J. V. De La Iglesia, K. Latifi, J. J. Caudell, K. Yamoah, and E. G. Moros; H. Lee Moffitt Cancer Center and Research Institute, Department of Radiation Oncology, Tampa, FL
Purpose/Objective(s): Clinical trials incorporating radiation therapy (RT) are critical in medical research and patient care. In many trials the delivered RT is a standard of care, but each trial presents unique challenges necessitating additional time and support from radiation oncologists, physicists, and dosimetrists. Materials/
Methods: After a thorough analysis of clinical trial workflows, we identified key checkpoints demanding additional effort from the radiation oncology team. Tasks and responsible team members were delineated, and average time in hours for each task was estimated. NIH-approved methodology was used to calculate fees for the different checkpoints, based on staff salary and time invested in each task. Results: Three checkpoints were determined: initial review phase, activation phase, and RT treatment phase. The initial review phase entails operational work to meet protocol requirements, such as credentialing, Imaging and Radiation Oncology Core (IROC) verification, benchmarking, and radiotherapy QA, requiring 20 hours of effort. The activation phase involves operational and support work to meet protocol needs, such as communication with coordinators and sponsors, sponsor training and study-specific boarding pass creation, with 8.5 hours allotted. The RT treatment phase, encompassing per-patient fees, ensured additional support aligned with protocol requirements, such as communication with the research team, de-identification and uploading treatment plan and images to sponsor, de-identifying and uploading clinical data post-treatment, with an allocation of 8 hours per patient. Based on these additional efforts required, a budgetary model was created for industry sponsored clinical trials which has been successfully implemented. Conclusion: This work identified additional effort required on part of a radiation oncology team to manage RT on industry supported clinical trials, with the development of a comprehensive general support budget. These revenues will help support participation and development of clinical trials in radiation oncology.
