The value of ePRO Patient Diary in clinical trials


ePRO Patient Diary reported outcomes are patient-provided information about symptoms, side effects, drug timing and other questions recorded on an electronic device during a clinical trial. Patient-reported outcomes (PRO) are helpful for measuring quality of life outcomes from a clinical trial that can't be measured in other ways, such as pain symptoms.

ePRO can captured using an app that can be downloaded onto any device, such as a patient's iPhone or an Android device. Many ePRO vendors also provide physical devices with the technology pre-loaded onto them. The basic feature of ePRO technology is the ability to record responses to trial questions, but can also include features to help improve patient compliance, such as reminder alarms.

Another common term related to ePRO is eCOA, or electronic clinical outcome assessments. As it can be used to refer to ePRO as well as input provided by clinicians, "eCOA" can be considered an umbrella term for electronically recorded outcomes.

Today, more than a quarter of clinical trials use patient-reported outcomes, digital or otherwise. With the healthcare industry's focus on patient centricity, patient-reported outcomes are an important tool for understanding the real impact of a new potential treatment on patients.

In 2009, the FDA released guidelines around the use of PROs to support labeling claims. The FDA also released a report on patient-reported outcomes in medical device premarket submissions and postmarket studies.

One of the most common types of patient-reported outcomes is referred to as health-related quality of life (HRQL). This data point combines physical, social, and emotional well-being associated with the treatment of a condition. It's also a helpful measure because it's not disease-specific, so it can be asked of trial participants in a control group who do not have the condition. It also allows researchers to estimate population norms.

Health behaviors are another commonly-tracked PRO that can be informative to include in a clinical trial. These can include information on exercise, smoking, drinking, etc. and can be used to assess patients' response to health promotion interventions as well as to monitor health behaviors over time.