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

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

Oncology 2021 Apr 6:1-10. Epub 2021 Apr 6.

VA Nebraska Western Iowa Health Care System and University of Nebraska Medical Center, Omaha, Nebraska, USA.

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.

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http://dx.doi.org/10.1159/000514874DOI Listing
April 2021

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