@article{8216b1555d84464a99dcfc08bed6e6c1,
title = "The Use of Patient-Reported Outcome Measures in Phase i Oncology Clinical Trials",
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.",
keywords = "Cancer, Clinical trials, Oncology, Patient-reported outcomes, Phase I",
author = "Coleman, {Robert L.} and Beck, {J. Thaddeus} and Baranda, {Joaquina C.} and Ira Jacobs and Smoyer, {Karen E.} and Lee, {Lauren J.} and Zemfira Askerova and Justin McGinnis and Ganti, {Apar Kishor}",
note = "Funding Information: R.L. Coleman has received grant funding from AbbVie, Astra-Zeneca, Clovis, Roche/Genentech, Genmab, Immunogen, Janssen, Merck, and Novartis, and served on scientific steering committees for AbbVie, Agenus, AstraZeneca, Clovis, Genmab, Immunogen, Janssen, Merck, Roche/Genentech, and GlaxoSmithKline. J.T. Beck has received research grant funding from Pfizer, Merck, Nek-tar, Roche/Genentech, AbbVie, Clovis, Novartis, Immunomedics, Seattle Genetics, AstraZeneca, Eli Lilly, and Daiichi Sankyo, Inc. J.C. Baranda has received research funding from Astellas, Exelixis, Nektar, Pfizer, Sanofi, Tolero, Xencor, SQZ, and owns stock in Forty Seven, Hylapharm, Zymeworks, Moderna, MorphoSys AG, and Aprea Therapeutics. K.E. Smoyer is an employee and shareholder of Envision Pharma Group, which was paid by Pfizer to conduct this study. I. Jacobs, L.J. Lee, and Z. Askerova are employees of and own stock in Pfizer, Inc. J. McGinnis was an employee Publisher Copyright: {\textcopyright} 2021 The Author(s) Published by S. Karger AG, Basel.",
year = "2021",
month = jun,
day = "1",
doi = "10.1159/000514874",
language = "English (US)",
volume = "99",
pages = "444--453",
journal = "Oncology (Switzerland)",
issn = "0030-2414",
publisher = "UBM Medica Healthcare Publications",
number = "7",
}