J. V. De La Iglesia, J. J. Caudell, K. Yamoah, E. G. Moros, and K. Latifi; H. Lee Moffitt Cancer Center and Research Institute, Department of Radiation Oncology, Tampa, FL
Purpose/Objective(s): Radiotherapy (RT) is a pillar of cancer treatment, with approximately 50% of patients receiving RT at some point in their treatment course. NCI-Designated Comprehensive Cancer Centers strive to deliver state-of-the-art cancer treatments, with clinical trials (CT) serving as crucial pathways to achieve this objective. As such, radiation oncologists (RO) and medical physicists (MP) assume key roles in the design and conduct of these CT. It is important to recognize the collaborative effort emphasized by the American Association of Physicists in Medicine (AAPM) Task Group 113, which underscores the explicit contributions of MP and other team members in trial preparation. This study aims to assess the prevalence of RT in CT and the involvement of RO and MP are acknowledged as investigators at an NCI-Designated Comprehensive Cancer Center. Materials/
Methods: From our institutional clinical trials management system (CTMS), we identified 608 interventional CT that were activated, amended, suspended, on hold, or returned to an open status between January 2020 and December 2023. Utilizing the Cochran sample size formula for a finite population, with a confidence level of 95% and a margin of error of 5%, a representative sample size of 236 protocols was calculated. From the initial pool, we coded each trial with random numbers using the spreadsheet software function "RANDARRAY" within the range of 1-608. Subsequently, we sorted them from smallest to largest and selected the first 236 trials. Each CT protocol underwent scrutiny to assess the utilization of RT and the involvement of the radiation oncology team in each trial. Results: Of the 236 CT reviewed, 93 (39.4%) involved RT as part of the patient treatment plan. Among these 93 trials utilizing RT, 33.3% were investigator-initiated trials (IIT), 43% were Academic/Collaborative Groups and 23.6% were industry-sponsored trials. Notably, in CT with RT as part of the patient treatment only in 43% the Principal Investigator (PI) was a RO. Only in 6 of 93 CT (6.5%) were MP listed, 5 as sub-investigator, and 1 as other staff. These included one industry sponsored, one grant funded, 2 IITs, and 2 cooperative group CT. Conclusion: RT plays a significant role in CT, however RO and particularly MP appear to be underrepresented as investigators. Successful CT hinge on fostering collaboration among all stakeholders, and proper recognition and involvement of RO and MP as part of the trial staff is imperative to achieve this goal.
