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  • Jan 16, 2020

Funding Opportunity: TIN HEAL Initiative: Pain Management Multisite Effectiveness Research Network (ERN)

The NIH will re-release RFA-NS-19-021 (UG3/UH3) on January 20, 2020 with an expected submission deadline on March 24, 2020 and GHUCCTS Trial Innovation Network Hub Liaison Team is here to help facilitate the process.

Through this re-release, HEAL Initiative: Pain Management Multisite Effectiveness Research Network (ERN): Clinical Trial Planning and Implementation Cooperative Agreement (UG3/UH3 Clinical Trial Required), NIH is soliciting up to two additional ERN trials that will address the high priorities below. NIH 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:

  • pain management in emergency departments, dental clinics, primary care, and hospitals;
  • chronic overlapping pain conditions;
  • best practices for effective analgesics when appropriate;
  • pain management in individuals at risk of or with OUD;
  • pain management in those with co-occurring mental health disorders; and
  • Non-cancer pain management in persons with medical comorbidities

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.

This multisite effectiveness research consortium will be part of the NIH’s Helping to End Addiction Long-term (HEAL) initiative to speed scientific solutions to the national opioid public health crisis. The NIH HEAL Initiative will bolster research across NIH to (1) improve treatment for opioid misuse and addiction and (2) enhance pain management. This broad research effort seeks to improve pain care through understanding the development of chronic pain and by accelerating and improving the process of therapy development to more rapidly move discoveries into clinical practice to alleviate the burden of pain. More information about the HEAL Initiative is available at: https://www.nih.gov/research-training/medical-research-initiatives/heal-initiative.

Process for Identifying Additional Sites

  • Determine number of participants to be enrolled.
  • Determine number of potential participants at applicant’s institution and institutions of any co-investigators.
  • Identify HEAL Point of Contacts (POC) at individual CTSA hubs to determine size of potential cohorts (see trialinnovationnetwork.org or contact emily.p.paku@medstar.net who can facilitate this process).
  • Determine whether CTSA hub wishes to participate in the trial (see next slide) and ask for a letter of intent for application.
Trial Innovation Network (TIN) Resources 

TIN will provide these resources to all awardees (no letter of support needed): 

  • Single IRB services for the trial; 
  • Assistance with execution of the Master Clinical Trial Agreements with clinical sites; 
  • Developing final study protocol with study team; 
  • Finalizing recruitment and retention plans with investigators before trial initiation; 
  • Providing support for study design, statistical analyses and interpretation of results for manuscripts and publications; 
  • Developing associated trial documents, e.g., 
    • Manual of Procedures 
    • Standard Operating Procedures 
    • Case report forms 
    • Training materials for study personnel 
  • Training clinical site investigators and staff for individual trials.
    • Training areas include, but are not limited to, regulatory requirements, Good Clinical Practice (GCP), adverse event reporting, human subject protections, informed consent, and NIH policies and procedures
Budget

Estimated Total Funding: $800,000 total costs for FY2020; $2,000,000 total costs per year for FY2021, FY2022, FY2023, FY2024
Expected Number of Awards: 2

Estimated Award Ceiling: 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.

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.
Visit our Trial Innovation Network page for more information.

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