Guide on ‘Item Response Theory’ Clinical Data

FDA has posted a final guidance entitled “Submitting Clinical Trial Datasets and Documentation for Clinical Outcome Assessments Using Item Response Theory.” The document provides technical specifications for submitting clinical outcome assessment (COA) data that use “Item Response Theory (IRT)” under CDER’s Patient-Focused Drug Development program. It explains that a COA “refers to the assessment of a clinical outcome made through a report by a clinician, a patient, a non-clinician observer, or through a performance-based assessment.”

The guidance describes IRT as a “family of mathematical models that describes the functional relationship between item performance, item characteristics, and the patient’s status on the construct being measured.” It notes that COAs that use IRT include static, fixed-form COAs that are developed using IRT, or COAs that are administered using IRT-based computerized adaptive testing.