Submitting patient-reported outcome data in cancer clinical trials: guidance for industry : technical specifications document

Submitting patient-reported outcome data in cancer clinical trials: guidance for industry : technical specifications document

Collection:
Health Policy and Services Research
Contributor(s):
Center for Drug Evaluation and Research (U.S.), issuing body.
Oncology Center of Excellence (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
Neoplasms -- drug therapy
Patient Reported Outcome Measures
United States
Genre(s):
Guideline
Technical Report
Abstract:
This document provides technical specifications for submitting patient-reported outcome (PRO) data collected in cancer clinical trials to support a marketing application for a medical product in oncology, where a PRO is a type of clinical outcome assessment (COA) used to collect patient experience data. The FDA Patient-Focused Drug Development (PFDD) Glossary defines a PRO as a measurement based on a report that comes directly from the patient (i.e., study subject) about the status of a patient's health condition without interpretation of the patient’s response by a clinician or anyone else, where a PRO can be measured by self-report or by interview, provided that the interviewer records only the patient’s response. This technical specifications document supplements FDA’s draft guidance for industry Core Patient-Reported Outcomes in Cancer Clinical Trials (June 2021) and the PFDD Guidance series.
Copyright:
The National Library of Medicine believes this item to be in the public domain. (More information)
Extent:
1 online resource (1 PDF file (iii, 43 pages))
Illustrations:
Illustrations
NLM Unique ID:
9918733087006676 (See catalog record)
Permanent Link:
http://resource.nlm.nih.gov/9918733087006676