RFA-NS-19-036: HEAL Initiative: Early Phase Pain Investigation Clinical Network – Specialized Clinical Centers (U24 Clinical Trial Not Allowed)
Internal Deadline: Contact OOR if interested.
LOI: May 3, 2019
External Deadline: June 3, 2019
Award Information: Type: Cooperative Agreement
Estimated Number of Awards: 10
Anticipated Amount: $150,000 in direct costs for each year for 5 years
Cost Sharing: N/A
Submission Process: PIs must submit their application as a Limited Submission through the Office of Research Application Portal: https://app.wizehive.com/webform/USCgrants
Materials to submit:
- Single Page Proposal Summary (0.5” margins; single-spaced; font type: Arial, Helvetica, or Georgia typeface; font size: 11 pt). Page limit includes references and illustrations. Pages that exceed the 1-page limit will be excluded from review.
- CV – (5 pages maximum)
Who May Serve as PI: Standard NIH eligibility requirements.
The purpose of this funding opportunity announcement (FOA) is to invite applications for the Specialized Clinical Centers (“hubs”)of the Early Phase Pain Investigation Clinical Network (EPPIC-Net). EPPIC-Net will serve as the cornerstone of the NIH’s Helping to End Addiction Long-term (HEAL) Partnership. EPPIC-Net will harness multidisciplinary clinical, statistical, and data management expertise to provide the scientific leadership and infrastructure required to design and conduct multi-site Phase 2 clinical trials, biomarker validation studies, and deep phenotyping of patient populations to understand the biologic basis of a specific pain condition and its response to treatment. The overall goal is to accelerate development of non-addictive therapies for adult or pediatric patients with acute and/or chronic pain. Due to the enormous disease burden of low back pain (as outlined in the background), one further research objective of EPPIC-Net is to dissect the structures and mechanisms involved in chronic low back pain as well as to identify, prioritize and test new therapies targeted to these specific mechanisms.
Clinical studies may come to the network from two sources:
- Clinical trials to test the efficacy of therapeutic candidates (“assets”) such as small molecules, biologics, and medical devices as contributed by academic or industry partners. More details on this are outlined in the “Network Projects” and “Significant responsibilities of the CCC” sections below.
- Clinical research studies aimed at understanding the biological basis of different pain states or validation of biomarkers for their utility in phase 2 studies. These studies could result from forthcoming FOAs from NIH.
The responsibilities of the EPPIC-Net hubs include but are not limited to:
- Accepting and implementing policies and procedures approved by the EPPIC-Net Steering Committee (see EPPIC-Net Governance Committees);
- Participating in select trials conducted in EPPIC-Net;
- Identifying and recruiting spokes, including altering or adapting its spoke network to the particular needs of each clinical trial;
- Providing the spokes with clinical leadership, research support,guidance and oversight for the EPPIC-Net processes and procedures andregular communication regarding status of the EPPIC-Net and individual clinical trials;
- Providing required data for feasibility assessments of trial applications (e.g., enrollment estimates, budget estimates) to the CCC;
- Implementing trials at the hub and spoke sites, involving, but not limited to: 1) assembling local research team(s), 2) training the spokes on EPPIC-Net and trial procedures, 3) assuring protocol adherence, 4) recruiting, treating, and following patients according to the study protocols, and 5) collecting and entering accurate, high quality data and biosamples into the central data management system and repositories as run by the DCC.
- Accurately identifying and recruiting eligible subjects for clinical trials, with attention to adequate gender and minority representation;
- Retaining participants throughout the follow-up period as required by protocol;
- Ensuring adequacy of human subjects’ protections;
- Tracking and reporting trial and performance data to the CCC and/or DCC on a regular and frequent basis, including recruitment, retention, and adverse events, as required per protocol and by the IRB;
- Providing complete, accurate, and timely data entry, as well as rapid and complete resolution of any data queries, and a high level of data quality and completeness to the DCC.
- Cooperating with monitoring visits;
- Providing data to the DCC in a timely fashion for DSMB meetings;
- Actively participating in quality assessment and improvement;
- Actively participating in all EPPIC-Net Steering Committee (ENSC), and, as appropriate, SC subcommittees, EPPIC-Net Executive Committee (ENMC) or EPPIC-Net Operations Committee (ENOC) meetings and activities (see EPPIC-Net Governance Committees);
- Specifically, hub PD/PIs or designees are expected to provide scientific viewpoints and expertise on the breadth of issues discussed in the above venues, especially in the design of phase 2 trials for novel treatments in specific pain conditions.
- Participating in authorship of manuscripts and public dissemination of project results, as appropriate;
- Proposing innovative methods and leveraging existing local research resources to enhance programmatic efficiency;
- Applicants are specifically encouraged to interact with the Clinical and Translational Science Award (CTSA), if present at their institution, to identify resources. This may include access to or assistance from Recruitment (RIC) and Trial (TIC) liaisons at theCTSA.
- Promoting visibility and awareness of the EPPIC-Net within the Institution and the larger pain research community;
- Increasing and disseminating knowledge about pain research at the hub and spokes to medical students, residents, fellows, allied health professionals and nurses when feasible.Helping new investigators develop skills and experience to progress to more senior or experienced status, when appropriate.
FYI: Awards for a hub and a Clinical Coordinating Center (CCC, RFA-NS-19-023 ) or Data Coordinating Center (DCC, RFA NS-19-024) may be made to the same institution. There must be different principal investigators leading the hub and the CCC or DCC to ensure that each activity receives full attention.
Visit our Institutionally Limited Submission webpage for updates and other announcements.