339 - From Clinical Trials to Clinical Practice: An Analysis of Reproducibility and Transparency in High-Impact Radiation Oncology Trials
Presenter(s)
S. Quirk1, S. Chitsazzadeh2, K. S. Smith3, T. A. Ritter4, T. M. Roth5, K. Hopfensperger6, C. K. Park7, S. Madhavan8, W. P. Smith9, C. Skourou10, M. Glenn11, A. T. Price12, H. Li13, P. Rassiah14, C. D. Fuller15, J. Lehmann16, M. Sharma17, and M. B. Roumeliotis18; 1Department of Radiation Oncology, Brigham and Women’s Hospital/Dana-Farber Cancer Institute, Boston, MA, 2Mayo Clinic, Phoenix, AZ, 3U Mass Chan Medical School, Worcester, MA, 4Department of Radiation Oncology, Virginia Commonwealth University, Richmond, VA, 5Rhode Island Hospital, Providence, RI, 6Department of Radiation Oncology, University of Michigan, Ann Arbor, MI, 7Department of Radiation Oncology, Mass General Brigham, Harvard Medical School, Boston, MA, 8Memorial Sloan Kettering Cancer Center, New York, NY, 9University of Washington, Department of Radiation Oncology, Seattle, WA, 10St. Luke's Radiation Oncology Network, Dublin, Ireland, 11University of Washington, Seattle, WA, 12Department of Radiation Oncology, University Hospitals Cleveland Medical Center/ Seidman Cancer Center, Cleveland, OH, 13Johns Hopkins University Department of Radiation Oncology, Washington, DC, 14University of Utah Huntsman Cancer Institute, Salt Lake City, UT, 15Division of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, 16The University of Sydney, Newcastle, Australia, 17University of California San Francisco, San Francisco, CA, 18Department of Radiation Oncology and Molecular Radiation Sciences, Johns Hopkins Medicine, Baltimore, MD
Purpose/Objective(s): Phase II and III clinical trials establish standards of care in radiation oncology; however, reliable translation of trial results into routine practice depends on reproducible protocol implementation. We performed a quality improvement focused systematic review to identify system-level gaps in reporting that may limit implementation fidelity and contribute to variability in clinical practice.
Materials/Methods: We identified Phase II and III randomized clinical trials involving adult patients in which radiotherapy was the primary intervention and accrual was completed between 2016 and 2019. Trials were retrieved from MEDLINE (PubMed) using predefined search queries combining “clinical trial,” “radiotherapy” (or “radiation therapy”), and “randomized.” Each trial was independently reviewed by three medical physicists using a structured assessment framework evaluating implementation-relevant protocol elements across key domains, including prescription and fractionation, target and normal tissue definitions, simulation and treatment planning, image guidance, credentialing and quality assurance, dose reporting, and data sharing. Discrepancies were resolved by discussion-based consensus.
Results: This analysis reports initial results from the first 20 of 77 prespecified eligible trials. Complete protocol documentation was publicly available for 18/20 (90%) trials. The median proportion of adequately reported implementation-relevant elements was 53% (IQR 38–58%). Reporting completeness was high for treatment prescription and fractionation (98%) and explicit data sharing statements (75%), but substantially lower for domains critical to reproducible implementation, including target coverage criteria (45%), normal tissue segmentation and dose constraints (45%), image guidance (52%), treatment planning techniques (57%), credentialing requirements (38%), and post-trial dosimetric reporting (26%).
Conclusion: High-impact radiation oncology trials demonstrate substantial deficiencies in reporting elements essential for reproducible clinical implementation. Incomplete documentation of contouring standards, quality assurance requirements, and post-trial dosimetry represents a system-level quality gap that may undermine implementation fidelity and contribute to variability in patient care. These findings support the development of minimum reporting and publishing standards, with early and sustained medical physicist involvement, as a scalable quality improvement strategy to strengthen trial-to-practice translation.
Abstract 339 – Table 1
| Evaluation Category | Elements reported (%) |
|---|---|
| Treatment prescription, fractionation, and treatment timing | 97.5% |
| Data sharing | 75.0% |
| Simulation and treatment planning technique | 56.5% |
| Image guidance | 52.3% |
| Target definition, margins, and dose coverage criteria | 45.1% |
| Normal tissue segmentation and dose constraints | 45.0% |
| Credentialing | 37.8% |
| Dose reporting; post-trial | 26.0% |