Notice of Intent to Publish a Funding Opportunity Announcement for TMD Collaborative for IMproving PAtient-Centered Translational Research (TMD IMPACT) (U54 Clinical Trial Optional)
Notice Number:
NOT-DE-25-029

Key Dates

Release Date:
June 17, 2024
Estimated Publication Date of Notice of Funding Opportunity :
August 30, 2024
First Estimated Application Due Date:
December 13, 2024
Earliest Estimated Award Date:
July 01, 2025
Earliest Estimated Start Date:
July 01, 2025
Related Announcements

None

Issued by

National Institute of Dental and Craniofacial Research (NIDCR)

Purpose

The National Institute of Dental and Craniofacial Research (NIDCR), together with numerous partners, intends to promote a new initiative by publishing a Notice of Funding Opportunity (NOFO) to solicit applications for research on the Temporomandibular Disorder (TMD) Collaborative for Improving Patient-Centered Translational Research (TMD IMPACT). The purpose of TMD IMPACT is to establish a national, interdisciplinary, patient-centered research collaborative that will advance TMD basic and clinical research, research training, and translation to evidence-based treatments and improved clinical care. The TMD IMPACT Collaborative will be comprised of one or more center(s) designed to coordinate and leverage shared resources, expertise in, and collaboration across multiple topic areas and interdisciplinary teams. The key objectives of the TMD IMPACT Collaborative are to:

  1. Support robust and rigorous TMD basic research that leads to clinically relevant insights and mechanistic understanding;
  2. Develop translational programs and support clinical research to improve diagnosis, prevention, and treatment of the various TMDs to ultimately improve standard of care;
  3. Strengthen population-based research on the public health burden and costs of TMDs to improve prevention and management of TMDs, and health services and implementation research to improve quality and access to care; and
  4. Train the next generation of interdisciplinary TMD researchers that represent diversity of backgrounds, career stages, and disciplines.

This Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects. The NOFO is expected to be published in Summer 2024 with an expected application due date in Winter 2024. This NOFO will utilize the U54 activity code. Details of the planned NOFO are provided below.

Research Initiative Details

This Notice encourages investigators with expertise and insights into this area of Temporomandibular Disorder (TMD) to begin to consider applying for this new NOFO.

The research framework of the TMD IMPACT Collaborative is interdisciplinary, addressing TMD-related research questions that single independent research projects could not address and covering a broad swath of the translational spectrum. Research topic priorities and approaches of the TMD IMPACT Collaborative include:

  • Stratification of patients into clinically meaningful and mechanistically based subgroups, and identification and validation of etiological targets for diagnosis, treatments, or their clinical endpoints, including any sex and/or gender differences.
  • Research focused on discerning mechanisms of molecular pathogenesis, disease progression, or resilience that correlate with stratification approaches and TMD clinical heterogeneity; as well as mechanisms that sustain or promote endogenous resolution of chronic TMD pain and/or prevent the transition from acute to chronic pain.
  • Development of minimally invasive treatments and therapies (e.g., force-based manipulations, dry needling, thermotherapies, and local chemical injections) and/or strengthening their evidence-base; and symptom management using biobehavioral approaches.
  • Systems biology, whole-organ, and whole-person approaches that include biopsychosocial mechanisms and consider mental health comorbidities, affective influences on pain, and chronic overlapping pain conditions (e.g., headache, mixed musculoskeletal or myofascial pain).
  • Innovative approaches that enhance our mechanistic understanding of sex and gender differences in incidence, pathophysiology, and pain chronification and resolution. predisposes females more than males to develop a TMD.
  • Biomechanical, tissue engineering, biomaterial, and regeneration studies.
  • Adaptation and utilization or development of new tools, imaging, devices, and technologies to facilitate access to the TMJ and the unique orofacial physiology, advance current standards of detection and measurement, and for therapeutic applications.
  • AI/ML/DL and computational methods (e.g., statistical modeling, natural language models, etc.) to leverage large datasets for purposes such as integration of data from various animal models, developing knowledge maps, distinguishing disease subtypes, developing individualized clinical decision support, and predicting patient responses.
  • Strengthening the evidence-base for existing pharmacological and non-pharmacological treatments, including mechanistic studies, efficacy trials, pragmatic trials, and comparative effectiveness trials.

It is not expected that each center will include all of the above. The proposed research projects should be coordinated and synergistic to address TMD comprehensively from the whole-person perspective that goes beyond what single projects would be capable of.

TMD IMPACT Collaborative Elements

Each TMD IMPACT Center application (U54) must include the following elements:

  1. Administrative Core (AC)
  2. Outreach, Training, and Education Core (OTEC)
  3. Bioinformatics/data science Core (BDSC)
  4. One to three Research Projects

Funding Information

Estimated Total Funding

$7 million in FY2025

Expected Number of Awards

2

Estimated Award Ceiling

$3.5 million total costs including F&A consortium costs

Primary Assistance Listing Number(s)

93.121 

Anticipated Eligible Organizations
Public/State Controlled Institution of Higher Education
Private Institution of Higher Education
Nonprofit with 501(c)(3) IRS Status (Other than Institution of Higher Education)
Small Business
For-Profit Organization (Other than Small Business)
State Government
Indian/Native American Tribal Government (Federally Recognized)
County governments
Independent school districts
Public housing authorities/Indian housing authorities
Indian/Native American Tribally Designated Organization (Native American tribal organizations (other than Federally recognized tribal governments)
U.S. Territory or Possession
Indian/Native American Tribal Government (Other than Federally Recognized)
Non-domestic (non-U.S.) Entity (Foreign Organization)
Regional Organization
Eligible Agencies of the Federal Government

Applications are not being solicited at this time. 

Inquiries

Please direct all inquiries to:

Melissa Ghim, PhD
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-529-6570
Email: melissa.ghim@nih.gov

Jason Wan, PhD
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-594-9898
Email: jasonwan@mail.nih.gov