Notice Number: NOT-OD-18-010

Key Dates
Release Date: October 25, 2017

Issued by
National Institutes of Health (NIH)

Purpose

The purpose of this Notice is to announce NIH’s plan to publish NIH Research Project Grant (Parent R01 Clinical Trial Required) and NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Required) Funding Opportunity Announcements (FOAs) in November 2017 to be used for applications targeting due dates on or after January 25, 2018. Some NIH Institutes and Centers will join these parent FOAs and others will jointly or alone publish IC-specific Clinical Trial FOAs using the same definition of trials described below but will also include additional IC requirements.

Unless otherwise noted, these Parent Clinical Trial Required FOAs will accept trials of safety and efficacy, as well as mechanistic and other types of trials. Some ICs will accept only mechanistic trials to these Parent Clinical Trial FOAs.

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)

NIH not only supports trials of safety and efficacy, it also supports mechanistic exploratory studies that meet the definition of a clinical trial and are designed to explore or understand a biological or behavioral process, the pathophysiology of a disease, or the mechanism of action of an intervention. These studies may focus on basic and/or translational discovery research in healthy human subjects and in human subjects who are affected by the pathophysiology of diseases and disorders. By addressing basic questions and concepts in biology, behavior, and pathophysiology, these studies may provide insight into understanding human diseases and disorders along with potential treatments or preventive strategies. NIH also supports biomarker studies that meet the definition of a clinical trial and that may provide information about physiological function, target engagement of novel therapeutics, and/or the impact of therapeutics on treatment response. NIH thus supports studies that meet the definition of clinical trials (as noted above) but do not seek to establish safety, clinical efficacy, effectiveness, clinical management, and/or implementation of preventive, therapeutic, and services interventions.

Examples of mechanistic clinical trials include but are not limited to:

• Studies that use a manipulation (physiological or behavioral) to answer basic science questions about normal functions.
• Studies that use an experimental manipulation in order to understand normal functioning or the pathophysiology of a disease or disorder, but do not aim to demonstrate clinical improvement.
• Studies that involve the prospective use of efficacious interventions where the intent is to obtain and analyze biospecimens to identify genetic risk associations, novel biomarkers, examine the disease process, or characterize mechanisms of therapeutic response.
• Studies in which an intervention with demonstrated efficacy for a population is being studied to understand mechanisms of response, non-response, or risk of adverse effects of the efficacious intervention.

Inquiries

Please direct all inquiries to:

NIH Grants Information
Email: grantsinfo@od.nih.gov (preferred method of contact)
Telephone: 301-945-7573