The PRCRP ACCCT Award supports clinical trials that will progress to the next stage of study or improve the standard of care for individuals living with cancer within at least one of the FY23 PRCRP Topic Areas. The ACCCT Award mechanism requires a clinical trial for transition of and the advancement of previously completed pre-clinical research to the clinic. Clinical trials may be designed to evaluate promising new products, pharmacologic agents (drugs or biologics), devices, clinical guidance, and/or emerging approaches and technologies. Proposed projects may range from small proof-of-concept trials (e.g., pilot, first in human, phase 0) to demonstrate the feasibility or inform the design of more advanced trials through large-scale trials to determine efficacy in relevant patient populations.
Funding from this award mechanism must support a clinical trial. A clinical trial is defined as a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include a placebo or another control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes. For more information, a Human Subject Resource Document is provided at https://cdmrp.health.mil/pubs/pdf/ Human%20Subjects%20Resource%20Document.pdf. Principal Investigators (PIs) seeking funding for a preclinical research project should consider one of the other FY23 PRCRP program announcements being offered. Studies that do not seek to measure safety, effectiveness, and/or efficacy outcome(s) of an intervention are not considered clinical trials.
For the purposes of this funding opportunity, “regulatory agency” refers to the U.S. Food and Drug Administration (FDA) or any relevant international regulatory agency unless otherwise noted.