Notice Number: NOT-AR-19-025
Key Dates
Release Date: October 09, 2018Estimated Publication Date of Funding Opportunity Announcement: November 21, 2018
First Estimated Application Due Date: February 18, 2019
Earliest Estimated Award Date: September 20, 2019
Earliest Estimated Start Date: September 30, 2019
Related Announcements
NOT-AR-19-022 Notice of Intent to Publish a Funding Opportunity Announcement for Back Pain Consortium (BACPAC) Research Program: Mechanistic Research Centers (U19) (Clinical Trial Optional)
NOT-AR-19-023 Notice of Intent to Publish a Funding Opportunity Announcement for Back Pain Consortium (BACPAC) Research Program: Data Integration, Algorithm Development and Operations Management Center (U24) (Clinical Trail 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)
Issued by
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Purpose
NIAMS intends to publish a Funding Opportunity Announcement (FOA) soliciting clinical trial applications focused on new and improved diagnostic and treatment modalities for chronic low back pain. The clinical trials will be supported in two phases, a milestone driven planning phase (UG3) and an implementation phase (UH3). Conduct of the study will be carried out at the Clinical Trial Network on Pain Research (CTNPR) Clinical Sites. CTNPR will also provide Data Management and Clinical Coordination support during the conduct of the trials and consultative services during the planning phase.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 UG3/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 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 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 CNTPR Clinical Trial environment using the CTNPR Trial Hubs, Clinical Coordinating Center (CCC) and Data Coordinating Center (DCC) infrastructure, services, operating and cost standards. Innovative trials 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). T 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 back pain and clinical trials to consider organizing teams to prepare applications for the Back Pain Consortium (BACPAC) Research Program: Phase 2 Clinical Trials (UG2/UG3) FOA. Successful applicants will lead the design, and organization of the chronic low back pain clinical trial during the UG3 Planning Phase, working collaboratively with other components of BACPAC and within the environment and support of CTNPR CCC and DCC. The awards made under the planned FOA will initially support a one-year milestone-driven planning phase (UG3), with possible transition to a clinical trial implementation phase of up to 3 years (UH3). Only UG3 projects that have met the scientific milestones and feasibility requirements and are deemed high priority may transition to the UH3 phase. The UG3/UH3 application will be submitted as a single application, specific instructions will be provided in the FOA.
Areas of interest include:
Appropriate trials may test novel drugs, biologics, devices, natural products, surgical, or non-pharmacological interventions. While trials in the CTNPR will be hypothesis driven, not descriptive observational studies, the CTNPR CCC and DCC will oversee the collection and analysis of data through a CTNPR Registry.
Clinical trials may include but are not limited to:
Phase 2 studies testing safety and efficacy of therapeutic candidates, including pharmacologics, biologics, and medical devices.
Adaptive design and other novel design approaches to improve the value, quality, rigor, duration, and cost of the trials are encouraged.
Novel designs paired with advanced diagnostic, imaging and robust outcome assessments and fully integrated mechanistic studies.
Trials with adaptive and other designs to determine the efficacy of integrated physical, behavioral, pharmacologic and electrical stimulation interventions and to explore the patient characteristics that may account for their relative outcomes.
Trials with linked mechanistic studies to identify patient characteristics and outcomes of interventions that enable tailoring of interventions to the underlying pathophysiology of disease.
Trials testing and validating newly developed algorithms for individualized treatment protocols that incorporate combination therapies.
Optional Components:
Pilot Studies to be conducted either by the Site or by the Consortium.
Ancillary studies linked to the proposed 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 outcomes instruments.
Clinical Trial Planning Phase (UG3)
The UG3 grant award will provide one year of support for finalizing the protocol and preparing other documents to implement the clinical trial. The UG3 award is not designed for the collection of preliminary data (either clinical or pre-clinical animal studies) about the efficacy of an intervention, or the collection of prospective data to support the rationale for a clinical trial. Planning activities such as evaluating the potential study population to determine the number of subjects at a site that would fulfill eligibility criteria for the UH3 trial are allowed.
Examples of activities supported during the UG3 phase include, but are not limited to, developing the following:
A final clinical protocol;
The Manual of Procedures (MOP);
The final statistical analysis plan;
The consent form(s) and, if applicable, assent form(s);
The Clinical Investigators Brochure (IB) or equivalent, if applicable;
A plan for the administration of study agent(s), if applicable;
Detailed description of Roles and Responsibilities of study personnel;
The final quality management and data management plans; and
Strategies to put in place should enrollment or retention for follow up not meet specified metrics.
Clinical Trial Implementation Phase (UH3):
The objective of the year 2 to year 5 UH3 implementation phase is to conduct the clinical trial in accordance with activities planned in the UG3 phase. The trial outcome measure(s) must be clinically meaningful and important to stakeholders including patients and health care providers. The NIAMS expects clinical trials supported during the UH3 phase to be hypothesis driven, milestone-defined, and have the potential for high impact in chronic low back pain treatment. The clinical trial must meet all applicable NIH, Food and Drug Administration (FDA), and Office of Human Research Protections (OHRP) policy requirements.
Milestones and UG3/UH3 Transition
Projects must be driven by well-defined milestones for the planning phase (UG3) and annual milestones for the clinical trial implementation phase (UH3). It is understood that the proposed milestones for the UH3 phase may be revised as activities in the UG3 phase progress. In the event of an award, the PD/PI and NIH will negotiate a final list of milestones for each year of support.
Applications that propose multi-site studies with multiple domestic sites are subject to the new NIH Single IRB policy as indicated in NOT-OD-16-094.
Clinical Trial awards will NOT support:
Biomarker discovery or validation
Clinical trials that are not conducted in or include the biopsychosocial context of low back pain
Trials focused on treatment of 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
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)
Regional Organization
Applications are not being solicited at this time.
Inquiries
Please direct all inquiries to:
and Human Services (HHS)
