Clinical Outcome Assessment
What are ePRO and eCOA in Clinical Studies?
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, tablet, or wearable. Another common term related to ePRO is eCOA or electronic clinical outcome assessments. Both involve questions that are presented to a patient using an electronic device. The device, via an app-based platform like Delve Health’s Clinical Study Pal, collects patient-provided information regarding any symptoms, side-effects, drug timing, and other questions presented to a study participant during the course of the trial.
With a hybrid model of BYOD and/or fully configured devices, patients, clinicians, and caregivers can directly report outcomes for more granular endpoint data. (Note: eCOA includes ePRO, ePerfO, eClinRO, and eObsRO).
With a focus on patient centricity in clinical trial design, approximately one-quarter of clinical trials today now include patient-reported outcomes. In 2014, it was estimated that roughly half of clinical trials were still using paper forms. However, advances in technology have been made since then and research suggests that collecting patient data electronically may have benefits for the patient experience as well as data quality—never mind the environmental impact of using less paper.
Using ePRO/eCOA in a clinical trial starts with thoughtful trial design. A clinical research team will decide what datapoints and feedback they want from patients, and the best format to capture that information, whether through an app, e-patient diary, wearable, or other form. Patients may use devices provided by the trial, or install an app such as Clinical Study Pal on their own device. Once the ePRO/eCOA forms are completed, a site can remotely monitor patient responses to the e-diary questions, again increasing patient compliance and improve the patient experience with the trial overall.
Benefits of Using ePRO/eCOA in Clinical Trials
While some measures can be effectively captured during site visits, others, such as pain symptoms, are better tracked in real-time. This is exactly where patient-reported outcomes come in, and research suggests that in most cases, capturing PROs/COAs electronically leads to higher quality data.
For example, 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. The study’s data variability was reduced by 33%, when compared with a previous paper diary trial, increasing the statistical significance of the study from 80% to 98%.
It is important to note that patients tend to prefer using ePRO apps over paper diaries, as well. In a study conducted by the pharmaceutical company Almac (2013), more than 75% of patients preferred answering questions electronically versus on paper forms.