Notice of Intent to Publish a Funding Opportunity Announcement for the NIH Common Fund Acute to Chronic Pain Signatures Program: Multisite Clinical Center Acute Pain from Musculoskeletal Trauma or Acute Peri-operative Pain (UM1 Clinical Trial Optional)

Notice Number: NOT-RM-19-010

Key Dates

Release Date:June 18, 2019
Estimated Publication Date of Funding Opportunity Announcement: September 26, 2019
First Estimated Application Due Date: November 26, 2019
Earliest Estimated Award Date: June 28, 2020
Earliest Estimated Start Date: June 28, 2020

Related Announcements

RFA-RM-18-031 

RFA-RM-18-032

RFA-RM-18-033

RFA-RM-18-034

RFA-RM-18-035

RFA-RM-19-013

Issued by
Office of Strategic Coordination (Common Fund)

Purpose

TheOffice of Strategic Coordination (Common Fund) intends to publish a funding opportunity announcement (FOA) to support one Multisite Clinical Center for the NIH Common Fund supported Acute to Chronic Pain Signatures (A2CPS) Program. Collaborative teams combining expertise in pain management and large clinical trials will be crucial to the success of the studies.

This Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and develop their approaches. The funding opportunity is expected to be published in August/September 2019 with an expected application due date at least 60 days after publication. No foreign applications or components will be allowed.

The FOA will utilize the cooperative agreement UM1 mechanism for Research Projects with Complex Structure. Details of the planned FOA are provided below.

Research Initiative Details

Rationale. A major challenge in pain management is preventing chronic pain from occurring after an acute pain event. For most people, acute pain resolves as the injury or trauma that caused it heals. Yet in many other people, acute pain from injury, surgery, or disease persists beyond the initial insult and can last for years or throughout life. In those who transition to chronic pain, maladaptive changes occur throughout the nervous system. Our lack of understanding of the mechanisms of transition to chronic pain is a major gap in knowledge that limits development of effective preventive therapies.

The ability to predict which patients are more likely to be susceptible versus resilient to the development of chronic pain is a crucial step towards the development of personalized prevention strategies, and could inform future clinical trials, improve success of trials, and transform acute pain treatment approaches for prevention of chronic pain.

A2CPS Program. Toward this end, the NIH Common Fund supported the Acute to Chronic Pain Signatures (A2CPS) Program. Awardees will work together as a consortium with strong communication and cooperation. The A2CPS program will support two longitudinal prospective studies on large cohorts of patients (two Multisite Clinical Centers (MCC)) who experience acute pain. We have an interest in surgical and especially non-surgical events that carry with them a high incidence of chronic pain. The goal of the program is to identify candidate biomarkers and combine them into biosignatures predictive of the susceptibility or resilience to the development of chronic pain. The candidate biomarkers to be tested as primary outcomes in the two studies will be selected by a panel of external experts, consortium awardees, and NIH staff, who will consider the most promising biomarkers of transition or resilience to chronic pain based on current evidence.

The new funding opportunity will support a second MCC to implement the enrollment and multimodal longitudinal assessment of a large cohort of patients with acute pain from EITHER an acute musculoskeletal trauma OR a peri-operative pain event to identify biosignatures for resilience to and/or the transition from acute to chronic pain. The MCC will recruit one homogeneous pain cohort at the onset of an acute pain event; deliver, monitor, and record usual pain care including opioid and other analgesic use; assess patients for study-determined characteristics including detailed patient reported outcomes (historical data such as previous surgeries, trauma, substance abuse, concurrent pain conditions, depression, somatization tendencies, support system, etc); perform brain imaging, sensory tests, actinography for sleep and circadian rhythms and locomotion, and collect biospecimens at onset of acute pain and follow-up (time = 0, 3 months, and 6 months).

Funding for A2CPS will come from the NIH Common Fund, which supports cross-cutting programs expected to have exceptionally high impact. All Common Fund initiatives invite investigators to develop bold, innovative, and often risky approaches to address problems that may seem intractable or to seize new opportunities that offer the potential for rapid progress. A2CPS is a HEAL-related Initiative. The HEAL (Helping to End Addiction Long-term) Initiative is an aggressive effort to speed scientific solutions to stem the national opioid public health crisis (https://www.nih.gov/research-training/medical-research-initiatives/heal-initiative).

Funding Information

Estimated Total Funding Estimated Total Funding - TBD
Expected Number of Awards TBD
Estimated Award Ceiling TBD
Primary CFDA Numbers 93.310

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)
Regional Organization
Applications are not being solicited at this time. 

Inquiries

Please direct all inquiries to:

Linda Porter, Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS)
301-435-7572
porterl@ninds.nih.gov