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

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

Research output: Contribution to journalArticlepeer-review

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.

Original languageEnglish (US)
Pages (from-to)444-453
Number of pages10
JournalOncology (Switzerland)
Volume99
Issue number7
DOIs
StatePublished - Jun 1 2021

Keywords

  • Cancer
  • Clinical trials
  • Oncology
  • Patient-reported outcomes
  • Phase I

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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