Notice Number: NOT-AR-19-024

Key Dates

NOT-AR-19-023 Notice of Intent to Publish a Funding Opportunity Announcement for the NIH Back Pain Consortium (BACPAC) Research Program: Data Integration, Algorithm Development and Operations Management Center (U24) (Clinical Trial Not Allowed)

NOT-AR-19-025 Notice of Intent to Publish a Funding Opportunity Announcement for the Back Pain Consortium (BACPAC) Research Program: 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 focused on development, testing and deployment of novel, rapid and scalable technologies and methods for diagnosis, phenotyping and sub-phenotyping of patients with chronic low back pain and for evaluation and prediction of likelihood of treatment response. The technologies will enable and synergize with 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 carried out in other components of the BACPAC Research Program.

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 UH2/UH3 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 Clinical Trials Network on Pain Research (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 chronic 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 technologies, methodologies and approaches that are or could be potentially be applicable to improve understanding, diagnosis and treatment of chronic low back pain to consider organizing teams to prepare applications for the Back Pain Consortium (BACPAC) Research Program Technology Research Sites (UH2/UH3) FOA. Successful applicants will foster the development of advanced technologies and tools that will enable the interrogation of organs, tissues and pathways involved in low back pain.

Overall, a BACPAC Technology Research Site work could be carried out by a multi, inter or transdisciplinary team of scientists who will address a highly significant technology research challenge in back pain. Technology 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.

Applicants will propose a project within one of the following four technology development phases:

(I) Exploratory Research for Technology Development: High risk and high reward exploration of possible approaches to develop- a potential technology. This is preliminary research that, if successful, should lead to proof-of-concept: a preliminary demonstration of feasibility. The project should be responsive to an unmet need or emerging opportunity in low back pain research. Preliminary data are not required.
(II) Focused Technology Research and Development: Projects characterized by innovative research and development, focused on addressing technical challenges that stand in the way of creating an effective research tool for low back pain research. Projects are supported by preliminary data demonstrating feasibility of the approach.
(III) Iterative Technology Research and Development: These projects are characterized primarily by the close coupling of technology development with the application of emerging technologies to biomedical projects that serve as test-beds. Technology are at a stage in which they can be tested in research for continued development and improvement.
(IV) Research and Development for Technology Optimization: Refinement of existing technologies with strong potential for biomedical impact, to make them transferrable to other research and clinical sites participating in the BACPAC Mechanistic Network and Clinical Trial sites. The work can be completed concurrently with prior stages of technology development.

The Projects will be phased for development based on peer review and programmatic assessment. The awards made under the planned FOA will initially support up to a two-year milestone-driven phase (UH2), with possible transition to an implementation phase of up to 3 years (UH3). Only UH2 projects that have met the scientific milestones and feasibility requirements and are deemed high priority may transition to the UH3 phase. The UH2/UH3 application will be submitted as a single application, specific instructions will be provided in the FOA. The Technology Project implementation phase (UH3) will be conducted collaboratively with other components of the BACPAC Mechanistic Network.

Technologies can be developed and tested for application to diagnosis, treatment and prevention of low back pain or to facilitate the discovery of mechanisms of disease. Areas of interest include, but are not limited to, the following:

Wearable technologies to target peripheral and central pathways involved in low back pain and to counter decreases in physical function and disability to inform clinical treatment.
Sensor-driven, implantable devices to target peripheral pain pathways, or to monitor/track alterations in either structure or function of cells, molecules, tissues and organs involved in low back pain.
Modeling and development of in vitro, three-dimensional human tissue that mimic in vivo tissue architecture and physiological conditions to facilitate and accurately monitor key organ-level functions of low back pain.
Integration of analyses of different tissues to produce a multi-scale, possibly kinematic 3D model of how abnormalities in fascia, muscle, bone, etc., interact to produce abnormal function and pain.
Clinical non-invasive or minimally invasive assessment and/or imaging tools to precisely locate pain-related neural circuits to aid use of next-generation neurotherapeutic devices by identifying targets for intervention.

Optional Components:

A clinical trial to be conducted in a UG3/UH3 like phased fashion.
A collaborative project linked to clinical trials conducted elsewhere in the Research Program using the technology under development to explore a mechanism of disease.

Technology Site awards will NOT support:

Biomarker discovery or validation
Development of new drugs
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).
Technology development focused on metastatic bone disease or low back pain due to acute or chronic infection or acute trauma

Funding Information

Estimated Total Funding Estimated Total Funding: N/A
Expected Number of Awards up to 4
Estimated Award Ceiling Estimated Award Ceiling: N/A
Primary CFDA Numbers 93.846

Anticipated Eligible Organizations

Inquiries

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