Funded Projects

Project # Project Title Sort descending Research Focus Area Research Program Administering IC(s) Institution(s) Investigator(s) Location(s) Year Awarded
1U24NS115714-01
California Clinical and Translational Pain Research Consortium Clinical Research in Pain Management Early Phase Pain Investigation Clinical Network (EPPIC-Net) NINDS UNIVERSITY OF CALIFORNIA, SAN DIEGO WALLACE, MARK S San Diego, CA 2019
FOA Title: HEAL Initiative: Early Phase Pain Investigation Clinical Network - Specialized Clinical Centers (U24 Clinical Trial Not Allowed)
FOA Number: RFA-NS-19-036
Summary:

The California Clinical and Translational Pain Research Consortium (CCTPRC) consists of four University of California academic medical centers with considerable experience in pain management clinical trials, phenotyping, and biomarker validation. The network will leverage solid existing Clinical and Translational Science Award (CTSA) resources to make clinical trial execution efficient and rapid. The hub will be located at the University of California, San Diego, with spokes located on the other three campuses to provide maximum flexibility, ready to accommodate studies in a variety of pain conditions and provide successful recruitment and high-quality data collection.

1U24NS113850-01
Clinical Coordinating Center for the Health Initiative in Early Phase Pain Investigation Clinical Network Clinical Research in Pain Management Early Phase Pain Investigation Clinical Network (EPPIC-Net) NINDS MASSACHUSETTS GENERAL HOSPITAL FAVA, MAURIZIO; DWORKIN, ROBERT H; EDWARDS, ROBERT R; RATHMELL, JAMES P Boston, MA 2019
FOA Title: HEAL Initiative: Early Phase Pain Investigation Clinical Network - Clinical Coordinating Center (U24 Clinical Trials Not Allowed)
FOA Number: RFA-NS-19-023
Summary:

The objective of the Early Phase Pain Investigation Clinical Network (EPPIC-Net) and EPPIC- Net initiatives is to rapidly and efficiently translate advances in the neurobiology of pain into treatments for people with chronic and acute pain, conditions associated with a significant burden to both patients and society. The Clinical Coordinating Center (CCC) for EPPIC-Net will promote and facilitate, from initial conception through final analysis, clinical trials in adult and pediatric populations with acute or chronic pain by providing efficient methodological, organizational, and logistical support. The EPPIC-Net-CCC will adopt and establish processes aimed at dramatically increasing the efficiency of multicenter clinical trials, improving the overall quality of clinical trials, promoting patient recruitment and retention as well as increasing the number of clinical investigators and research staff well trained and passionate about leading and conducting multicenter clinical trials.

1U24NS114416-01
Duke Pain Early-phase Research Clinical Center (PERC) Clinical Research in Pain Management Early Phase Pain Investigation Clinical Network (EPPIC-Net) NINDS DUKE UNIVERSITY LIMKAKENG, ALEXANDER TAN; KEEFE, FRANCIS J Durham, NC 2019
FOA Title: HEAL Initiative: Early Phase Pain Investigation Clinical Network - Specialized Clinical Centers (U24 Clinical Trials Not Allowed)
FOA Number: RFA-NS-19-025
Summary:

Managing persistent pain has long been a difficult challenge, one that is heightened by the recent opioid crisis. Although many potential solutions may exist, demonstrating their efficacy in a multicenter trial is a considerable obstacle. There is broad consensus that a nationwide clinical research network is necessary to promote innovation. A hub-spoke complex of academic medical centers with considerable experience in pain management clinical trials and biomarker validation will leverage existing resources to make clinical trial execution efficient and rapid. Together, spokes will provide maximum flexibility, ready to accommodate studies in any well-characterized pain condition.

1U24NS113847-01
Early Phase Pain Investigation Clinical Network: Greater New York Clinical Center Clinical Research in Pain Management Early Phase Pain Investigation Clinical Network (EPPIC-Net) NINDS NEW YORK UNIVERSITY SCHOOL OF MEDICINE DOAN, LISA; LIPTON, RICHARD B New York, NY 2019
FOA Title: HEAL Initiative: Early Phase Pain Investigation Clinical Network - Specialized Clinical Centers (U24 Clinical Trials Not Allowed)
FOA Number: RFA-NS-19-025
Summary:

The Greater New York Clinical Center (GNYCC) aims to engage experts in pain research and pain practice to build the infrastructure required to support the objectives of the Early Phase Pain Investigation Clinical Network (EPPIC-Net). The GNYCC will provide expertise and resources to perform phase 2 clinical trials to test the efficacy of novel pain treatments, as well as phenotyping and biomarker studies that will enable customized treatments. The consortium comprises four major academic centers in New York City, one of the most diverse cities in the United States and the nation’s largest metropolitan area. We will 1) build infrastructure to rapidly access clinical trial resources and a network of investigators and clinical leaders, 2) develop a plan for swift evaluation and launch of proposed studies, and 3) optimize patient retention and monitor sites to ensure protocol adherence, data quality, and efficiency.

1U24NS113844-01
EPPIC-NET DCC Clinical Research in Pain Management Early Phase Pain Investigation Clinical Network (EPPIC-Net) NINDS NEW YORK UNIVERSITY SCHOOL OF MEDICINE PETKOVA, EVA; TROXEL, ANDREA B New York, NY 2019
FOA Title: HEAL Initiative: Early Phase Pain Investigation Clinical Network - Data Coordinating Center (U24 Clinical Trials Not Allowed)
FOA Number: RFA-NS-19-024
Summary:

The Data Coordinating Center (DCC) of the Early Phase Pain Investigation Clinical Network (EPPIC-Net) will be the data and biospecimen manager for pain research within the HEAL Partnership. As such, it will host, manage, standardize, curate, and provide a sharing platform for data and biospecimens for HEAL initiatives, such as the Acute to Chronic Pain Signatures initiative and the BACPAC, in addition to EPPIC-Net studies. The DCC will develop and maintain a databank for depositing data, will link these data with a repository for biological samples, and will create a platform for teams to work together to analyze and interpret data. Further, the DCC will provide leadership in the statistical design and analysis of EPPIC-Net studies and will deploy advanced systems and processes for data collection, management, quality assurance, and reporting. The DCC will create, sustain, and continually advance a robust organization for the rapid design, implementation, and performance of high-quality rigorous Phase II clinical trials to test promising therapeutics for pain.

1U24NS115678-01
EPPIC-Net Hub at University of Washington Clinical Research in Pain Management Early Phase Pain Investigation Clinical Network (EPPIC-Net) NINDS University of Washington BACKONJA, MIROSLAV MISHA; CURATOLO, MICHELE ; STACEY, BRETT Seattle, WA 2019
FOA Title: HEAL Initiative: Early Phase Pain Investigation Clinical Network - Specialized Clinical Centers (U24 Clinical Trial Not Allowed)
FOA Number: RFA-NS-19-036
Summary:

The Helping to End Addiction Long-term? (HEAL) Initiative’s Early Phase Pain Investigation Clinical Network (EPPIC-Net) is a unique opportunity to impact the management of pain, through expeditious discovery and validation of biomarkers and analgesic therapies, and in-depth phenotyping. The University of Washington’s (UW) Division of Pain Medicine (UW Pain; “hub”) includes four core clinical sites. Committed spokes include specialty care clinics, primary care clinics, external academic medical centers, and health systems. To achieve the goals of the HEAL Initiative’s EPPIC-Net, the study group will (1) establish UW EPPIC-Net hub and spokes infrastructure, provide scientific leadership and administrative oversight, and apply expertise in design and conduct of high-quality multidisciplinary Phase 2 clinical trials and biomarker validation studies; (2) develop policies and procedures for rapid design, initiation, recruitment, conduct, and closure of high-quality multidisciplinary Phase 2 clinical trials and biomarker validation studies for specific pain conditions at UW Pain EPPIC-Net hub and spokes; and (3) establish mechanisms for communication, education and training, and performance assessment of the UW-EPPIC-Net hub and spokes, to assure efficient and timely utilization of resources to most effectively recruit research participants into EPPIC-Net.

1U24NS115679-01
MACC/EPICC-Net as a Hub for the HEAL Initiative EPICC-Net Clinical Research in Pain Management Early Phase Pain Investigation Clinical Network (EPPIC-Net) NINDS MEDICAL COLLEGE OF WISCONSIN HERNANDEZ-MEIER, JENNIFER LYNN Madison, WI 2019
FOA Title: HEAL Initiative: Early Phase Pain Investigation Clinical Network - Specialized Clinical Centers (U24 Clinical Trial Not Allowed)
FOA Number: RFA-NS-19-036
1U24NS113846-01
Medical University of South Carolina Specialized Clinical Center of EPPIC-Net Clinical Research in Pain Management Early Phase Pain Investigation Clinical Network (EPPIC-Net) NINDS MEDICAL UNIVERSITY OF SOUTH CAROLINA BORCKARDT, JEFFREY J; BRADY, KATHLEEN T Charleston, SC 2019
FOA Title: HEAL Initiative: Early Phase Pain Investigation Clinical Network - Specialized Clinical Centers (U24 Clinical Trials Not Allowed)
FOA Number: RFA-NS-19-025
Summary:

The Medical University of South Carolina (MUSC) Specialized Clinical Center (Hub) of the Early Phase Pain Investigation Clinical Network (EPPIC-Net) will provide a robust and readily accessible infrastructure for rapid implementation and performance of high-quality comprehensive studies of novel treatments for patients with a wide variety of pain conditions. The MUSC-Hub will harness multidisciplinary clinical, research, statistical, and data management expertise to provide the scientific leadership and infrastructure required to design and conduct multisite Phase II clinical trials, biomarker validation studies, and deep phenotyping of patient populations as part of the EPPIC-Net with the overall goal of accelerating the development of new therapies for patients with acute and/or chronic pain.

1U24NS115689-01
Specialized Clinical Center at MGH for the Early Phase Pain Investigation Clinical Network Clinical Research in Pain Management Early Phase Pain Investigation Clinical Network (EPPIC-Net) NINDS MASSACHUSETTS GENERAL HOSPITAL MAO, JIANREN Boston, MA 2019
FOA Title: HEAL Initiative: Early Phase Pain Investigation Clinical Network - Specialized Clinical Centers (U24 Clinical Trial Not Allowed)
FOA Number: NS115689-01
Summary:

The MGH EPPIC-Net hub will utilize two well-established collaborative entities in both patient care and clinical research at the Massachusetts General Hospital (MGH): 1) MGH Division of Pain Medicine and 2) MGH Center for Translational Pain Research. This hub-spoke network at MGH will include four core spokes consisting of both academic centers and community health care organizations, as well as over a dozen spokes that can be recruited as needed based on special requirements of phase II trials and research studies. The responsibilities of this hub-spoke network at MGH include a) coordinating phase II trials/clinical biomarker validation studies; b) recruiting well-phenotyped subjects in a timely manner; c) collecting clinical data and targeted outcome data tailored to meet the needs of each clinical trial/study; and d) maintaining communications within and outside the hub, including the NIH EPPIC-Net.

1U24NS113849-01
The Icahn School of Medicine at Mount Sinai (ISMMS) EPPIC-Net Specialized Clinical Center Clinical Research in Pain Management Early Phase Pain Investigation Clinical Network (EPPIC-Net) NINDS ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI ROBINSON-PAPP, JESSICA New York, NY 2019
FOA Title: HEAL Initiative: Early Phase Pain Investigation Clinical Network - Specialized Clinical Centers (U24 Clinical Trials Not Allowed)
FOA Number: RFA-NS-19-025
Summary:

The Icahn School of Medicine at Mount Sinai (ISMMS) will support the mission of the Early Phase Pain Investigation Clinical Network (EPPIC-Net), through the ISMMS Department of Neurology as the core of a hub and spokes structure. The study contains four specific aims: (1) to streamline and optimize rapid implementation of EPPIC-Net studies, exceeding the required minimum of 100 subjects recruited per year to EPPIC-Net studies; (2) to ensure access to patient populations with a wide range of pain disorders, including CLBP, using a hub and spokes model to ensure effective recruitment; (3) to provide the highest-quality protocol implementation, deep clinical phenotyping of pain disorders, and accurate and complete data collection; and (4) to work collaboratively with the EPPIC-Net Coordinating Centers and investigators from the NIH HEAL Partnership to assist with development/design of clinical trials. The study team will also increase training opportunities through EPPIC-Net within ISMMS and the larger pain research community, training junior investigators to become future pain clinical trials leaders and increase and disseminate knowledge about pain research throughout the network.

3U24NS113849-01S1
The Icahn School of Medicine at Mount Sinai (ISMMS) EPPIC-Net Specialized Clinical Center Clinical Research in Pain Management Early Phase Pain Investigation Clinical Network (EPPIC-Net) NINDS ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI ROBINSON-PAPP, JESSICA New York, NY 2020
FOA Title: Notice of Special Interest to Encourage Eligible NIH HEAL Initiative Awardees to Apply for Administrative Supplements to Promote Training in Clinical Research on Pain (Admin Supp ? Clinical Trial Not Allowed)
FOA Number: NOT-NS-20-044
Summary:

Exacerbation of health disparities has emerged during the COVID 19 pandemic and highlighted the recognition that minority underrepresentation in clinical research may contribute to racial disparities in health outcomes. In clinical trials related to pain, disparities in trial patient inclusion are documented by white patients often being overrepresented. Mitigating these disparities is an area in which an early-career pain investigator training and contributions may have lasting benefits. The pandemic also drove rapid expansion of telehealth for pain management without knowledge of how social and demographic factors affect utilization patterns of this care delivery model. This supplement supports research to examine the extent to which disparities exist in access to and outcomes of telehealth in socially marginalized pain patients. Findings will be applied to enrich the diversity in clinical trial populations for phase 2 safety trials performed in the HEAL EPPIC Network.

1U24NS113800-01
University of Florida Early Phase Pain Investigation Clinical Center Clinical Research in Pain Management Early Phase Pain Investigation Clinical Network (EPPIC-Net) NINDS UNIVERSITY OF FLORIDA PRZKORA, RENE; TIGHE, PATRICK J Gainesville, FL 2019
FOA Title: HEAL Initiative: Early Phase Pain Investigation Clinical Network - Specialized Clinical Centers (U24 Clinical Trials Not Allowed)
FOA Number: RFA-NS-19-025
Summary:

A major barrier to developing new pain treatments has been the absence of infrastructure to facilitate well-designed and carefully conducted clinical trials to test the efficacy of promising treatments. The UF Health Specialized Clinical Center Network will include UF Health as “hub” and statewide partners serving as spokes as part of the EPPIC Network. The University of Florida (UF) has the capability to reach more than 50% of the population of Florida, the third most populous state of the United States, and the capacity to successfully enroll patients with varying pain conditions into clinical trial protocols through its hub and spoke infrastructure as part of EPPIC-Net.

1U24NS115708-01
University of Pittsburgh Hub and Spoke Pain Clinical Trial Network Clinical Research in Pain Management Early Phase Pain Investigation Clinical Network (EPPIC-Net) NINDS UNIVERSITY OF PITTSBURGH AT PITTSBURGH WASAN, AJAY D Pittsburgh, PA 2019
FOA Title: HEAL Initiative: Early Phase Pain Investigation Clinical Network - Specialized Clinical Centers (U24 Clinical Trial Not Allowed)
FOA Number: RFA-NS-19-036
Summary:

For many years in the field of pain medicine it has been noted that many promising treatments emerging from animal studies fail to demonstrate efficacy in human trials. There are many reasons for these phenomena, and one of the key steps to improve this situation and establish more effective nonopioid treatments for pain is more rigorous conduct of multisite pain clinical trials from an experienced multidisciplinary team of investigators. The University of Pittsburgh Hub and Spoke Clinical Trials Network will establish an organizational structure to capitalize on institutional expertise at our Spokes to lead specific phase 2 clinical trials through EPPIC-Net.

1U24NS113784-01
University of Rochester Hub and Spokes for the EPPIC Network - Specialized Clinical Center Clinical Research in Pain Management Early Phase Pain Investigation Clinical Network (EPPIC-Net) NINDS UNIVERSITY OF ROCHESTER MARKMAN, JOHN DOUGLAS; GEWANDTER, JENNIFER Rochester, NY 2019
FOA Title: HEAL Initiative: Early Phase Pain Investigation Clinical Network - Specialized Clinical Centers (U24 Clinical Trials Not Allowed)
FOA Number: RFA-NS-19-025
Summary:

The NIH’s HEAL Initiative aims to support collaboration between clinical research experts in academia and industry to accelerate the development of highly efficacious, nonaddictive analgesics for well-defined chronic pain syndromes. The University of Rochester (UR), and its leadership for the UR Hub and Spokes within Early Phase Pain Investigation Clinical Network (EPPIC-Net), will recruit subjects with a broad range of pain conditions, with a focus on leveraging clinical trial infrastructure to support patient recruitment and retention, timely and accurate data entry, and regulatory documentation, as well as recruit additional Spoke sites through a national network of analgesic researchers.

1U24NS115691-01
UPENN HEAL - Pain Clinical Trial Network Specialized Clinical Center Clinical Research in Pain Management Early Phase Pain Investigation Clinical Network (EPPIC-Net) NINDS UNIVERSITY OF PENNSYLVANIA FARRAR, JOHN T; ASHBURN, MICHAEL ALAN Philadelphia, PA 2019
FOA Title: HEAL Initiative: Early Phase Pain Investigation Clinical Network - Specialized Clinical Centers (U24 Clinical Trial Not Allowed)
FOA Number: RFA-NS-19-036
Summary:

EPPIC-Net will provide a robust and readily accessible infrastructure for the rapid implementation and performance of high-quality comprehensive studies of patients with well-defined pain conditions, and the rapid design and performance of high-quality Phase 2 clinical trials to test promising novel therapeutics for pain. Using the Hospital of the University of Pennsylvania as a hub and five additional centers that are part of the UPenn Health System and the Children’s Hospital of Philadelphia (CHOP) as spokes, studies will be conducted as designed by the expertise of the EPPIC Network, which intends to bring intense focus to relatively small numbers of patients with clinically well-defined pain conditions and high unmet therapeutic needs. The UPenn Specialized Clinical Center (SCC) will test novel, efficient study designs including adaptive and platform designs, validation studies of biomarkers, and biomarker-informed proof of principle or target engagement studies in Phase 2 trials of interventions from academic and industry partners.