COAs (called eCOAs when captured electronically) are essential to understanding whether a drug is reducing symptoms, improving patients’ quality of life, and improving patients’ ability to perform activities they care about. There are several types of COAs, including:
Patient-reported outcomes (PROs or ePROs), which are based on a report directly from the patient about the status of their own health condition, without interpretation from a clinician or anyone else.
Symptoms or other concepts that are unobservable, known only to the patient, and can only be measured with PROs. For example, pain severity or headache intensity.
Clinician-reported outcomes (ClinROs, eClinROs), based on a report from a trained healthcare professional after observation of a patient’s health condition.
Observer-reported outcomes (ObsROs, eObsROs), based on the report of observable signs, events, or behaviors related to a patient’s health condition by someone other than the patient or a healthcare professional. ObsROs are most commonly reported by a parent, caregiver, or other non-healthcare professional who observes the patient in daily life. Importantly, these assessments do not include medical judgment or interpretation.
Performance outcomes (PerfOs, ePerfOs), based on patient performance of standardized tasks, e.g. word recall or timed walking tests. These can be administered and evaluated by an appropriately trained individual or completed independently.