I Want to Tell You in My Own Words: Patient-Reported Outcomes
Capturing the patient perspective through patient-reported outcomes (PROs) in clinical research provides unique insights into how a therapy affects a patient that standard clinical measurements may not capture. Sponsors can include PROs in clinical trials as primary or secondary endpoints, and regulators, such as the FDA, as well as clinicians, sponsors, and patients increasingly recognize them as a valuable tool to evaluate the safety and efficacy of an investigational product (IP). Read on to learn why PROs are essential, how they can be captured electronically, and how they impact clinical trial participants.
What are patient reported outcomes (PROs)?
PROs are one of the four types of clinical outcome assessments (COAs), which are used to understand the value that a treatment offers by capturing how a patient functions, feels, and survives. PROs are used to measure symptoms that can be known only by the patient, providing real-world evidence such as how a patient is feeling throughout the clinical research.
Examples of PROs include concepts such as pain severity or headache intensity, and are based on a report that comes directly from the patient, without interpretation from a clinician, caretaker, or anyone else.
In addition to PROs, COAs include clinician reported outcomes (ClinRO), observer reported outcomes (ObsRO), and performance outcomes (PerfO).
Why are PROs important?
PROs are uniquely beneficial to all stakeholders in a clinical research trial. Just a few of those benefits are shown below:
- For Patients: Provides an outcome measure from the patient’s perspective, enabling a report on concepts known best or exclusively by the patient, such as pain severity.
- For Clinicians: Offers unique insights into the patient experience that may not be captured through clinical measure.
- For Sponsors: Delivers another type of data point to help determine the safety and efficacy of IP.
Going Digital with ePROs
Historically, participants in a clinical trial have traveled to the research site to complete PROs on paper. However, PROs are now routinely completed electronically due to the benefits offered by this type of data capture. One such benefit is ensuring that PROs are completed at the time specified in the protocol, as the electronic device will time-stamp the data. This also offers this assurance when measuring PROs outside of the clinical setting, such as at home. Furthermore, measuring PROs remotely can reduce the burden on participants, as they may not have to travel to the research site as frequently.
Measuring PROs remotely was also accelerated by the recent COVID-19 pandemic, where many participants already enrolled in clinical trials could no longer attend in-person site visits. In response to this, the FDA issued guidance for conducting trials virtually, accelerating a macro shift toward the electronic capture of COAs. These are known as electronic COAs, or eCOAs, and include ePROs, eClinROs, eObsROs, and ePerfOs.
How ePROs impact participants
This Decentralized Clinical Trial (DCT) framework meets participants where they are, instead of requiring them to travel onsite, lessening the burden on participants and providing access to clinical trials for people who might otherwise have been excluded. Plus, the electronic device that’s used to capture the data could be a participants’ own phone, tablet, or computer. This is known as Bring Your Own Device (BYOD) and allows participants the comfort of using an electronic device they’re already familiar with.
Both the FDA and EMA have recognized that the use of eCOAs, such as ePROs, bring many potential benefits, like improved data integrity, and have expressed support for their use. In addition, eCOAs can help ensure ALCOA compliance on account of that improved data integrity.
Ready to get started with ePROs? Contact Medable, your ePRO and clinical trial partner.