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Accepted for/Published in: JMIR Cancer

Date Submitted: Jul 24, 2024
Date Accepted: Jan 27, 2025

The final, peer-reviewed published version of this preprint can be found here:

Leveraging Patient-Reported Outcome Measures for Optimal Dose Selection in Early Phase Cancer Trials

Byrom B, Everhart A, Cordero P, Garratt C, Meyer T

Leveraging Patient-Reported Outcome Measures for Optimal Dose Selection in Early Phase Cancer Trials

JMIR Cancer 2025;11:e64611

DOI: 10.2196/64611

PMID: 40020239

PMCID: 11888580

Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.

Leveraging patient-reported outcome measures for optimal dose selection in early phase cancer trials

  • Bill Byrom; 
  • Anthony Everhart; 
  • Paul Cordero; 
  • Chris Garratt; 
  • Tim Meyer

ABSTRACT

While patient-reported outcome measures (PROMs) are regularly incorporated into phase III clinical trials, there has been little use of PROMs in early phase trials [1]. However, the patient perspective is a vital element of fully understanding dose-toxicity and selecting an optimal dose. This viewpoint paper reviews the rationale for, and practical approach to, collection of patient-reported outcomes (PRO) data in early-phase oncology drug development, and the rationale for electronic collection.


 Citation

Please cite as:

Byrom B, Everhart A, Cordero P, Garratt C, Meyer T

Leveraging Patient-Reported Outcome Measures for Optimal Dose Selection in Early Phase Cancer Trials

JMIR Cancer 2025;11:e64611

DOI: 10.2196/64611

PMID: 40020239

PMCID: 11888580

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