Translating Clinical Trial Results into Routine Practice: A Systematic Review of Reproducibility, Reporting, and Transparency In High-Impact Radiation Oncology Trials
Abstract
Purpose
Phase II and III clinical trials establish standards of care in radiation oncology; however, achieving equivalent clinical outcomes in routine practice depends on the reproducible implementation of trial protocols. We systematically evaluated whether published trial protocols and manuscripts from high-impact radiation oncology trials report sufficient technical details to enable reproducible implementation in routine clinical practice.
Methods
PRISMA methodology was follow for systematic review. We identified Phase II and III clinical trials involving adult participants, where radiotherapy was the primary intervention, with accrual completion between 2016 and 2019. Trials were retrieved from MEDLINE (PubMed) using Advanced Search Builder queries combining “clinical trial,” “radiotherapy” (or “radiation therapy”) and “randomized.” Three independent medical physicists evaluated each trial using a validated assessment rubric encompassing 40 elements: treatment prescription, fractionation, and timing, target delineation, margins, and dose coverage criteria, normal tissue segmentation and dose constraints, simulation and treatment planning techniques, image guidance, dose reporting, data sharing, and credentialing. Reviewer discrepancies were resolved through group discussion to achieve consensus.
Results
This analysis reports results from the first 20 of 77 pre-specified eligible trials. Complete protocol documentation was publicly available for 18/20 (90%) trials. The median proportion of adequately reported technical elements was 53% (IQR [38–58] %). Adequate reporting was frequently observed for treatment prescription, fractionation, and timing (98%), but substantially less reported for target dose coverage criteria (45%), normal tissue segmentation and dose constraints (45%), image guidance (52%), and treatment planning techniques (57%). Data sharing mechanisms were described in 75% of trials.
Conclusion
High-impact radiation oncology trials frequently lack critical technical details necessary for reproducible clinical implementation, potentially contributing to variability in routine clinical practice and limiting translation of trial evidence. These preliminary findings support adoption of standardized radiotherapy protocol reporting and data-sharing frameworks to strengthen implementation fidelity and improve the reliability of trial-to-practice translation.