NIBIB Guidance for Support of Clinical Trial Applications
Notice Number:
NOT-EB-21-005

Key Dates

Release Date:

February 18, 2021

Related Announcements

PA-20-183 - Research Project Grant (Parent R01 Clinical Trial Required)

PA-20-261 - PHS 2020-2 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Required)

PA-20-262 - PHS 2020-2 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Required)

PA-20-176 - Mentored Research Scientist Development Award (Parent K01 - Independent Clinical Trial Required)

PA-20-197 - Mentored Quantitative Research Development Award (Parent K25 Independent Clinical Trial Required)

PA-20-202 - Mentored Clinical Scientist Research Career Development Award (Parent K08 Independent Clinical Trial Required)

PA-20-206 - Mentored Patient-Oriented Research Career Development Award (Parent K23 Independent Clinical Trial Required)

PA-20-187 - NIH Pathway to Independence Award (Parent K99/R00 Independent Clinical Trial Required)

NOT-EB-21-015 -Notice of NIBIB Participation to PA-20-194

Issued by

National Institute of Biomedical Imaging and Bioengineering (NIBIB)

Purpose

The Notice informs applicants who plan to submit applications involving clinical trials about the NIBIB's consideration process for support of clinical trials. Effective for applications for the April 5, 2021 receipt dates and beyond, NIBIB will only support early stage clinical trial applications, i.e., feasibility, Phase I, first-in-human, safety, or other small clinical trials, that inform early stage technology development. This guidance applies to applications submitted using the NIH Parent funding opportunity announcements (FOAs) listed in the “Related Announcements” section, and their subsequent reissuances. Under these announcements, NIBIB will not support applications proposing pivotal, Phase II, III, IV, or trials in which the primary outcome is efficacy, effectiveness, or a post-market concern.

NIH defines a clinical trial as “A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes” (NOT-OD-15-015). For additional information on whether a grant application includes an NIH-defined clinical trial, applicants are encouraged to review the Clinical Trial decision tool. Further, the NIH defines a mechanistic study, which may be a clinical trial if it also meets the NIH definition of a clinical trial, as a "study designed to understand a biological or behavioral process, the pathophysiology of a disease, or the mechanism of action of an intervention." Given NIBIB’s mission focus on developing biomedical technologies (as identified by NIBIB's program areas), mechanistic trials are not supported unless the primary focus of the project is on technology development.

In advance of submitting a clinical trial application, applicants are strongly encouraged to consult with the Scientific/Research contacts listed below to ensure that the proposed project is consistent with this guidance and programmatically aligned with NIBIB's mission.

Inquiries

Please direct all inquiries to:

Parent R01 CT Required:

Michael B. Wolfson, Ph.D.
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Phone: 301-451-4778
Email:Michael.Wolfson@nih.gov

Omnibus SBIR and STTR CT Required:

Ilana Goldberg, Ph.D.
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Phone: 301-402-3465
Email: NIBIB-SBIR@mail.nih.gov

Parent Mentored (K) CT Required:

Joan Greve, Ph.D.
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Phone: (301) 451-6649
Email: Joan.Greve@nih.gov


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices