A Call to Action: A unique opportunity to advance the effective management of pain while minimizing risk of addiction

A Call to Action: A unique opportunity to advance the effective management of pain while minimizing risk of addiction

In June 2018, NIH rolled out the Research Plan for the NIH HEAL (Helping to End Addiction Long-termSM) Initiative, a trans-agency effort to speed scientific solutions to the opioid crisis. We are now excited to announce the publication of over 30 Funding Opportunity Announcements (FOAs) for fiscal year 2019, 20 of which are focused on developing non addictive pain treatments, or comparative effectiveness studies of available modalities including non-pharmacologic treatments.  There is an urgent need to provide effective, non-addictive treatments for pain to reduce our reliance on opioids and improve patient quality of life.  The HEAL Initiative is a very special opportunity to advance pain science. However, success now depends on a robust response from the scientific community to join the research effort. The funding opportunity announcements will catalyze a broad, multi-disciplinary response from a research community eager to take advantage of emerging scientific opportunities to address this rising public health need.

Because this crisis is so broad and multi-faceted it requires the collective effort of many NIH Institutes and Centers, each of which have a compelling interest in addressing the issue of opioid addiction and overdose and chronic pain in this country. Since 2003, as many as twenty-three NIH Institutes and Centers have worked together through the NIH Pain Consortium to enhance pain research and promote collaboration among pain researchers – and many of these are directly involved in these new HEAL programs. NINDS leads the NIH Pain Consortium and is engaged in a number of new programs that are outlined below, in addition to the ones that I described in June.

Testing of novel assets in an early phase pain clinical trial network

As I discussed in my June Director’s Message, the cornerstone of the NIH HEAL Initiative’s efforts to develop effective, non-addictive pain treatments will be a clinical trials network to accelerate new drug and device testing in early clinical trials for safety and efficacy (Phase 2 trials). This Early Phase Pain Investigation Clinical Network (EPPIC-net, formerly named the Clinical Trials Network on Pain Research), will establish the clinical infrastructure to focus on these phase 2 trials in deeply phenotyped cohorts with specific pain conditions.  It will work to validate specific biomarkers of target engagement or proof of principle in a multi-site setting and accommodate novel trial designs. The clinical trials themselves will test small molecules, biologics, and devices (ie., assets) that come from industry and academia. NIH will work with the Foundation for NIH (FNIH)and partners in industry and academia to solicit the submission of promising assets to NIH peer review and those judged highly meritorious will be tested in phase 2 clinical trials in EPPIC-net. Through its standing infrastructure, EPPIC-net will continually iterate to reduce study start-up times, and de-risk the challenges of Phase II clinical pain trials to accelerate the approval of effective, non-addictive therapies for treating pain. The EPPIC-Net Data Center will serve as a resource for data and biosamples coming from other HEAL projects as well as industry studies.

Translating discoveries into effective devices for pain treatment

NINDS plays an important role in both the NIH Stimulating Peripheral Activity to Relieve Conditions (SPARC) and Brain Research through Advancing Innovative Neurotechnologies® (BRAIN) Initiatives. In order to build on the research gains catalyzed by these initiatives towards the development non-addictive treatment options for pain, we are offering research opportunities to leverage these insights and technological advances   to develop devices that directly modulate pain circuits at the peripheral nerve, spinal cord or brain level. By supporting target identification, late-stage translational therapeutic and diagnostic device development, verification and validation activities, and early clinical studies, NIH will advance device-based treatments for people without effective ways to manage their pain.

Cross-cutting pain programs

Since pain is a cross-cutting issue at NIH, NINDS also is serving as a partner to several programs being led by other Institutes and Centers. The Back pain consortium (BACPAC), led by the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS),  will work in conjunction with EPPIC-net to conduct studies to better understand mechanisms of chronic low back pain, improve patient phenotyping, develop improved diagnostic and treatment tools, identify, prioritize, and test mechanistically based therapies. The Pain Management Effectiveness Research (Pain Management-ERN) will leverage the Trial Innovation Network (TIN) established by the National Center for Advancing Translational Sciences (NCATS) to conduct clinical trials designed to evaluate the effectiveness of pharmacologic and nonpharmacologic therapies for a broad array of acute and chronic pain conditions through phase 3 clinical trials. Our colleagues at the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) are leading an integrated approach to pain management and opioid reduction in hemodialysis patients, a population that are typically prescribed high amounts of opioids for pain. Lastly, with the National Center for Complementary and Integrative Health (NCCIH), NIH is supporting clinical research to integrate evidence-based interventions for pain into health care systems. Studies will be embedded in real world settings to determine the effectiveness of multiple interventions across pain conditions including non-pharmacologic treatments.

This release of a broad suite of funding opportunities focused on addressing the multi-pronged challenges of opioid addiction, acute pain, and numerous chronic pain conditions is a call to action for the entire biomedical research community.  The size and scope of this extraordinary trans-NIH initiative is dwarfed only by the urgency of the opioid crisis itself – if your research interests and expertise can possibly align with the opportunities released through HEAL, I urge you to consider applying.  We need the best, most creative scientists to join this effort!  

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Wednesday, December 19, 2018