Open AccessThe Use of Patient-Reported Outcome Measures in Phase I Oncology Clinical Trials
Author(s) -
Robert L. Coleman,
J. Thaddeus Beck,
Joaquina Baranda,
Ira Jacobs,
Karen E. Smoyer,
Lauren J. Lee,
Zemfira Askerova,
Justin M. McGinnis,
Apar Kishor Ganti
Publication year - 2021
Publication title -
oncology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.987
H-Index - 98
eISSN - 1423-0232
pISSN - 0030-2414
DOI - 10.1159/000514874
Subject(s) - clinical trial , medicine , clinical oncology , oncology , cancer
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.