The US Food and Drug Administration (FDA) has finalized two guidance documents in its series of guidances related to Patient-Focused Drug Development (PFDD). The documents outline the agency’s thinking on clinical outcome assessment (COA) data that can be used in premarket applications.
FDA published the COA guidances on 3 November 2023. The first guidance details technical specifications that sponsors should consider including in their premarket applications when submitting COA information that uses Item Response Theory (IRT). The COA data could come from a number of sources, including the clinician in the form of a clinician-reported outcome (ClinRO), the patient in the form of a patient-reported outcome (PRO), a non-clinician observer in the form of an observer-reported outcome (ObsRO), and a performance-based assessment in the form of performance outcome (PerfO) measurement…
