Comparative study of federally sponsored and industry-sponsored cancer clinical trials in the US

Industry and federal sponsors support much of the US cancer clinical trial enterprise. Industry-sponsored trials have traditionally focused on therapeutic development and regulatory approval, whereas federally sponsored trial have been viewed as addressing broader clinical and public health research questions. Differences between these trial portfolios have not been systematically quantified. A comparative study of interventional clinical trials characterized differences between federally sponsored and industry-sponsored cancer clinical trials in the US initiated between 2008 and 2024. Overall, 11 861 trials were analyzed (18.1% federally sponsored and 81.9% industry-sponsored). Federally sponsored trial were less likely to focus on single-agent drug therapies (48.6% versus 74%; OR 0.28; p<0.001), while they were more likely to evaluate nontreatment interventional trials, including prevention (4.7% versus 1.1%; OR 4.43; p<0.001) and supportive care (2.5% versus 0.9%; OR 2.92; p<0.001). Among trials conducted for the purpose of cancer treatment, federally sponsored studies were more likely to investigate multimodality regimens combining drug and biological agents (19.1% versus 7.4%l OR 2.98; p<0.001) and to combine drug and/or biological agent regimens with radiotherapy (10.5% versus 1.4%; OR 8.22; p<0.001) or surgery (2.5% versus 0.2%; OR 14.09; p<0.001). Federal sponsorship was also associated with greater use of deescalation trial designs (3.1% versus 0.4%; OR 8.38; p<0.001) and trials conducted in rare cancers (17.5% versus 12.1%; OR 1.54; p<0.001) and in children (16.1% versus 5.3%; OR 3.43; p<0.001). The authors conclude that these findings provide an empirical characterization of the complementary and essential roles of federal and industry sponsors in the cancer clinical enterprise.