1. Evaluation of Control Arm Quality in Recent Radiation Oncology Randomized Clinical Trials.
- Author
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Ekpunobi IO, Flores LE, Jagsi R, and McClelland S 3rd
- Abstract
Background: For randomized controlled trials (RCTs) to provide the highest levels of evidence for clinical practice, it is ethically imperative for patients assigned to the control arm to receive standard-of-care treatment. Oncologic medical trials investigating new systemic agents have demonstrated a high proportion of RCTs with inadequate control arms. It is unknown whether this finding is prevalent in oncologic trials investigating radiation therapy (RT) for cancer., Methods: ClinicalTrials.gov was queried for registered clinical trials investigating RT in patients with cancer from 2013 to 2023. Each control arm was analyzed, with the standard of care determined by National Comprehensive Cancer Center Network (NCCN) guidelines at the time of initial trial posting., Results: Five hundred eight interventional studies with results registered were included, of which 12 met inclusion criteria for final analysis. Two trials each investigated RT usage in central nervous system, prostate, head and neck, and breast disease sites, and 1 each for lung, hepatobiliary, rectal, and bone disease sites. Most trials were industry-funded (83%); 75% of studies took place in the United States. Hundred percent of trials had an adequate control arm per the corresponding NCCN guidelines., Conclusion: All recently completed oncologic RCTs investigating RT for cancer involved an adequate control arm. This finding contrasts with the high proportion of inadequate control arms in medical oncology trials. These findings suggest that adequate control arm treatments are feasible to achieve in trial design, emphasizing both the need for continued focus on improving the quality of ethical oncologic research trials and a possible subspecialty that may serve as an exemplar., Competing Interests: R.J. has stock options as compensation for her advisory board role in Equity Quotient, a company that evaluates culture in health care companies; she has received personal fees from the Greenwall Foundation, Doris Duke Charitable Foundation, the National Institutes of Health, the Blue Cross Blue Shield Association, Physicians Education Resource, and the American Medical Association; and grants or contracts from the National Institutes of Health, the Doris Duke Charitable Foundation, the American Cancer Society, and the Susan G. Komen Foundation. She has served as an expert witness for Kleinbard, LLC, and Hawks Quindel Law. Dr. McClelland receives research funding from the National Institutes of Health (National Cancer for Advancing Translational Sciences), the Gilead Sciences Research Scholars Program in Solid Tumors Award, the Radiation Oncology Institute, and the Susan G. Komen Career Catalyst Research Grant. The remaining authors declare no conflicts of interest., (Copyright © 2025 Wolters Kluwer Health, Inc. All rights reserved.)
- Published
- 2025
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