Notice of Intent to Publish a Funding Opportunity Announcement for HEAL Pain Effectiveness Research Network: Clinical Trial Planning and Implementation Cooperative Agreement (UG3/UH3 Clinical Trial Required)

Notice Number: NOT-NS-19-022

Key Dates

Release Date:November 27, 2018
Estimated Publication Date of Funding Opportunity Announcement: December 18, 2018
First Estimated Application Due Date: February 01, 2019
Earliest Estimated Award Date: June 01, 2019
Earliest Estimated Start Date: July 01, 2019

Related Announcements
None

Issued by
National Cancer Institute (NCI)
National Eye Institute (NEI)
National Institute on Aging (NIA)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute of Dental and Craniofacial Research (NIDCR)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institute on Drug Abuse (NIDA)
National Institute of Mental Health (NIMH)
National Institute on Minority Health and Health Disparities (NIMHD)
National Institute of Neurological Disorders and Stroke (NINDS)
National Institute of Nursing Research (NINR)
National Center for Advancing Translational Sciences (NCATS)
National Center for Complementary and Integrative Health (NCCIH)
Office of Behavioral and Social Sciences Research (OBSSR)

Purpose

In April 2018, the National Institutes of Health (NIH) launched the HEAL (Helping to End Addiction Long-term) Initiative, an aggressive, trans-agency effort to speed scientific solutions to stem the national opioid public health crisis. In response to this initiative, the National Institute of Neurologic Disorders and Stroke and the National Center for Advancing Translational Sciences, in partnership with other NIH Institutes and Offices, will solicit applications that propose clinical trials to test the comparative effectiveness of existing therapies or effectiveness of novel approaches for prevention and management of pain while reducing risk of addiction. The studies must address questions within the mission and research interests of participating NIH Institutes and Centers and evaluate preventive strategies or interventions including medications, biologics, procedures, medical and assistive devices and technologies, diagnostic testing, behavioral change, rehabilitation strategies, complementary therapies, integrated approaches, and delivery system strategies in well controlled trials in specific pain conditions. The overall goal is to inform clinicians about the effectiveness of interventions or management strategies that reduce opioid use that will improve functional outcomes and reduce acute to chronic pain associated with many types of diseases or conditions, or pain presenting as a disease itself. Clinical trials will be conducted within the infrastructure of the HEAL Pain Effectiveness Research Network.

This Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects. The FOA is expected to be published in Winter 2018 with an expected application due date in early 2019 and will utilize the UG3/UH3 activity code. Details of the planned FOA are provided below.

Research Initiative Details

Description

The planned request for applications (RFA) will support effectiveness clinical trials that propose clinical trials to test the comparative effectiveness of existing therapies or effectiveness of existing or novel approaches for prevention and management of pain while reducing risk of addiction. The overall goal is to inform clinicians about the effectiveness of interventions or management strategies that reduce opioid use that will improve functional outcomes and reduce pain across the continuum of acute to chronic pain associated with many types of diseases or conditions, or pain presenting as a disease itself. 

This Notice encourages investigators with expertise this area of clinical research to consider applying to this planned FOA. Collaborative teams combining expertise in pain management and large clinical trials will be crucial to the success of the studies.  The planned initiative will encourage UG3/UH3 phased cooperative research applications to conduct efficient, large-scale effectiveness trials to evaluate non-addictive therapies for pain that would reduce use of opioids. Awards will support a one-year milestone-driven planning phase (UG3), with transition to an implementation phase (UH3) of up to four years, contingent on meeting milestone and feasibility requirements of the planning phase. The UG3/UH3 application must be submitted as a single application.

Overview of the HEAL Pain ERN Network

Awardees will be required to conduct their studies through the NIH HEAL Pain Effectiveness Research Network (HEAL Pain ERN), which will have dedicated pain and clinical trial design expertise.  The HEAL Pain ERN will use the infrastructure of the NCATS Trial Innovation Network (TIN) ( https://trialinnovationnetwork.org/ ) to provide scientific guidance and coordination of the HEAL Pain ERN trials. The TIN will work with the broad consortium of Clinical and Translational Science Awards (CTSA) hubs ( https://ctsa.ncats.nih.gov/ ) and other sites identified by awardees to implement studies. The TIN investigators will work with UG3/UH3 awardees during the planning and implementation phases, and will provide clinical coordination center (CCC) services, data coordination center (DCC) services, recruitment and retention services, and biostatistical support.

Background

Reducing the burden of pain nationwide is a significant unmet need, and individuals need safe, non-addictive treatments to alleviate pain.  The strength of evidence for the effectiveness of current strategies currently used to manage pain is often low to moderate (CDC Guideline for Prescribing Opioids for Chronic Pain, AHRQ Noninvasive, Nonpharmacological Treatment for Chronic Pain - A Systematic Review). These strategies include some non-pharmacologic treatments for specific chronic pain conditions, long-term opioid therapy and different methods to initiate and titrate opioids.  More studies also are needed to inform evidence-based non-opioid treatments in the peri-operative setting .

The Federal Pain Research Strategy is a long-term strategic plan to guide the federal agencies and departments that support pain research and to advance the science to better understand pain and improve pain care.  The strategy includes several priority recommendations on effectiveness research for pain. For further information on these programs see:https://www.painconsortium.nih.gov/Funding_Research/Funding_Opportunities  

 

Research Objectives

The planned request for applications for clinical “effectiveness” research for management of pain in ways that reduce the risk of addiction. Effectiveness research is defined as the conduct and synthesis of research comparing the benefits and harms of different interventions and strategies to prevent, treat and monitor pain conditions in “real world” settings. The purpose of this research is to improve functional health outcomes by developing and disseminating evidence-based information to patients, clinicians, and other decision-makers, responding to their expressed needs, about which interventions are most effective for which patients under specific circumstances.  To provide this information, comparative effectiveness pain research must assess a comprehensive array of health-related outcomes for diverse patient populations and subgroups. Defined interventions to be tested in controlled trials may include medications, biologics, procedures, medical and assistive devices and technologies, diagnostic testing, behavioral change, complementary approaches, rehabilitation strategies, integrated approaches, and deliver system strategies. 

The planned request for applications will not accept applications that propose testing of interventions to establish initial efficacy of drugs, devices or biologics for approval by the FDA.

Many NIH Institutes, Centers and Offices share the goal to alleviate pain through support of clinical research to develop and evaluate interventions and approaches to alleviate pain in ways that reduce the risk of addiction. Applications of interest include:

  • Trials to address the weak evidence for the efficacy of different classes of analgesics to manage acute and post-operative pain in all populations after minor and major surgical procedures;
  • Trials to establish methods that translate efficacious non-opioid interventions for management of acute or chronic pain conditions into effective therapies that can be delivered successfully in rural settings;
  • Comparative effectiveness trials of mind and body approaches for specific pain conditions, such as low back pain, fibromyalgia, osteoarthritis and headache. This could include helping individuals manage pain and/or studies that assess effective contributions of family/caregivers in managing pain;
  • Trials to prevent or treat acute and chronic nociceptive and neuropathic pain and clinical trials designed to compare effectiveness of non-opioid analgesics and devices, either alone or in novel combinations;
  • Trials that assess the effectiveness of interventions that reduce pain and disparities in pain management in health disparity populations;
  • Trials that determine effective interventions for persistent pain in older adults in ways that maximize function, minimize pain’s interference with life, and/or mitigate pain treatment interactions with underlying aging processes, co-occurring conditions, and medications;
  • Trials testing methods to prevent or manage persistent pain in ways that maximize function and minimize pain’s interference with life for the following conditions:
    • Gynecologic pain syndromes;
    • Acute and chronic cancer related pain syndromes caused by the disease or its treatment; 
    • Pain associated with diabetic neuropathy, Inflammatory Bowel Disease, pancreatitis, hepatitis, cholecystitis and choledocholithiasis, Irritable Bowel Syndrome, functional abdominal pain and other functional gastrointestinal disorders, urologic chronic pelvic pain syndrome, and kidney stone disease;
    • Pain associated with temporomandibular joint disorders (TMD), trigeminal neuropathies, burning mouth syndrome, oral cancer, and dental pathologies.
    • Chronic sickle cell disease pain.
    • Acute or chronic pain in children.
    • Acute or chronic pain and co-occurring mental health symptoms and disorders.
  • Trials testing clinical tools and/or interventions designed to modify practitioner opioid prescribing behaviors;

Funding Information

Estimated Total Funding NIH intends to fund approximately five awards, corresponding to a total of $13,800,000 total costs for fiscal year 2019 and $25,800,000 total costs for each fiscal year 2020 to 2023.
Expected Number of Awards 5
Estimated Award Ceiling TBD
Primary CFDA Numbers 93.853

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:

Linda Porter, Ph.D
National Institute Neurological Disorders and Stroke (NINDS)

301-435-7572
porterl@ninds.nih.gov

Institute contacts:

Jane C. Atkinson, DDS

National Center for Advancing Translational Sciences (NCATS)

Telephone: 301-827-6031

Email: jatkinso@mail.nih.gov

 

Lanay Mudd, PhD

National Center for Complementary and Integrative Health (NCCIH)

Telephone: 301-594-9346

Email: lanay.mudd@nih.gov

 

Diane St. Germain, RN, MS, CRNP

National Cancer Institute (NCI)

Telephone: 240-276-7050

Email: dstgermain@mail.nih.gov

 

Lisa Onken, PhD

National Institute on Aging (NIA)

Telephone: 301-496-3136

Email: lisa.onken@nih.gov

 

Soundar Regunathan, PhD

National Institute on Alcohol Abuse and Alcoholism National Institutes of Health (NIAAA)

Telephone: 301-443-1192

Email: soundar.regunathan@nih.gov

 

Chuck Washabaugh, PhD

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Telephone: 301-594-5055

Email: washabac@mail.nih.gov

 

Susan Marden, PhD, RN

National Center for Medical Rehabilitation Research

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Telephone: 301-435-6838

Email: mardens@mail.nih.gov

 

Dena Fischer, DDS, MSD, MS

National Institute of Dental and Craniofacial Research (NIDCR)

Telephone: 301-594-4876

Email: dena.fischer@nih.gov

 

Jose Serrano MD, PhD

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Telephone: 301-594-8871

Email: js362q@nih.gov

 

Eve E. Reider, PhD

National Institute of Mental Health (NIMH)

Telephone: 301-827-1496

Email: ereider@mail.nih.gov

 

Andrew Louden, PhD

National Institute on Minority Health and Health Disparities (NIMHD)

Telephone: 301.594.9009

Email: Andrew.louden@nih.gov

 

Jeremy Brown, MD

National Institute for Neurological Disorders and Stroke (NINDS)

Telephone: 301-827-8375

Email: Jeremy.brown@nih.com

 

Lois A. Tully, PhD

National Institute of Nursing Research (NINR)

Telephone: 301-594-5968

Email:  tullyla@mail.nih.gov