Trailblazer Award for New and Early Stage Investigators (R21 Clinical Trial Optional)
Funding Agency:
- National Institutes of Health
The rapid evolution and vitality of the biomedical sciences benefit from the contributions and creativity of investigators in the early stages of their careers, and a continuous infusion of new ideas, techniques, and perspectives from other fields. This Trailblazer Award is an opportunity for New and Early Stage Investigators to pursue research programs at the interface of engineering and/or the physical sciences with the biomedical sciences. Applicants are encouraged to contact the appropriate NIBIB Program Director assigned to their specific scientific program area (https://www.nibib.nih.gov/research-funding) to discuss the appropriateness of the project before submission. This Notice of Funding Opportunity (NOFO) employs an R21 Exploratory/Developmental Research Grant mechanism enhanced to provide $400,000 in direct costs over three years, allowing expanded time and resources to pursue a new or emerging research program.
To help accomplish the goal of enhancing diversity in the NIH-supported research community, applications from investigators from groups that are underrepresented in the biomedical, behavioral or clinical research workforce (see, Notice of NIH’s Interest in Diversity (NOT-OD-20-031); see also data at http://www.nsf.gov/statistics/showpub.cfm?TopID=2&SubID=27 and the most recent report on Women, Minorities, and Persons with Disabilities in Science and Engineering) are encouraged. Such individuals include women, those from underrepresented racial and ethnic groups, those with disabilities, and those from disadvantaged backgrounds. All applicants to this NOFO must meet the NIH definition of New or Early Stage Investigator (https://grants.nih.gov/policy/new_investigators/index.htm).
The application of principles and techniques from engineering and the quantitative sciences, such as physics, mathematics, chemistry, and computer sciences, is providing innovative technologies and novel methods to accelerate the pace of biomedical research, producing new understanding of disease mechanisms and translating these new discoveries to improve human health. The Trailblazer Award seeks to catalyze the development of transdisciplinary research approaches with the potential to open new areas of biomedical investigation.
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.
Preliminary Data: Trailblazer applications are meant to be exploratory, novel, and non-incremental. We encourage the submission of high-risk, high-reward projects. A distinct feature for this FOA is that no preliminary data are required, expected, or encouraged. However, if available, some minimal preliminary data is allowed. Preliminary data are defined as material which the applicant has independently produced and not yet published in a peer-reviewed journal. Such evidence, if provided, should not represent work involving the aims of the Trailblazer application. All preliminary data must be clearly marked and limited to one-half page, which may include one figure. Applications including data more than one-half page or more than one figure will be considered noncompliant with the NOFO instructions and not go forward to review. Figures containing published data must include citations within the figure legend. Published data that is included in the research plan, biographical sketch or elsewhere in the application must be cited adjacent to each occurrence. Data that is published must be unambiguously identified as such within the application. References and data from widely available preprints that have a Digital Object Identifier (DOI) are considered published.
Clinical Trials: For applications submitted that propose clinical trials, this NOFO will only support applications proposing early-stage clinical trials through Phase I, first-in-human, safety, feasibility, or other small clinical trials that inform the early-stage technology development in the submitted application. This NOFO will not support applications proposing Phase II, III, IV or pivotal clinical trials, or trials in which the primary outcome is efficacy, effectiveness, or a post-market concern.
Applicants are strongly encouraged to contact the Scientific/Research contact for this NOFO for guidance in advance of submitting an application to ensure their proposed project is in compliance with new NIH human subjects research and clinical trials policies (https://grants.nih.gov/policy/clinical-trials.htm) and consistent with the types of clinical trial projects that each IC supports.
Not all research endeavors will be suitable for this NOFO. Projects from New and Early Stage Investigators that are supported by extensive preliminary data should be submitted to the Parent R01 Clinical Trial Not Allowed FOA (https://grants.nih.gov/grants/guide/pa-files/pa-20-185.html) or the Parent R01 Clinical Trial Required FOA (https://grants.nih.gov/grants/guide/pa-files/pa-20-183.html) or Stephen I. Katz Early Stage Investigator Research Project Grant (R01 Clinical Trial Not Allowed) (https://grants.nih.gov/grants/guide/pa-files/PAR-21-038.html). Established investigators proposing exploratory and developmental projects should consider the Parent R21 Clinical Trial Not Allowed FOA (https://grants.nih.gov/grants/guide/pa-files/PA-20-195.html) or the Parent R21 Clinical Trial Required FOA (https://grants.nih.gov/grants/guide/pa-files/PA-20-194.html). Projects of limited cost or scope that use widely accepted approaches and methods within well-established fields should be submitted to the Parent R03 FOA (https://grants.nih.gov/grants/guide/pa-files/PA-20-200.html). Projects that propose incremental improvements in well-established areas of investigation are not appropriate for this NOFO.
Application budgets may not exceed $400,000 direct costs over a maximum three-year funding period. No more than $200,000 direct costs may be requested in any single year.
February 16, 2025, June 16, 2025, October 16, 2025
Randy King, Ph.D.
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Telephone: 301-451-0707
Email: Randy.King@nih.gov
Martha C Flanders
NEI - NATIONAL EYE INSTITUTE
Phone: 301-827-5191
E-mail: martha.flanders@nih.gov
Leonid V. Tsap, Ph.D.
National Institute on Aging (NIA)
Phone: 301-594-0277
Email: leonid.tsap@nih.gov