This Funding Opportunity Announcement (FOA) supports preclinical and early phase clinical research, as well as correlative studies, directly related to advancements in cancer treatment, diagnosis, prevention, comparative oncology, symptom management, or reduction of cancer disparities. This includes (but is not limited to) development and testing of the following: new molecular agents or biologics for cancer treatment; management strategies for cancer-related symptoms or treatment-related toxicity; cancer screening or diagnostic tools, such as imaging techniques; cancer preventive agents or approaches; predictive and prognostic biomarkers for patient selection or stratification; clinically relevant in vivo or in vitro tumor models (including genetically engineered mouse models, patient-derived xenograft models, organoids, and cell lines); and strategies to address therapeutic outcome disparities among underserved populations. In addition to novel agents, new treatment strategies may involve repurposed agents or novel combinations of interventions (including radiation), based on established mechanisms of action. Comparative correlative studies in cancer patients with age, gender, racial/ethnic, or health disparities are encouraged to explore mechanisms underlying their differential responses (efficacy and toxicity) and resistance to therapeutic interventions. Comparative oncology studies in dogs investigating strategies for treatment and diagnosis of human disease are supported as well.
This FOA does not support research that focuses on basic cancer biology (such as studies of cancer-related pathways, molecular mechanisms, or mechanisms of metastasis), late-stage clinical trials, risk assessment studies, epidemiological studies, or studies of behavioral interventions. These applications will be deemed not responsive to this FOA and will not be reviewed (see below for a more detailed description of studies that are not responsive for this FOA).
The R21 mechanism is intended to encourage exploratory and developmental research projects by providing support for the early and conceptual stages of these projects. These studies may involve considerable risk but may lead to breakthroughs in particular areas, or to the development of novel techniques, agents, methodologies, models, or applications that could have a major impact on cancer research (preclinical or clinical).