Notice Number: NOT-AI-17-033
Release Date: August 3, 2017
Estimated Publication Date of Announcement: October/November 2017
First Estimated Application Due Date: June 2018
Earliest Estimated Award Date: April 1, 2019
Earliest Estimated Start Date: May 1, 2019
National Institute of Allergy and Infectious Diseases (NIAID)
The National Institutes of Health (NIH) and the National Institute of Allergy and Infectious Diseases (NIAID) intend to publish Funding Opportunity Announcements (FOAs) for competitive new and renewal applications to the Autoimmunity Centers of Excellence (ACE) program, a cooperative network aimed at improving the understanding and treatment of autoimmune diseases (http://www.autoimmunitycenters.org). NIAID intends to renew both the Clinical and Basic halves of the ACE program. This Notice is being issued to allow potential applicants more time to consider the requirements of this program and to develop responsive clinical projects.
This planned FOA will solicit applications for the Clinical research program. Members of the Clinical ACE will collaborate to design and implement clinical trials of interventions to prevent or treat autoimmune diseases. Members of the Basic and Clinical ACE will work together to design and conduct studies of mechanisms of action of potentially disease modifying agents being tested in the clinical trials.
This The Clinical research program will develop and conduct Clinical Projects: clinical trials with integrated mechanistic studies. Well-designed clinical studies can be fundamentally informative whether or not an investigational agent ultimately advances to licensure and clinical practice.
The ACE is designed to accelerate the discovery and translation from lab to clinic of therapies for autoimmune diseases by conducting cooperative basic, clinical, and mechanistic studies, fostering intellectual and material collaborations among basic and clinical scientists, and facilitating the study of clinical samples by basic research scientists. These approaches are expected to identify common and distinct mechanisms in the pathogenesis of autoimmune diseases.
The Clinical ACE will possess the following components:
The Clinical Projects will be phased for development.
A Clinical Project is a clinical trial with integrated mechanistic studies. A clinical trial is a medical research study in humans to evaluate the effects of one or more interventions for treatment of an autoimmune disease. Mechanistic studies are designed to improve the understanding of the mechanism of action of the intervention. In addition to assessing practical questions about the intervention, such as whether the targeted cell or molecule has been affected, these studies should be designed to address fundamental questions about human immunology.
Statistical, Data Management, and Operations Support: NIAID will provide statistical, data collection and management, and clinical trial operations support through a separately-funded DAIT Statistical and Clinical Coordinating Center (SACCC) resource. Each participating institution will be responsible for providing primary study data to the SACCC.
Research Scope: Types of Clinical Projects that may be proposed include but are not limited to the following:
Clinical Projects of particular interest to the ACE include but are not limited to the following areas:
The ACE will NOT support:
A Program Director/Principal Investigator (PD/PI) may NOT apply to both the Clinical and Basic ACE program FOAs.
The Primary and Alternate Clinical Projects must have different leaders and they must address different diseases, though they may be within one clinical specialty.
Foreign (non-US) applications and foreign components will NOT be permitted.
APPLICATIONS ARE NOT BEING SOLICITED AT THIS TIME.
Please direct all inquiries to:
David R. Johnson, PhD
National Institute of Allergies and Infectious Disease (NIAID)