Summary: The fiscal year 2025 (FY25) Peer Reviewed Cancer Research Program (PRCRP) Clinical Trial Award (CTA) supports the rapid implementation of clinical trials with the potential to have a significant impact on the treatment or management of cancer within at least one of the FY25 PRCRP topic areas. 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) that evaluate the effects of interventions or inform the design of more advanced trials to large-scale trials (up to phase III) to determine efficacy in relevant patient populations.

Distinctive Features:

• Applications to this award mechanism must include a clinical trial.

• Projects can range from phase 0 to phase III.

• If an Investigational New Drug Application (IND) or an Investigational Device Exemption (IDE) is required, the application must be submitted to the FDA prior to the FY25 PRCRP Clinical Trial Award application submission deadline (this includes clinical trials requesting exception from informed consent under Code of Federal Regulations, Title 21, Part 50.24 (21 CFR 50.24).

• Animal studies are NOT allowed under this award mechanism. All preclinical work must be completed prior to the award start date.

Funding Details: (New for FY25) Funding limits are now listed as total cost limits, which is the combination of both direct and indirect costs.

Miscellaneous

• Unrestricted