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

Oncology. 2021;99(7):444-453. doi: 10.1159/000514874. Epub 2021 Apr 6.

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.

Publication types

  • Clinical Trial, Phase I
  • Clinical Trial, Phase II

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Aged, 80 and over
  • Cancer Pain
  • Female
  • Humans
  • Male
  • Medical Oncology / methods
  • Mental Health
  • Middle Aged
  • Neoplasms / psychology*
  • Neoplasms / therapy*
  • Patient Reported Outcome Measures*
  • Registries*
  • Young Adult