Notice Number: NOT-EB-18-003
Key Dates
Release Date: January 10, 2018
PAR-18-207
Issued by
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Purpose
The purpose of this Notice is to clarify:
1. the definition and treatment of preliminary data; and
2. the types of clinical trials that NIBIB will support
under the Funding Opportunity Announcement (FOA) PAR-18-207 , NIBIB Trailblazer Award for New and Early Stage Investigators (R21 Clinical Trial Optional).
The following text is added.
In Part 1. Overview Information
Funding Opportunity Purpose
The following text is added.
For this Funding Opportunity Announcement, NIBIB 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. NIBIB 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.
In Part 2. Section I. Funding Opportunity Description
The following text is added.
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 necessary, minimal preliminary data is allowed in support of the feasibility of the research approach. Minimal preliminary data are defined as material which the applicant has independently produced and not yet published in a peer-reviewed journal. For example, unpublished data or data presented in an abstract for a scientific meeting, or used in an oral or poster presentation are acceptable. Such evidence, if provided, should only be used to bolster and help establish the foundational premise for the Trailblazer application. All preliminary data should 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 FOA instructions.
Clinical Trials:
For applications submitted to this FOA that propose clinical trials, NIBIB 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. NIBIB 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 FOA 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 NIBIB supports.
In Part 2. Section IV.2 Content and Form of Application Submission, PHS 398 Research Plan
Currently reads:
Research Strategy:
Trailblazer R21 applications do not require preliminary data or extensive background material. Consequently, determinations of merit and feasibility will rely instead on the conceptual framework, the level of innovation, and the potential to significantly advance our knowledge or understanding. Applicants are encouraged to provide appropriate justification for the proposed work through appropriate literature citations, data from other sources, analytical and computational models, or when available, from investigator-generated data. Since Trailblazer grant applications could involve considerable risk that the proposed work may not be successful, applicants are encouraged to clearly explain the significance of the proposed work, to allow the reviewers to determine whether the potential impact outweighs these risks.
Applications for Trailblazer R21 awards should describe projects distinct from those supported through the traditional R01 mechanism, which are generally longer-term systematic investigations supported by extensive preliminary data. Projects should have well-defined goals with the potential for future development. It is expected that successful projects would go on to further development under other funding mechanisms, such as the R01.
Modified to read:
Trailblazer R21 applications do not require preliminary data or extensive background material. Consequently, determinations of merit and feasibility will rely instead on the conceptual framework, the level of innovation, and the potential to significantly advance our knowledge or understanding. Applicants are encouraged to provide appropriate justification for the proposed work through appropriate literature citations, data from other sources, analytical and computational models, or when available, from investigator-generated data. Since Trailblazer grant applications could involve considerable risk that the proposed work may not be successful, applicants are encouraged to clearly explain the significance of the proposed work, to allow the reviewers to determine whether the potential impact outweighs these risks.
Applications for Trailblazer R21 awards should describe projects distinct from those supported through the traditional R01 mechanism, which are generally longer-term systematic investigations supported by extensive preliminary data. Projects should have well-defined goals with the potential for future development. It is expected that successful projects would go on to further development under other funding mechanisms, such as the R01.
If necessary, minimal preliminary data is allowed in support of the feasibility of the research approach. Minimal preliminary data are defined as material which the applicant has independently produced and not yet published in a peer-reviewed journal. For example, unpublished data or data presented in an abstract for a scientific meeting, or used in an oral or poster presentation are acceptable. Such evidence, if provided, should only be used to bolster and help establish the foundational premise for the Trailblazer application. All preliminary data should 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 FOA instructions.
All other aspects of this FOA remain the same.
Inquiries
Please direct all inquiries to:
Randy King, Ph.D.
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Telephone: 301-451-0707
Email: [email protected]
and Human Services (HHS)
