USA – FDA explains how to measure symptoms in COVID-19 trials

Investigators should use a patient-reported outcomes approach, with an emphasis on electronic data collection, in their research on therapies to treat or prevent COVID-19, according to a new guidance from the US Food and Drug Administration (FDA).

The guidance, which is effective immediately during the public health emergency of the coronavirus pandemic, outlines how to capture disease-related symptoms in clinical trials focusing on COVID-19 prevention or treatment for outpatient adults and adolescents.

Using patient-reported outcome (PRO) instruments “is advised when measuring signs and symptoms best known by the patient or best measured from the patient perspective,” the agency says in the guidance. Such signs and symptoms might include shortness of breath, pain and fatigue, for example. Sponsors should consult FDA about which PRO instruments to use. Whatever tool an investigator chooses should be evaluated for basic comprehensibility and usability…