Prevalence of unnecessary kidney function exclusion criteria in urologic oncology clinical trials.

Autor: Bank M; Department of Urology, Michigan State University, College of Human Medicine, East Lansing, MI; Department of Urology, University of Michigan, Ann Arbor, MI., Krischak M; Department of Urology, University of Michigan, Ann Arbor, MI., Skolarus T; Department of Surgery, Urology Section, University of Chicago, Chicago, IL; Division of Urology, VA Ann Arbor Healthcare System, Ann Arbor, MI., Lewicki P; Department of Urology, University of Michigan, Ann Arbor, MI., Sekar R; Department of Urology, University of Michigan, Ann Arbor, MI., Herrel L; Department of Urology, University of Michigan, Ann Arbor, MI., Barnes GD; Department of Internal Medicine, University of Michigan, Ann Arbor, MI., Ghani K; Department of Urology, University of Michigan, Ann Arbor, MI; Division of Urology, VA Ann Arbor Healthcare System, Ann Arbor, MI., Piatt G; Department of Learning Health Sciences, University of Michigan, Ann Arbor, MI., Vince R; Department of Urology, University Hospitals Health System, Cleveland, OH., Stensland K; Department of Urology, Michigan State University, College of Human Medicine, East Lansing, MI; Division of Urology, VA Ann Arbor Healthcare System, Ann Arbor, MI; Department of Learning Health Sciences, University of Michigan, Ann Arbor, MI. Electronic address: kstens@med.umich.edu.
Jazyk: angličtina
Zdroj: Urologic oncology [Urol Oncol] 2024 Dec; Vol. 42 (12), pp. 452.e15-452.e19. Date of Electronic Publication: 2024 Oct 11.
DOI: 10.1016/j.urolonc.2024.08.017
Abstrakt: Introduction: Clinical trials play a pivotal role in advancing treatments for people with cancer, but often struggle with low enrollment. Unnecessarily including kidney function eligibility criteria when a trial's interventions do not have any potential kidney effects may contribute to this problem by needlessly limiting the pool of eligible patients, adding complexity to the patient screening process, and raising issues of inequitable access to trials. For these reasons, we applied custom natural language processing to assess renal function eligibility criteria, and the appropriateness of these exclusions, within phase 3 urologic oncology trials.
Methods: We accessed all phase 3 urologic oncology trials registered on ClinicalTrials.gov from 2007 to 2021. We used a custom natural language processing script to extract kidney function requirements (e.g., creatinine, GFR) from trial free-text records. For each trial, we manually coded whether any trial intervention affected renal function or was renally excreted. Additionally, we recorded the formula used to calculate GFR in each trial.
Results: Of 850 trials, 299 (35%) listed kidney function eligibility restrictions, and 432 (51%) tested an intervention with possible renal effects. Of the 299 trials with kidney function exclusions, 124 (41%) tested interventions with no kidney effects.
Conclusion: There is a major disconnect in urologic oncology clinical trials between renal function exclusions and potential harm to the kidneys from the tested interventions. Standardizing eligibility criteria and restricting enrollment based on renal function only when necessary has the potential to increase the success, access, and applicability of clinical trials.
Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
(Published by Elsevier Inc.)
Databáze: MEDLINE
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