National Institute on Alcohol Abuse and Alcoholism (NIAAA)
National Institute of Dental and Craniofacial Research (NIDCR)
National Institute on Drug Abuse (NIDA)
National Institute of Nursing Research (NINR)
National Institute on Minority Health and Health Disparities (NIMHD)
National Center for Complementary and Integrative Health (NCCIH)
National Center for Advancing Translational Sciences (NCATS)
National Cancer Institute (NCI)
The purpose of this Notice is to inform potential applicants that the National Institute of Neurological Disorders and Stroke (NINDS) intends to publish a re-issuance of funding opportunity announcement RFA-NS-19-021 to solicit applications for clinical trial planning and implementation to generate evidence-based pain management best practices for the use of existing medications or devices for specific pain conditions.
This Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects.
The funding opportunity announcement is expected to be published in December 2019 with an expected application due date in March 2020. Applicant organizations may submit more than one application, provided each application proposes a distinct clinical trial.
This funding opportunity announcement will utilize the UG3/UH3 bi-phasic activity code.
Most chronic pain management is delivered in the primary care settings where providers have few evidence-based guidelines to support their clinical decisions. Acute pain management often is delivered in emergency departments, hospital settings or dental clinics where reliance on treatment with opioids increases risks for Opioid Use Disorder (OUD). Adults with pain due to injury, neck and back pain, abdominal pain or headache make up over 33 million ER visits per year. . Evidence for best pain care practices in these settings are lacking, not only for acute pain relief, but also for prevention of chronic pain and OUD. In addition, quality, precision pain care following surgical or other procedures with medications including opioids and other pharmacological therapies and devices would provide a more robust evidence base to guide providers in these settings, would promote tailored acute pain care, and reduce reliance on opioids.
This re-release HEAL Initiative: Pain Management Effectiveness Research Network: Clinical Trial Planning and Implementation Cooperative Agreement (UG3/UH3 Clinical Trial Required) will prioritize the following areas of interest to generate evidence-based pain management best practices for the use of existing medications or devices for specific pain conditions. The guidelines should be of use to providers in primary care, emergency departments, dental clinics, and hospital settings. The pain conditions of high priority are:
Research testing behavioral interventions to manage pain will not be considered as high priority projects since several currently funded HEAL trials are testing behavioral interventions for pain management. Investigators wishing to test the effectiveness of behavioral interventions should contact program officials from individual ICs to find an appropriate FOA. Research testing software or decision-making tools that help providers and patients determine the most effective and safe methods for pharmacological or device pain management are allowed.
$800,000 total costs for FY2020; $2,000,000 total costs per year for FY2021, FY2022, FY2023, FY2024
Up to $500,000 direct cost for the one-year UG3 phase and up to $1,000,000 per year direct cost for the UH3 phase for no more than 4 years. Note that the Trial Innovation Network will provide infrastructure including the data management system, clinical coordination, and support for trial document development such as the manual of procedures. These costs should not be included in the UG3/UH3 budgets.
Linda L. Porter, Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS)
301-435-7572
porterl@ninds.nih.gov
Jane C. Atkinson, DDS
National Center for Advancing Translational Sciences (NCATS)
Telephone: 301-827-6031
Email: jatkinso@mail.nih.gov