MP33-01 UROLOGIC ONCOLOGY TRIALS ARE NEEDLESSLY EXCLUDING PATIENTS

You have accessJournal of UrologyHealth Services Research: Quality Improvement & Patient Safety II (MP33)1 May 2024MP33-01 UROLOGIC ONCOLOGY TRIALS ARE NEEDLESSLY EXCLUDING PATIENTS Merrick Bank, Madison Krischak, Patrick Lewicki, Rishi Sekar, Lindsey Herrel, Gretchen Piatt, Khurshid Ghani, Randy Vince, and Kristian Stensland Merrick BankMerrick Bank , Madison KrischakMadison Krischak , Patrick LewickiPatrick Lewicki , Rishi SekarRishi Sekar , Lindsey HerrelLindsey Herrel , Gretchen PiattGretchen Piatt , Khurshid GhaniKhurshid Ghani , Randy VinceRandy Vince , and Kristian StenslandKristian Stensland View All Author Informationhttps://doi.org/10.1097/01.JU.0001009520.30626.80.01AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Clinical trials play a pivotal role in advancing treatments for people with cancer, but 1 in 5 urologic oncology trials fails to reach its endpoint, mostly due to low enrollment. One possible contributor is unnecessary exclusion criteria, such as excluding patients due to renal function when the study drug has no renal effects. This needlessly limits the pool of eligible patients, adds complexity to the patient screening process, and raises issues of inequitable access to trials. However, the variability in cancer trial eligibility criteria remains unknown, partially because these criteria are stored as free text, making analysis difficult. 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 2007-2021. 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, 297 (34%) listed renal function eligibility restrictions, and 421 (50%) tested an intervention with possible renal effects (i.e., potential renal toxicity or significant renal clearance). Of trials with renal function exclusions, 55% tested interventions with no renal effect. Conversely, of 421 trials testing interventions with potential renal effects, only 169 (37%) had renal function exclusions in the eligibility criteria. Of the 297 trials with renal function exclusions, only 44 (15%) provided a preferred GFR equation. CONCLUSIONS: There is a major disconnect in urologic oncology clinical trials between renal function exclusions and potential harm to the kidneys from the tested interventions. Of trials with renal function exclusions, over half test interventions with no potential renal impact. Further, few trials provided a preferred GFR equation, raising issues of inequitable application of exclusion criteria. These results suggest patients are potentially being needlessly excluded from urologic oncology clinical trials, which also limits the generalizability of trial results. 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. Source of Funding: Dr. Stensland is supported by NIH K12 DK111011 and NIH P30-CA046592 © 2024 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 211Issue 5SMay 2024Page: e561 Advertisement Copyright & Permissions© 2024 by American Urological Association Education and Research, Inc.Metrics Author Information Merrick Bank More articles by this author Madison Krischak More articles by this author Patrick Lewicki More articles by this author Rishi Sekar More articles by this author Lindsey Herrel More articles by this author Gretchen Piatt More articles by this author Khurshid Ghani More articles by this author Randy Vince More articles by this author Kristian Stensland More articles by this author Expand All Advertisement PDF downloadLoading ...