Notice Number: NOT-AR-19-022
Key Dates
Release Date: October 9, 2018Estimated Publication Date of Funding Opportunity Announcement: November, 2018
First Estimated Application Due Date: March 20, 2019
Earliest Estimated Award Date: September 20, 2019
Earliest Estimated Start Date: September 30, 2019
Related Announcements
NOT-AR-19-023 Notice of Intent to Publish a Funding Opportunity Announcement for the Back Pain Consortium (BACPAC) Research Program: Data Integration, Algorithm Development and Operations Management Center (U24) (Clinical Trial Not Allowed)
NOT-AR-19-024 Notice of Intent to Publish a Funding Opportunity Announcement for the Back Pain Consortium (BACPAC) Research Program: Technology Research Sites (UH2/UH3) (Clinical Trial Optional)
NOT-AR-19-025 Notice of Intent to Publish a Funding Opportunity Announcement for the Back Pain Consortium (BACPAC) Phase 2 Clinical Trials (UG3/UH3) (Clinical Trial Required)
Issued by
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Purpose
NIAMS intends to publish a Funding Opportunity Announcement (FOA) focused on chronic low back pain research using novel, inter and multidisciplinary integrated approaches and novel analytics for discovery of disease mechanisms and features for deep patient phenotyping and identification of new targets for intervention.
This Notice is being provided to allow potential applicants enough time to develop meaningful collaborations and responsive projects.
This FOA is expected to be published in November 2018 with an expected application due date in March 2019.
This FOA will utilize the U19 activity code. Details of the planned FOA are provided below.
Public Law 115-141, the Consolidated Appropriations Act of 2018 (signed March 23, 2018) includes a requirement that grantees from for-profit applicant organizations must provide a 50% match and/or in-kind contribution of all federally awarded dollars under the grant award (direct costs, as well as facilities and administrative costs) for research related to opioid addiction, development of opioid alternatives, pain management and addiction treatment.
Matching Requirement: A grantee from a for-profit organization funded under this funding opportunity announcement must match funds or provide documented in-kind contributions at a rate of not less than 50% of the total-Federally awarded amount, as stipulated by Public Law 115-141, the Consolidated Appropriations Act of 2018.The applicant will be required to demonstrate that matching funds and/or in-kind contributions are committed or available at the time of, and for the duration of, the award. Applications must identify the source and amount of funds proposed to meet the matching requirement and how the value for in-kind contributions was determined. All matching funds and/or in-kind contributions must be used for the portion of allowable project costs not paid by Federal funds under the grant award. NIH will not be the recipient, nor serve as a pass-through entity, of any such matching funds and/or in-kind contributions required under this announcement. See 45 CFR 75.306 for additional details.
Research Initiative Details
NIH has identified a set of research priorities reflecting urgent unmet needs across the lifespan, areas of promising scientific opportunity, and concrete strategies capable of providing rapid and durable solutions to the opioid crisis including improved understanding of the biological underpinnings of chronic pain and discovery and testing of new non-addictive pain treatments.
The NIAMS intends to launch the Back-Pain Consortium (BACPAC) initiative, a patient-centric translational research program focused on chronic low back pain. Back pain is a major contributor to the use of opioids in the US. The mechanisms of low back pain are likely to be complex, with a variety of organs, tissues and cell types interacting in an environment heavily influenced by mechanical, physical, biological and biopsychosocial factors that result in the experience of pain, a decrease in physical function and in emotional and social distress. BACPAC will conduct studies that will dissect these components and mechanisms and integrate all new information to identify, prioritize and test new therapies targeted to specific mechanisms. The goal of this initiative is to probe the biomedical mechanisms of the disease in a biopsychosocial context using interdisciplinary methods and innovative technologies so that novel individualized targeted treatments can be developed, tested and combined for an integrated approach to eradicate chronic low back pain. This highly collaborative research program will conduct research to deliver an integrated model of low back pain and patient-based algorithms to facilitate the identification of treatments tailored to the individual patient.
The BACPAC Research Program consists of four primary components that will work collaboratively to achieve the goals:
- Interdisciplinary Mechanistic Research Centers (4-6) (U19s) that will conduct translational research leading to further characterization of low back pain mechanisms and improved phenotyping of patients with low back pain in clinical cohorts. Centers might conduct exploratory trials or innovative design clinical studies to obtain data for deep patient phenotyping or test new technologies.
- Technology Research Sites (3-5) UH2/UH3) that will conduct technology development and deployment.
- The Interdisciplinary Mechanistic Research Centers and the Technology Sites will interface with a Systems Biology and Informatics Core for data integration and modeling. Together the Centers, Sites and Core will explore linkages between specific structural, dynamic, cellular or molecular abnormalities to specific patient-reported symptoms and function.
- Phase 2 Clinical Trials. These trials will be conducted in two phases. A planning phase (UG3) to be carried out collaboratively within the BACPAC Consortium in consultation with the CTNPR
- (https://grants.nih.gov/grants/guide/notice-files/NOT-NS-18-058.html ,
- https://grants.nih.gov/grants/guide/notice-files/NOT-NS-18-069.html , https://grants.nih.gov/grants/guide/notice-files/NOT-NS-18-057.html ).
- The trial implementation phase (UH3) will be conducted within the CTNPR Clinical Trial environment using the CTNPR Trial Hubs, Clinical Coordinating Center and Data Coordinating Center infrastructure, services, operating and cost standards. Innovative trial designs will be used to test new non-addictive drugs, biologics, devices and complementary medicine approaches to relieve pain and improve physical function.
- A Data Integration, Algorithm Development and Operations Management Center (U24). This Center will guide and coordinate all activities of the consortium and ensure communications, interactions, synergies and accountability. It will manage a core as a Consortium-wide registry, including patient reported outcomes and preferences. Using data from clinical studies across the Consortium, this Center will develop patient-centered algorithms for prediction of optimized therapeutic interventions.
This Notice encourages investigators with expertise and insights into translational and clinical back pain research to consider organizing collaborative groups to prepare applications for the Back Pain Consortium (BACPAC) Mechanistic Research Centers (U19) FOA. Successful applicants will foster the translation of new scientific findings and technological development into better approaches for improving the lives of patients with low back pain. Each Center should focus on clinical and interdisciplinary research to understand the mechanisms of disease and rapidly translate them to low back pain classification, diagnosis, patient phenotyping and sub phenotyping, and outcome assessments to inform clinical trials.
Overall, the BACPAC Mechanistic Center research should be carried out by a multi, inter or transdisciplinary team of scientists who will address a highly significant translational research theme or challenge in low back pain. Mechanistic Research Centers will be expected to work collaboratively across the BACPAC Research Program, with extensive sharing and integration of clinical and research data across all research centers and sites.
Mandatory components:
- Research Projects and Research Cores. The focus of the research could be either 1) a disease-targeted translational theme addressed by synergistic Research Projects with optional Research Cores; or, 2) a disease-related critical challenge addressed through a single Research Project enabled by several highly interactive Research Cores whose work is integrated overtime during the development and implementation of the Project. To be successful, the Mechanistic Center must have a minimum of three highly meritorious research components consisting of one or more translational Research Projects and one or more Research Cores. The projects should be designed so that the data generated contribute directly to either an integrated model of low back pain or to improving patient phenotyping, or both.
- A Clinical Core that includes the following components:
- An ongoing low back pain cohort
- A description of current and potential capacity for phenotyping and deep patient phenotyping
- A planning project for a clinical treatment protocol to be implemented in years 2 through 5 aimed at providing patient-based treatment responses that contribute to building the phenotyping database and algorithms. Applicants will be encouraged to propose studies using alternatives to randomized controlled trial design and will include multimodal treatments.
- An Informatics and/or Systems Biology Core to support the Center activities with the option to propose to extend the services and support to the other centers and projects within the Consortium.
- An Administrative Unit
- Applicants will be expected to propose a collaborative project to test at least one specific translational or clinical hypothesis on low back pain that builds on strengths of the applicant and engage other members of the BACPAC Research Program after award. The goals should exceed the reach of a single Center and produce a greater-than-additive return. The Collaborative Project(s) will be selected and fully developed after award.
Optional Components:
- Pilot Studies to be conducted either by the Center or by the Consortium.
- Ancillary studies linked to the trials to understand biological and biopsychosocial effects of the therapies or other aspects of the disease or treatment, to identify potential biomarkers and test new outcome instruments
The lead investigators of the research components may be based in different departments, divisions and/or institutions.
Mechanistic Centers will NOT support:
- Clinical and/epidemiological research that does not include a laboratory component or capitalize upon a biological discovery relevant to human health or disease;
- Research programs that are not conducted in or include the biopsychosocial context of low back pain
- Research involving the use of animal models is not excluded; however, any proposed animal model(s) must be highly relevant to human conditions and the demonstrated application to humans must be included in the specific aims of the proposed project(s).
- Translational research focused on metastatic bone disease or low back pain due to acute or chronic infection or acute trauma.
Funding Information
Estimated Total Funding: NA
Expected Number of Awards: 4-6
Estimated Award Ceiling: NA
Primary CFDA Number: 93.846
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)
Nonprofit without 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
City or township governments
Special district 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
Applications are not being solicited at this time.
Inquiries
Please direct all inquiries to:
Back Pain Consortium (BACPAC) Research Program
National Institute of Arthritis and Musculoskeletal and Skin Diseases
[email protected]
and Human Services (HHS)
