A retrospective study of the impact of comorbidity, polypharmacy and demographic factors on patient inclusion and healthcare delivery in phase I oncology trials
File(s)
Published version
Author(s)
Type
Journal Article
Abstract
Background
Phase I trials include patients with metastatic cancer and complex health conditions. Understanding baseline comorbidity and demographic features is critical to improving trial design.
Methods
We used electronic patient records to study the association of comorbidity, polypharmacy, and demographic factors on trial recruitment, time on trial, and health service utilisation.
Results
A cohort of 1671 patients was considered for allocation to a phase I study, of whom 518 patients were recruited to a phase I study and 1153 patients were not. A multivariable analysis revealed polypharmacy was associated with lower recruitment to phase I trials with an odds ratio of 0.95 (95% CI: [0.92, 0.99], p = 0.01), and a greater number of emergency admissions with a risk ratio of 1.1 (95% CI: [1.03, 1.17], p = 0.01). Interestingly, comorbidity was not associated with lower recruitment but was associated with a lower time on trial with a hazard ratio of 0.75 (95% CI: [0.62, 0.90], p ≤ 0.001). Demographic factors, including ethnicity, distance of residence from the hospital, and index of multiple deprivation, did not significantly influence these parameters.
Conclusion
Polypharmacy and comorbidity should be considered both in the design of phase I oncology trials and in planning for healthcare utilisation during these trials.
Phase I trials include patients with metastatic cancer and complex health conditions. Understanding baseline comorbidity and demographic features is critical to improving trial design.
Methods
We used electronic patient records to study the association of comorbidity, polypharmacy, and demographic factors on trial recruitment, time on trial, and health service utilisation.
Results
A cohort of 1671 patients was considered for allocation to a phase I study, of whom 518 patients were recruited to a phase I study and 1153 patients were not. A multivariable analysis revealed polypharmacy was associated with lower recruitment to phase I trials with an odds ratio of 0.95 (95% CI: [0.92, 0.99], p = 0.01), and a greater number of emergency admissions with a risk ratio of 1.1 (95% CI: [1.03, 1.17], p = 0.01). Interestingly, comorbidity was not associated with lower recruitment but was associated with a lower time on trial with a hazard ratio of 0.75 (95% CI: [0.62, 0.90], p ≤ 0.001). Demographic factors, including ethnicity, distance of residence from the hospital, and index of multiple deprivation, did not significantly influence these parameters.
Conclusion
Polypharmacy and comorbidity should be considered both in the design of phase I oncology trials and in planning for healthcare utilisation during these trials.
Date Issued
2025-08-25
Date Acceptance
2025-06-24
Citation
BJC Reports, 2025, 3
ISSN
2731-9377
Publisher
Nature Portfolio
Journal / Book Title
BJC Reports
Volume
3
Copyright Statement
© The Author(s) 2025 Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/.
License URL
Identifier
https://www.ncbi.nlm.nih.gov/pubmed/40855012
PII: 10.1038/s44276-025-00165-y
Publication Status
Published
Coverage Spatial
England
Article Number
57
Date Publish Online
2025-08-25