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 This technical specifications document supplements FDA’s draft guidance for industry Core Patient-Reported Outcomes in Cancer Clinical Trials (June 2021) and the PFDD Guidance series.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