NIAMS Policy for Acceptance of Clinical Trial Applications and Participation in Parent R01 and R21(Clinical Trial Required) Announcements
Notice Number:
NOT-AR-21-009

Key Dates

Release Date:

October 6, 2020

Related Announcements

NOT-AR-18-008 - Revision: NIAMS Only Accepts Clinical Trial Applications Proposing Mechanistic Studies for Clinical Trial Parent R01 and R21 Announcements (Rescinded)

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

PA-20-194 - NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Required)

Issued by

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

Purpose

The purpose of this Notice is to announce NIAMS continued participation in the NIH Research Project Grant (Parent R01 Clinical Trial Required) and the NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Required) Funding Opportunity Announcements (FOAs), and to clarify the types of applications that may be submitted to NIAMS in response to these FOAs and subsequent reissues.

NIAMS will only accept applications in response to the NIH Parent R01 (Clinical Trial Required) and NIH Parent R21(Clinical Trial Required) FOAs that include:

  • Studies that meet NIH’s definition of a clinical trial AND that are mechanistic in nature, such as those that are designed to understand a behavioral or biological process, the pathophysiology of a disease, or the mechanism of action of an intervention.

Examples of types of applications eligible for acceptance under the NIH Parent R01 (Clinical Trial Required) and NIH R21 (Clinical Trial Required) FOAs may include:

  • Studies focused on the prospective use of efficacious interventions (e.g., biomedical, behavioral, cognitive, or other therapeutic approaches), where the intent is to obtain biospecimens (e.g., blood, patient-derived induced pluripotent stem cells) to identify genetic risk associations, novel biochemical, immunological, or physiological measures to examine the disease process, or characterize mechanisms of therapeutic action/intervention.
  • Studies in which an intervention with demonstrated efficacy is being studied to understand mechanisms of response, non-response, or the risk of adverse effects.

Examples of types of applications that NIAMS will not accept under the NIH Parent R01 (Clinical Trial Required) and NIH Parent R21 (Clinical Trial Required) FOAs include, but are not limited to:

  • Studies that do not meet the NIH definition of a clinical trial.
  • Studies that are designed to evaluate pharmacokinetics or pharmacodynamics of an intervention.
  • Early-stage, proof-of-concept trials of novel treatment approaches in humans that are unproven and/or a prerequisite to clinical efficacy trials for pharmacological, device, or behavioral intervention development.
  • Studies in which the primary objective is to test a clinical outcome such as: those that seek to answer specific questions about safety; tolerability; clinical efficacy/effectiveness; clinical management; and/or implementation of pharmacologic, behavioral, biologic, surgical, or device (invasive or non-invasive) interventions, as well as preventive, therapeutic, and services interventions.

Please note, applications submitted in response to the NIH Parent R01 (Clinical Trial Required) and NIH Parent R21 (Clinical Trial Required) FOAs that do NOT include mechanistic clinical trials as defined by this policy notice will be withdrawn.

Applicants proposing a study that is not eligible for the NIH Parent R01 (Clinical Trial Required) or the NIH Parent R21 (Clinical Trial Required) based on this policy should consider submitting their application to a NIAMS clinical trial-specific funding announcement or to other clinical trial required/optional funding announcement in which NIAMS participates.

Applicants are strongly advised to consult with NIAMS program staff for guidance in determining the appropriate funding opportunity prior to submitting an application proposing any type of clinical trial.

Inquiries

Please direct all inquiries to:

NIAMS Clinical Trials
Email: NIAMSclinicaltrials@mail.nih.gov


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices