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 today 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 have benefits for 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 own device.
What are the benefits of using ePRO?
While some measures can be effectively captured during site visits, others are better tracked as close to real-time as possible, such as pain symptoms. That's where patient-reported outcomes come in, and research suggests that in most cases, capturing PROs electronically leads to better data quality.
In one study researching a potential new treatment for a medication for overactive bladder, patients were asked to track how often they felt the urge to urinate. In the e-diary protocol, patients made self-initiated entries for 91% of their micturitions (urges to urinate) over the course of the day. Compared with a previous paper diary trial, the study's data variability was reduced by 33%, increasing the statistical significance of the study from 80% to 98%.
Patients tend to prefer using ePRO apps over paper diaries, as well. More than 75% of patients preferred answering questions electronically over on paper forms in a 2013 study conducted by pharmaceutical company Almac.
How to set up an ePRO trial
If you're planning to use ePRO for your clinical trial, it can be helpful to bring potential vendors into the conversation early to help with trial design. Even if your protocol is still in a draft form, you can still share what you have and receive a mock-up of what your ePRO instrument might look like. You can then share feedback with your potential ePRO vendors as you make a decision. Your vendor can also help you develop a user guide for your trial, both for your trial team and for patients.
Many vendors offer their own devices as well as an app that can be used on patients' own devices. Talk through which option makes sense for your patient population, as well as for 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 on to BYOD or not to BYOD? We shared more BYOD pros and cons in a prior blog post.
And when you're ready to start finding patients for your new trial, Antidote can help connect you with engaged patients. Learn more about how we connect patients with research by downloading our case studies.