The Trailblazer Award for New and Early Stage Investigators (R21 Clinical Trial Optional) is offered by the NIH to support innovative research at the interface of engineering, physical sciences, and biomedical sciences. This program targets NIH-defined New and Early Stage Investigators to advance exploratory and high-risk/high-impact research, focusing on novel approaches and ideas rather than incremental advancements. It is unique in that no preliminary data are required or encouraged, although a minimal amount may be included under strict limitations.

Eligible projects can be exploratory, developmental, or proof of concept in nature, and should propose ideas with the potential to transform understanding or practice in biomedical research. The award provides funding of up to $400,000 in direct costs over three years, with no more than $200,000 allowed in any single year. Applications must adhere strictly to NIH guidelines, and non-compliance will result in exclusion from review.

This award is tailored to those who meet the criteria of NIH-defined New or Early Stage Investigators, with a focus on encouraging diversity in the biomedical research workforce. Institutions eligible to apply include higher education institutions, nonprofits, small businesses, local and state governments, and certain federally recognized organizations. However, foreign organizations are not eligible to apply.

The Trailblazer Award supports a wide range of topics, such as technology integration for biomedical use, innovative imaging or diagnostic tools, computational and statistical approaches in biology, and novel applications of artificial intelligence or machine learning in medicine. Each participating NIH institute, such as the National Institute of Biomedical Imaging and Bioengineering (NIBIB), National Eye Institute (NEI), and National Institute on Aging (NIA), has specified areas of interest, and applicants are encouraged to consult relevant program officers before submission.

The review process emphasizes the significance, innovation, and feasibility of the proposed work, as well as the investigator’s expertise and available resources. Applications proposing clinical trials are limited to early-stage studies, such as Phase I trials focused on feasibility or safety. Projects that align with the NIH mission, but require extensive preliminary data or propose incremental research, should pursue other funding mechanisms like the R01.

Key deadlines for this program are February 16, June 16, and October 16 annually, with the earliest start date approximately 10 months after submission. Applicants must complete all necessary registrations, including SAM.gov, Grants.gov, and eRA Commons, well in advance of the deadline to ensure compliance with NIH policies.

The Trailblazer Award represents an opportunity for emerging investigators to establish a foundation for impactful biomedical research. It seeks projects with high potential for future development and that address critical gaps or unmet needs in biomedical science using innovative and interdisciplinary approaches.