Why Use ePRO in Clinical Trials?

Electronic patient-reported outcomes (ePRO) in a clinical trial allow patients to answer questions about side effects, symptoms, and quality of life on their own electronic device, or one provided by the study. When used effectively, ePRO in clinical trials have the potential to improve both data quality and the patient experience.

Regardless of how comments are captured, patient-reported outcomes are an important way to include the patient voice during a study. A potential new treatment may impact symptoms, but does that improve the patient’s overall quality of life? Through ePRO technology, including e-patient diaries, apps, and other tools, a study team can ask questions and collect information that can answer these more qualitative questions.

Today, around 25% of studies include patient-reported outcomes. But not as many trials use ePRO as you may expect: As recently as 2014, around half of clinical trials that incorporated patient-reported outcomes were still using paper to collect this feedback. If your study site hasn’t made the switch to ePRO yet, consider these pros and cons.

Benefits of using ePRO

Patients generally prefer ePRO over paper forms. In a 2013 study conducted by pharmaceutical company Almac, more than 75% of patients preferred ePRO over keeping a paper record. If a patient is able to use their own device, they’re even more likely to be compliant in the trial. When incorporating ePRO into your clinical trial design, it’s important to consider whether patients can use their own devices, and what devices will be acceptable for your study.

Better data quality and integration with your other systems. To start, ePRO reduces the risk for human error when responses are entered into a system by the study team. Even without asking additional questions compared with a paper form, electronic patient-reported outcomes also automatically include useful information like a timestamp. Knowing exactly when a patient recorded a symptom or side effect can help a study team better pinpoint the circumstances around an adverse event, for example.

Data from ePROs are also easier to incorporate into other trial data. Today’s ePRO systems can communicate with your other Electronic Data Capture (EDC) technology to keep all of your trial data together in the same place, reducing the burden on site coordinators to manually input patient information.

With the “bring your own device” movement, ePRO can be even more affordable. In the past, studies would provide participants with an electronic device such as a Blackberry for the trial, raising costs. With the “bring your own device” approach, patients can install an app on their own devices. They can also receive reminder alerts to fill out their profile, as well as reminders about study visits. If a study’s protocol is designed so that multiple kinds of devices can be used for ePRO, you can save on costs while making patient compliance even more natural. You’ll also save on staff time spent entering in data from paper forms and reduce quality assurance review time, too.

Downsides to using ePRO

Up-front costs. If you’re investing in new technology, there are likely to be up-front costs associated with implementing ePRO at the beginning. These costs can include the license for your new ePRO technology, staff training, professional services (such as study configuration), and the cost of new devices, if applicable.

Patients sometimes prefer paper. In addition to that remaining 25% or so of patients who preferred paper in Almac’s study, other studies suggests that patients prefer paper over using Interactive Voice Response Systems (IVRS) to record responses. With IVRS, patients provide responses over the phone and in one study, reported feeling frustrated with the automated voice response and even found the waiting music annoying.

Moving away from PROs on paper is likely the right choice for most sites, but take a look at up-front costs and keep the patient experience in mind while making the transition. Ready to work with an ePRO company? Our list of ePRO vendors and questions to ask can help you make your choice. The ePRO Consortium, part of the Critical Path Institute, also has useful resources for designing a trial that will use ePRO.

And when you’re ready to enroll patients in your latest patient-centric trial, Antidote can help.