer a few different options for how their technology will be delivered, so chances are, you'll have a choice to make. When making the decision on what kind of device to use for your ePRO trial, it's important to consider the pros and cons.
Increased compliance. One potential benefit of BYOD in a clinical trial is increased compliance. If a patient is already carrying their device around all day, they may be more likely to comply with your trial's protocol. BYOD is too new for there to be much research around compliance, but anecdotal evidence suggests that 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.
For ePRO in general, a 2013 study conducted by pharmaceutical company Almac found that more than 75% of patients preferred ePRO over keeping a paper record.
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 your team about how to use the ePRO app or website. Users can also 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.
Concerns around equivalence testing. If many patients are using 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. In that case, a uniformly sized tablet or other device with a large screen may be a better choice.
Device ownership in your patient population. As of January 2018, 77% of Americans owned smartphones. Ownership rates vary widely across demographics, however. While 91% of college graduates own smartphones, 69% of high school graduates do. Consider your patient population and if requiring smartphone ownership might lead to patient recruitment challenges.
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 your team on how to answer questions on every possible device.
The bottom line
Whichever method you choose for delivering your ePRO technology, be sure to thoroughly test your tool and provide user guides for both patients and site administrators. If you haven't run a clinical trial using ePRO before, it can be helpful to share a draft of your study's protocol with potential vendors so they can help you make the decision on the best path forward in terms of what kind of devices to include.
And when you're ready to recruit patients into 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.