The U.S. Food and Drug Administration (FDA) stated that at the Center for Devices and Radiological Health (CDRH), it encourages the inclusion of clinical outcome assessments (COAs) in the evaluation of medical devices.
A COA describes or reflects how a person feels, functions, or survives and can be reported by a healthcare provider or a non-clinical observer (such as a parent), through performance of an activity or task, or by the patient. There are four types of COAs:
· Patient-reported outcomes (PROs),
· Clinician-reported outcomes (ClinROs),
· Observer-reported outcomes (ObsROs), and
· Performance outcomes (PerfOs).
While each COA focuses on the patient, they provide a different perspective on a patient's health status.
PROs provide information on the patient's health condition as directly reported by the patient, without outside interpretation from anyone. These outcomes are assessed using PRO instruments, such as questionnaires, numeric rating scales or diaries.
ClinROs are reports coming from a trained healthcare professional regarding their interpretation of signs or behaviors that can be observed related to a patient's disease or condition.
ObsROs are assessments of observable signs, events or behaviors related to a patient's health condition as reported by individuals who observe the patient in daily life, like parents or caregivers.
PerfOs are measurements collected when a patient is asked to complete a well-defined, repeatable and standardized task such as reading an eye chart.
For regulatory purposes, high-quality information from COAs can provide valuable evidence for benefit-risk assessments. They can also be used in medical device labeling to communicate the effect of a treatment on patient symptoms and functioning. COAs may be used to determine who is eligible for a clinical study and measure how well the device performs in treating or diagnosing the condition. COAs may also be used to help measure the safety of the device. Evidence from COAs may also be useful to payors and healthcare providers.
These case studies highlight the roles COAs can play in clinical investigations supporting medical device submissions. They are not intended to be a comprehensive review of the pivotal clinical studies associated with each submission.
CDRH regularly collaborates with professional societies, academic researchers, patient groups, public-private partnerships, and other stakeholders to advance the development and validation of COAs for regulatory use. For additional information about our workshops on COAs, see Medical Devices Virtual Public Meeting – Patient-Reported Outcomes (PROs) and Medical Device Evaluation: From Conception to Implementation.