Revision: NIAMS Only Accepts Clinical Trial Applications Proposing Mechanistic Studies for Clinical Trial Parent R01 and R21 Announcements

Notice Number: NOT-AR-18-008

Key Dates
Release Date:   November 3, 2017

Related Announcements
PA-18-345
PA-18-344
NOT-AR-16-015  Rescinded

Issued by
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Purpose

The purpose of this Notice is to inform potential applicants that, effective immediately, NIAMS will accept only mechanistic studies that meet NIH's definition of a clinical trial in response to PA-18-345 NIH Research Project Grant (Parent R01 Clinical Trial Required) and PA-18-344 NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Required) and its reissues. A mechanistic study is defined as one designed to understand a behavioral or biological process, the pathophysiology of a disease, or the mechanism of action of an intervention.

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)

Note that NIAMS will not accept applications submitted in response to these FOAs that include a clinical trial in which the primary objective is to test a clinical outcome. A clinical trial outcome is a study designed with the objective of evaluating the safety, tolerability, efficacy and/or effectiveness of pharmacological, behavioral, biological, surgical, or devise (invasive or non-invasive) interventions. Such trials will only be accepted through NIAMS-specific FOAs specifically designed for clinical trials.

Additional Considerations
Consultation with NIAMS staff is strongly recommended for investigators planning a clinical trial.  Such consultation is particularly important for those considering an R01 or R21 application that includes a clinical trial with a mechanistic outcome.  If NIAMS determines after submission that a clinical outcome is a primary objective of the study, NIAMS will not accept the application.

Inquiries

Please direct all inquiries to:

Email: NIAMSclinicaltrials@mail.nih.gov