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September 2019|December 2019

Welcome and Update - Walter Koroshetz, NINDS

Dr. Koroshetz opened the meeting and provided an update on the NIH HEAL Initiative. Proposals were submitted by the clinical and preclinical teams and the HEAL executive committee made the decision on the proposals.  In 2021, there will be HEAL funds and it’s anticipated that the teams will play a larger role in concept development.

Teams put together proposals for 2020 and the HEAL Exec. Committee made decisions on funding. The selected proposals covered HEAL focus areas including:

  • Preclinical and translational research in pain management, and Clinical research in pain management
  • New strategies to prevent and treat opioid addiction, translation of research to practice for the treatment of opioid addiction, and Novel medication options for OUD and overdose
  • Enhanced outcomes for infants and children exposed to opioids

Groups should begin preparing for 2021 funds now so that teams take on a bigger roll to come up with ideas. The pain groups will need to work hard to ensure balance between pain and addiction projects.

HEAL Update:  For upcoming proposals, preliminary concepts will be due by 12/30/2019 in time to go to Jan/Feb 2020 council. Mature concepts will go to OD in late February. In March, the HEAL multi-disciplinary working group will provide feedback on concepts so that the HEAL exec. Committee can make final decisions in April. If a workshop was approved for 2020, extra funds may be available if a supplemental proposal is submitted.

HEAL PRISM (Pragmatic and Implementation Studies for the Management of Pain) and ERN (Pain Management Effectiveness Research Network) RFAs have been re-issued. Four PRISM trials and Four ERN trials, plus two supplements are currently funded.

ERN goals include: comparative effectiveness research on existing therapies or novel approaches for delivering current therapies to prevent and manage pain while reducing risk of addiction; strengthen and inform current guidelines for pharmacologic and non-pharmacologic treatments for acute and chronic pain conditions in people from diverse communities; provide patients & practitioners with a suite of effective strategies to alleviate pain and reduce reliance on opioids; and improve quality of life for affected patients and their families.

The PRISM program studies the integration of interventions with demonstrated efficacy for pain treatment into health care delivery with partnering health care systems, or to study the implementation of health care system changes to improve adherence to evidence-based pain management guidelines.
The PRISM NOFO requires that the intervention be embedded into three or more health care systems, and should use pragmatic methods (e.g., clinic level randomization, primary use of electronic health care record data, no or unobtrusive adherence monitoring, etc.). Awardees will become part of the NIH Health Care System (HCS) Research Collaboratory and will work with the established HCS Clinical Coordinating Center to facilitate the planning and conduct of the study.

HEAL Investigator’s Meeting: Dr. Danielle Haney provided an update on the planning of the HEAL Investigator’s meeting. The meeting will be held at the Hyatt Regency in Bethesda on 1/16-1/17.  Invited speakers include U.S. Surgeon general Jerome Adams, HHS Secretary Alex Azar, and Assistant Sec of Health Admiral Brett Giroir. Dr. Collins will lead a panel featuring Director of National Center for Injury Prevention and Control at CDC, Dr. Deb Houry; SAMHSA Director, Elinore McCance-Katz; and Director of the Center for Drug Evaluation and research at FDA, Janet Woodcock.  Dr. Koroshetz will lead a panel on understanding pain. Dr. Volkow will lead a panel on understanding OUD.  Dr. Tabak will cover data sharing and harmonization.  Breakout sessions will focus on data sharing and cross-cutting HEAL topics.  John Burklow will moderate a session featuring journalists who focus on pain and science.  There is limited space, invitations will be sent by email.


NIH & IMI-PainCare Collaboration - Laura Wandner, NINDS

The IMI-Pain Care is a public-private consortium composed of 40 participants from 14 countries. Members represent the European federation of pharmaceutical industries and associations, academic and clinical institutions, patient organizations, professional pain societies and include subject matter experts with cutting-edge technologies.
The IMI initiatives are composed of three sub-projects that each address distinct aspects and scientific pain management challenges:

  • PROMPT
    • Identifying a core set of Patient Reported Outcome Measures (PROMs) that are predictive indicators of treatment success in clinical practice and controlled trials.
    • The PROMs will address pain intensities as well as the functional consequences of pain for individuals and identifying patients at risk of experiencing chronification of acute post-operative pain.
  • BioPain
    •  Improving translatability of functional biomarkers in pain pathways
    • BioPain aims to close the translation gap by standardizing and pharmacologically validating objective measures of nociceptive signaling that translate between animals and humans.
    • 4 RCTs in healthy subjects and parallel trials in rats using electrophysiological and imaging biomarkers of peripheral, spinal and brain signaling processing
  • TRiPP
    • Improving translation in chronic pelvic pain
    • Developing of novel effective therapies has been hindered by the lack of preclinical models which reflect the full range of clinical symptoms.
    • Adopting new approaches to stratify patients by underlying mechanistic pathways, which leverage cross-disciplinary knowledge of pain mechanisms with state-of-the-art biomarker discovery, and then to developing and optimizing preclinical disease models.

Expected outcomes of the collaboration include: Aligning outcomes in acute post-operative and chronic pain (follow-up of treatment success in clinical practice, clinical trials for drug development); Refining preclinical pain models and enhancing their translation into the clinic; Providing new approaches for patient stratification in clinical trials; Identifying translatable pharmacodynamic biomarkers to prove targeted engagement in the clinical development of new analgesics; and Supporting decision making in clinical practice

In September 2019, the NIH and IMI-Pain Care representatives met at the 11th Congress of the European Pain Federation EFIC  (September 2019) to discuss opportunities to collaborate including collaboration between the Common Fund’s A2CPS program and the PROMPT initiative; collaboration on data collection and harmonizing data and models where possible; comparison of NIH and IMI’s data sharing agreements. The IMI expressed interest in learning about the HEAL initiatives.    Monthly calls were established between NIH and IMI to discuss collaboration, data sharing, preclinical model efforts, biomarker efforts and potential sub-groups to discuss data harmonization.


Centers of Excellence in Pain Education (CoEPEs) Update - Shelley Su, NIDA

The CoEPEs content has been updated and now includes 58 produced modules, 18 of which have PDF modules publicly available.  There are 6 interactive modules online. 508 compliance is expected to be complete by March 2020 with a goal of having all modules converted by September 2020.
A request for information was put out to request input for pain education curriculum, training needs, content and use of current modules. 46 responses were received from a mix of academics, contractors, patients, professional organizations, citizens, health care providers and patient advocates.

The results demonstrated that what patients are reporting as education needs does not match with professional organizations or schools’ responses.  According to the results, CoEPEs modules are not being widely disseminated outside of the organizations.

A landscape analysis was performed to: Summarize recent peer-reviewed literature assessing pain management curricula at health professional schools in the United States; Review publicly available documents to characterize the contents of pain management curricula at health professional schools in the United States; and conduct key informant interviews of curriculum leaders within health professional schools, accrediting, and licensing organizations to better understand the evolution, current state and future of pain management education within their training programs.  
The following themes were identified:

  •  Pain management preparation is inconsistent across programs, professions, specialties and disciplines.
  • Teaching is often fragmented and limited
  • Assessment narrowly focuses on pain identification
  • There is limited information regarding how trainee competencies are assessed.
  • Co-management of chronic pain and opioid use disorder is not adequately taught
  • Barriers to improved pain management preparation were consistently noted
  • Accreditation standards and oversight organizations do not adequately support critically needed improvements in pain management preparedness.
  •  In some locales, education has changed to de-emphasize opioids
  • On a positive note: some programs are adopting interprofessional and interdisciplinary approaches to address chronic pain and SUD; some innovative programs at local levels

 
2020 PC Symposium Update - DP Mohapatra, NINDS & Martha Matocha, NINR

The 2020 Pain Consortium Symposium will be held on June 3-4th at Natcher Auditorium. The theme is Technologies for Improved Understanding and Management of Pain.  The panel sessions will focus on technological advancements in the assessment and management of pain; Technologies for Understanding Pain Mechanisms Across Populations; and Innovative Technologies, Translational Developments and Devices to Treat Pain.  Dr. Matocha sent a request to PC members to recommend speakers.  

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