The Use of Patient-Reported Outcome Measures in Phase I Oncology Clinical Trials-Reference-Cited by-同舟云学术

The Use of Patient-Reported Outcome Measures in Phase I Oncology Clinical Trials

Published:2021 Issue:7 Volume:99 Page:444-453
ISSN:0030-2414
Container-title:Oncology
language:en
Short-container-title:Oncology

Author:

Coleman Robert L.,Beck J. Thaddeus,Baranda Joaquina C.,Jacobs Ira,Smoyer Karen E.,Lee Lauren J.,Askerova Zemfira,McGinnis Justin,Ganti Apar Kishor

Abstract

Objective: To investigate patient-reported outcome (PRO) usage in phase I oncology clinical trials, including types of PRO measures and changes over time. Methods: We analyzed ClinicalTrials.gov records of phase I oncology clinical trials completed by December 2019. Results: Of all eligible trials, 2.3% (129/5,515) reported ≥1 PRO, totaling 181 instances of PRO usage. PRO usage increased over time, from 0.6% (trials initiated before 2000) to 3.4% (trials starting between 2015 and 2019). The most common PRO measures were unspecified (29%), tumor-specific (24%), and generic cancer (19%). Conclusion: Although uncommon in phase I oncology clinical trials, PRO usage is increasing over time. PRO measures were often unspecified on ClinicalTrials.gov, suggesting that more precise reporting and standardization are needed.

Publisher

S. Karger AG

Subject

Cancer Research,Oncology,General Medicine

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