By Nach Davé and Shari Medendorp
Traditionally, the use of patient-reported outcome (PRO) data has been an adjunct to primary data when it comes to clinical trials; however, in the current environment, reliance on PRO models has gained steam. As the FDA and research community continue to evolve in terms of how and what data gets captured during the COVID-19 pandemic, one of the areas coming to the forefront is data collection using electronic patient-reported outcomes (ePRO) tools.
The FDA defines a PRO 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.” 1 In general, data from a PRO can be used to predict trends in a population or identify complications or difficulties associated with a particular study protocol or its procedures. Up to the point of the current pandemic, researchers typically utilized PROs to gather secondary endpoints or support a primary endpoint with additional real-world experience. However, we have managed several studies that have used these (including ePROs) as primary outcome measures as well.