This Trailblazer Award is an opportunity for NIH-defined New and Early Stage Investigators to pursue research programs that integrate engineering and the physical sciences with the life and/or biomedical sciences. A Trailblazer project may be exploratory, developmental, proof of concept, or high risk-high impact, and may be technology design-directed, discovery-driven, or hypothesis-driven. Importantly, applicants must propose research approaches for which there are minimal or no preliminary data. A distinct feature for this NOFO is that no preliminary data are required, expected, or encouraged. However, if available, minimal preliminary data are allowed. 

A Trailblazer project may be exploratory, developmental, proof of concept or have high risk-high impact goals. Importantly, the proposed research for this NOFO may be technology design-directed and may or may not be hypothesis-driven. In the context of this NOFO, innovation encompasses approaches to address well-defined, unmet biomedical research needs through the development of new methods, ideas, or technologies; early steps along the path toward delivery of a new capability or method; and the integration of existing components in a previously unproven format. High-impact projects should transform our understanding or practice by applying an innovative approach to an important biomedical challenge. For projects supported by a Trailblazer Award, successful results should provide a solid foundation for further research under other funding mechanisms, such as the R01. Applicants will be considered ineligible for this funding opportunity if they have submitted an R01, R15 or any other R21 application, with a participating IC as the primary IC within the same review cycle. An awardee may not hold concurrent Trailblazer awards.

Trailblazer approaches are expected to differ substantially from current thinking or practice, therefore, extensive preliminary data demonstrating feasibility is an indication that the project is beyond the scope of this NOFO. Reviewers’ determinations of merit will rely instead on the conceptual framework, the level of innovation, and the potential to significantly advance our knowledge, understanding or practice. Applicants can provide appropriate justification for the proposed work through literature citations, data from other publicly available sources, or analytical and computational models. The proposed research will likely involve considerable risk that the work may not be successful, so applicants should clearly explain the significance of the work to allow the reviewers to determine whether the potential impact justifies these risks.