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# Patient-Reported Outcome Instrument in Lung Cancer Qualified
- URL: https://www.fdaweb.com/patient-reported-outcome-instrument-in-lung-cancer-qualified/
- Published: 2018-04-16T12:00:00.000Z
- Updated: 2026-09-14T23:59:15.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141221

FDA says it has qualified the use of a patient-reported outcome [instrument ](https://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/DrugDevelopmentToolsQualificationProgram/UCM604610.pdf?ref=fdaweb.com)for exploratory use to measure symptoms of non-small cell lung cancer. Before using the “Qualification of Non-Small Cell Lung Cancer Symptom Assessment Questionnaire,” the agency recommends that sponsors should engage the review division early and throughout drug development to discuss its use to support labeling claims for their drug development programs. FDA notes that further evaluation is needed on the questionnaire’s “longitudinal measurement properties and the interpretation of clinically meaningful within-patient change in score. It is recommended that this information be obtained in early phase studies in drug development programs.”