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 has the potential to improve both data quality and the patient experience.

Regardless of how comments are captured, patient-reported outcomes are a valuable way to include the patient's 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 in a clinical trial

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 more likely to offer feedback and be compliant in the trial. When incorporating ePRO into a clinical trial design, it’s important to consider whether patients can use their own devices and how patient-centric the process is.

Better data quality and integration with your other systems. To start, ePRO reduces the risk of 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 other Electronic Data Capture (EDC) technologies to keep trial data organize, 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, it's possible to save on costs while making patient compliance even more natural.

Downsides to using ePRO

Up-front costs. When investing in new ePRO technology, there are likely to be up-front costs associated. These costs can include the license for a 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 the 25% of patients who preferred paper in Almac’s study, other studies suggest 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. When you’re ready to enroll patients in your latest patient-centric trial, Antidote can help.