Submitting clinical trial datasets and documentation for clinical outcome assessments using Item Response Theory: guidance for industry : technical specifications document

Submitting clinical trial datasets and documentation for clinical outcome assessments using Item Response Theory: guidance for industry : technical specifications document

Collection:
Health Policy and Services Research
Contributor(s):
Center for Drug Evaluation and Research (U.S.), issuing body.
Publication:
[Silver Spring, MD] : Center for Drug Evaluation and Research, November 2023
Language(s):
English
Format:
Text
Subject(s):
Clinical Trials as Topic
Drug Development
Drug Industry
Government Regulation
Outcome Assessment, Health Care
United States
Genre(s):
Guideline
Technical Report
Abstract:
This document provides technical specifications for the submission of clinical outcome assessment (COA) data that use Item Response Theory (IRT) and supplements the FDA Center for Drug Evaluation and Research (CDER) Patient-Focused Drug Development (PFDD) Methodological Guidance Series. As described in the Biomarkers, EndpointS, and other Tools (BEST) Resource glossary, 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; thus, there are four types of COAs: clinician-reported outcome (ClinRO), patient reported outcome (PRO), observer-reported outcome (ObsRO), and performance outcome (PerfO) measures. IRT is 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. COAs that use IRT include static, fixed-form COAs that are developed and/or scored using IRT or COAs that are administered using IRT-based Computerized Adaptive Testing (CAT). CAT is a sequential form of individual testing administered by a computer in which successive items in the COA measure are selected for administration based primarily on the item’s psychometric properties and content in relation to the patient’s responses to previous items. COAs that use IRT can leverage an item bank for item selection. An item bank represents the total set of items from which a subset is selected during COA measure development or selected for the patient during adaptive testing.
Copyright:
The National Library of Medicine believes this item to be in the public domain. (More information)
Extent:
1 online resource (1 PDF file (20 pages))
NLM Unique ID:
9918733086906676 (See catalog record)
Permanent Link:
http://resource.nlm.nih.gov/9918733086906676