The Current State of Funding and Radiation Oncologist Leadership of Clinical Trials Utilizing Radiation Therapy

Abstract

The funding landscape for oncology clinical trials is changing with increasing industry support and decreasing NIH funding. This study aims to characterize sources of funding for interventional clinical trials utilizing radiation therapy (RT), and the status of radiation oncologist (RO) principal investigator (PI) leadership of such clinical trials. We queried clinicaltrials.gov for all open, interventional, phase I-III trials that included RT. Search terms included “radiation therapy” and specific disease-sites within oncologic subspecialties (breast, CNS, genitourinary, gastrointestinal, gynecologic, head and neck, hematologic, sarcoma, thoracic.) Trials were excluded if they did not include RT or were restricted to pediatric patients. Chi-squared testing and logistic regression were used to identify significant associations between clinical trial characteristics and RO PI leadership, and receipt of specific funding types (NIH, industry, or other.) 1,201 trials met the inclusion criteria, of which 41% are US-based trials, 56% international, and 3% both US and international. Radiation oncologists lead 58% of trials, medical oncologists (MO) 22%, surgeons 12%, and other specialties 8%. Types of trials were categorized as 43% RT + drug, 26% RT + drug + surgery, 18% RT alone, and 13% RT + surgery. Among all trials, 49% use chemotherapy, 11% immunotherapy, 9% small molecule inhibitors, 6% biologic therapy, 4% hormonal therapy, and 11% other drug therapies. RO PIs are significantly less likely than other specialties to be the PI on trials involving drug therapy (odds ratio [OR] = 0.23, 95% confidence interval [CI], 0.17-0.31, p<0.001), or surgery (OR=0.71; 95% CI, 0.51-0.99). Funding patterns also vary significantly based on trial-type and PI specialty as RO are significantly more likely to rely on non-NIH/non-industry funding (OR=2.34; 95% CI, 1.23-4.45). Industry funding is more common for trials led by medical oncologists compared with RO (58% vs. 15%, P<0.001), for Phase I (OR=3.11; 95% CI, 1.49-6.47) and II trials (OR=2.30; 95% CI, 1.18-4.47), and trials incorporating immunotherapy (OR=10.64; 95% CI, 6.30-17.99), small molecule inhibitors (OR=6.13; 95% CI, 3.43-10.93) or biologics (OR=3.83; 95% CI, 1.91-7.66). NIH-funding is more common for phase III trials (OR=2.38; 95% CI, 1.12-5.03), and there was no significant association with PI-type. Radiation oncologists lead 58% of all trials utilizing RT as an intervention, but only 49% of trials combining RT with drug therapy and are less likely than other specialties to be the PI of trials combining systemic therapy and/or surgery with RT. Furthermore, industry-supported trials are less likely to have RO leadership. These data suggest a need for RO to advocate for greater leadership in multi-modality trials, NIH-support, and collaboration with industry.