Notice Number: NOT-AR-19-023

Key Dates

Issued by

Purpose

NIAMS intends to publish a Funding Opportunity Announcement (FOA) soliciting applications to provide research and services related to translational and clinical data integration and analysis, algorithm development and testing, operation of a patient reported outcomes and preferences core and overall management of the operations 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 U24 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

The NIAMS intends to launch the Back-Pain Consortium (BACPAC) initiative, a patient-centric translational research program focused on chronic low back pain as a component of the NIH HEAL Initiative. 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 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 (CCC) and Data Coordinating Center (DCC) 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 develop patient centered algorithms, manage a registry and a patient reported outcomes and patient preference core.

The U24 awardee will provide a broad range of support critical for the design, development, implementation, monitoring and analysis of translational and clinical research carried out by the BACPAC Mechanistic Network and the BACPAC Clinical Trials. The scientific and operational support for the BACPAC Consortium will be provided in the following areas: clinical data integration/patient registry, study design, statistical analysis, protocol development, study initiation and management, clinical site monitoring, and safety monitoring, and patient-reported outcomes/patient preferences. Center applications will include group of experts specifically focused on developing patient-based data algorithms, adaptive and other study designs and approaches to integration of clinical data to accelerate the use of new information generated by the Consortium in the development and implementation of algorithms and clinical trial trials. The Center will work closely with the BACPAC Consortium Systems Biology/Informatics Core to integrate laboratory and clinical data for the development of patient algorithms. BACPAC Research Program activities to be supported by the proposed center include clinical trials, integrated studies of underlying mechanisms, clinical studies (e.g., longitudinal studies, genetic studies, etc.). Services to BACPAC clinical trials will be limited to those not expected to be supported by the CTNPR. The Center will lead and coordinate BACPAC Research Program interactions with the CTNPR CCC and DCC.

Funding Information

Estimated Total Funding Estimated Total Funding: N/A
Expected Number of Awards Expected Number of Awards: up to 2
Estimated Award Ceiling Estimated Award Ceiling: N/A
Primary CFDA Numbers 93.846

Anticipated Eligible Organizations

Inquiries

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