Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events: Methods for item selection in industry-sponsored oncology clinical trials.
Clin Trials
; 15(6): 616-623, 2018 12.
Article
in En
| MEDLINE
| ID: mdl-30230365
ABSTRACT
As new cancer treatment regimens demonstrate increased potential to improve patients' survival, more focus is directed toward the quality of that extension of life and to obtaining additional information from patients regarding their experience with treatment. The utility of capturing patient-reported treatment-related symptoms to complement traditional clinician-rated symptomatic adverse event reporting is well-documented. The National Cancer Institute's Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events is an item library aimed at capturing patient-reported symptoms to inform the patient perspective on a treatment's tolerability. The U.S. Food and Drug Administration has recommended using the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events in clinical trials. A practical guideline is needed to inform a priori selection of specific Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events items for use in any given industry-sponsored oncology clinical trial. Standardizing this selection process will foster systematic and consistent data collection as part of drug development and enhance our knowledge on how to use patient-relevant information as part of a treatment's risk/benefit assessment. This article presents methods and consensus recommendations for selecting specific Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events items to include in early-phase and late-phase oncology clinical trials.
Key words
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Clinical Trials as Topic
/
Patient Reported Outcome Measures
/
Antineoplastic Agents
Type of study:
Guideline
Aspects:
Patient_preference
Limits:
Animals
/
Humans
Language:
En
Journal:
Clin Trials
Journal subject:
MEDICINA
/
TERAPEUTICA
Year:
2018
Document type:
Article
Affiliation country:
United States