What is ePRO in clinical trials?

Electronic patient-reported outcomes (ePRO) in a clinical trial allow patients to answer questions and report on their health through an electronic device, such as a smartphone or tablet. With today's focus on patient-centricity in clinical trial design, around a quarter of clinical trials now include patient-reported outcomes. As of 2014, around half of clinical trials were still using paper forms, but research suggests that collecting patient data electronically may benefit the patient experience as well as data quality.

Using ePRO in a clinical trial starts with trial design. A study team will decide what feedback they want from patients and the best format to capture that information, whether through an app, e-patient diary, or other form. Patients may use devices provided by the trial or install an app on their device.

What are the benefits of using ePRO?

While some measures can be effectively captured during site visits, others, such as pain symptoms, are better tracked in real time. Research suggests that capturing PROs electronically can lead to better data quality, as patients can more conveniently make entries when it's convenient and prefer the system over paper diaries. 

How to set up an ePRO trial

If using ePRO for your clinical trial, it can be helpful to bring potential vendors into the conversation early to help with trial design. Even if the protocol is still a draft, vendors can still help develop a user guide for the trial, both for site staff and for patients.

Many vendors offer their own devices and an app that can be used on patients' devices. Talk through which option makes sense for your patient population and the kinds of graphics or charts your patient diary will include. If you're concerned about legibility on smaller screens, for example, providing a tablet for all participants may be the better option. Still torn about BYOD or not? We shared more BYOD pros and cons in a prior blog post.

When you're ready to start finding patients for your new trial, Antidote can help connect you with engaged patients. Download our case studies to learn more about how we connect patients with research.