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Submitting Patient-Reported Outcome Data in Cancer Clinical Trials November 2023

Final Level 2 Guidance
Docket Number:
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research
Oncology Center of Excellence

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 This technical specifications document supplements FDA’s draft guidance for industry Core Patient-Reported Outcomes in Cancer Clinical Trials (June 2021) and the PFDD Guidance series.

Submit Comments

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2018-D-1216.

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