The invaluable role of patient-reported outcomes in clinical trials

One of the most valuable outcomes of medical research is the data collected as studies are conducted. Every new study provides researchers with vital information about the impact of potential new treatments on patients and offers useful insights into the practical applications of trial results in the real world.

While the data collected from lab values and regular monitoring are useful, another important — and often underutilized — data source is the information obtained directly from patients. This is referred to as patient-reported outcomes and can give researchers deeper insights into the true impact of a potential treatment on the patient population.

What are patient-reported outcomes in clinical trials?

The FDA defines patient-reported outcomes (PROs) as “any report of the status of a patient’s health condition that comes directly from the patient, without interpretation of the patient’s response by a clinician or anyone else.” Another commonly used acronym is ePRO, which refers to electronic patient-reported outcomes, which simply means that patients complete this process electronically.

Regardless of whether the outcomes are reported digitally or electronically, they can provide valuable insights into patients’ perspectives, including the study’s impact on symptoms, quality of life, satisfaction with treatment, and overall experience of participating in a clinical trial. 

The importance of patient-reported outcomes in clinical trials

Collecting this type of data from patients allows researchers to compile a more holistic view of the intervention being studied and use these insights to further improve the research process. Studies have shown that the use of PROs in clinical trials is linked to a clearer understanding of the cost and benefits of treatment, better insights into the patient experience, and a stronger grasp of where improvements could be made.

In addition to the data-driven focus of PROs, their use is also beneficial for empowering patients and ensuring they feel like true partners in research. Gathering feedback from participants is a strong step towards patient-centricity in clinical trials, as they place a distinct value on patients’ perspectives and their experience with participating in medical research.

How to incorporate patient-reported outcomes into clinical trials

Regardless of what the medical study in question aims to assess, there will likely be a PRO method that works for both participants and researchers. In order to process data effectively and simplify responses, it is best to use a patient-reported outcome response scale.

This is often done through questions with answers that range from “strongly agree” to “strongly disagree,” giving patients the option to mark an area on a continuum, using a pictorial depiction, offering a rating scale, or a simple yes/no checklist. With these methods, patients are given the opportunity to take an active role in research, and the data collected has parameters that researchers can use to glean valuable insights once all the responses are compiled.

At Antidote, conducting patient-centric clinical trials is at the forefront of our mission. To learn more about how we can help you with patient recruitment, get in touch today.