Pain Opioid Actively Managed Portfolio (POp.AMP): Research Advisory Committee Overview
"The Pain Opioid Actively Managed Portfolio (POp.AMP) focuses on addressing pain, opioid addiction, and suicide prevention through proactive management, agile funding mechanisms, and collaboration with various stakeholders. The committee utilizes a rotational leadership model to ensure efficient research efforts and avoid overlapping with clinical partners. Key milestones include drafting charters, finalizing project lists, setting priorities, and releasing funding opportunities. The portfolio's purview includes clinical studies on pain genetics, non-opioid treatments, and treatment implementation. The committee aims to align with clinical partners and other AMPs while seeking input from key stakeholders for refinement and approval."
Download Presentation
Please find below an Image/Link to download the presentation.
The content on the website is provided AS IS for your information and personal use only. It may not be sold, licensed, or shared on other websites without obtaining consent from the author. Download presentation by click this link. If you encounter any issues during the download, it is possible that the publisher has removed the file from their server.
E N D
Presentation Transcript
Office of Research and Development Pain Opioid Actively Managed Portfolio (POp AMP) Suicide Prevention Research Advisory Committee April 25, 2023
POP AMP FEATURES Pain Opioid AMP Rotational leadership model Proactively interact with relevant VA clinical/operations and NIH/DoD/other funder contacts Ensure that ORD is not funding the same work as clinical/operations partners Proactive management of the portfolio community, including bringing together researchers and/or other stakeholders to accomplish goals The ability to stand up agile funding mechanisms when required 2
Team-led AMP model Rotational Leadership Current SPMs of pain/opioid panels Members from each service: Audrey Kusiak RRD Carol Fowler BLRD Cathie Plouzek HSRD Jayanthi Sankar CSRD
12/16/22: Charged by CRADO 12/19 - 1/23/23: Draft Charters Unit, Role and Executive committee 1/16-1/31/23: Draft Purview and project list 1/23-1/31/23: Finalize charters 1/26 April 23: funding model SOP (final) 1/31/23: AMP stood up Feedback from services/leadership sought at each step
2/23/23: Presentation to ISRM LC (Purview final) 3/31/23: Portfolio analysis 3/31/23: Budget Analysis 4/1/23: Priority/Vision Setting (focus grps/Exec committee) 4/18/23: Release Broad RFA (purview based) Summer 2023: First submission/peer review Fall 2023 (tentative): Release focused RFA(s)
Starting Point: Purview of current review panels/portfolio in AMP s area Alignment with clinical partners Identify/resolve overlap with other AMPs and portfolios Aim for broad definitions Solicit input from AMPs/Services & SPMs Submit refined draft to ISRM LC for approval
POP AMP PURVIEW - EXAMPLE 1. Clinical studies of the genetic, anatomical, and behavioral basis of algesia (pain), or tolerance, addiction, opioid metabolism, and tapering of opioid medication in acute and chronic painful conditions. 2. Clinical treatments emphasizing non-opioid medications and complementary and integrative approaches. 3. Implementation of treatments and approaches across VAMCs, evaluation of methods to enhance pain services, and evaluation of the quality and safety of pain care. 4. Preclinical development and translation of non-opioid therapies; and the accompanying anatomical, molecular, biochemical, behavioral, and genetic mechanism(s). 7
POP AMP PURVIEW - EXAMPLE 5. Studies identifying therapeutic targets for algesia (pain), tolerance and/or addiction to opioid medication in acute and chronic painful conditions. 6. Interventional and observational research of interventions to improve outcomes in opioid use disorder, including new models for OUD care, medication and behavioral therapy for OUD, use of overdose rescue medication. 7. Examination of pharmacology, pharmacotherapeutics, pharmacogenomics, and phenotype as well as the use of functional outcomes (e.g., correlating subjective pain measures with objective measures of function such as ADL, gait kinetics and kinematics, range of motion, and QoL or activity measures, etc.). 8
1. Establish Budget baseline based on purview. Identify currently funded Pain/Opioid projects Ensure projects in RAFT are coded appropriately Broad Sweep/Data pull in RAFT (RPA or DRA) Refine project list based upon purview Review aims/entire research plans a. Determine focus/primary/endpoint b. Include overlaps c. Create a spreadsheet of AMP and non-AMP projects Solicit feedback from AMPs/Services & SPMs and resolve overlaps Submit final list to ISRM LC for approval
2. Establish AMP budget Break out portfolio by: Service (include CSP if relevant) Projects on Hold Projects that are rolling off funding by FY Projects that are coded in the AMP but falls under another portfolio/AMP (not AMP) Total each category Provide analysis to Finance (base) Provide a projected need for additional funds (must be approved by ISRM council)
Operational Details for POP AMP: 1. POp AMP will have a budget of $28.9 million for FY23. This includes: a) $27.3 million for projects that are currently located in the Pain and Opioid Research Project Areas (RPA) in RAFT, as identified by Audrey Kusiak. Eleven (11) projects totaling $1.6 million are on hold awaiting JIT. b) The FY23 budget request includes twenty-one (21) projects that will be ending in 2023, totaling appx. $3.1 million. c) POp AMP is requesting an additional $10 million* in funds for: Targeted RFA areas. Possible rapid-response to congressional support of the use of marijuana for pain. * Pending approval from the ISRM Leadership Council
The allocation total below reflect only allocated funding, and not projects on hold. The # of Projects reflect funding allocated and projects on hold (a total of 31 projects are on hold). Service Allocation Total # of Projects Current Budget Analyst/ AO BLR&D (821) $5,105,126 27 Sara Clark CSR&D (829) $5,060,765 14 Lisa Eiben CSP (825) $4,333767 1 Tanya Byfield/Bill Lance HSR&D (824) $6,735,283 26 Diane Murphy RR&D (822) $7,674,399 47 Deborah Allen/Tiffany Asqueri Totals: $28,909,340 115
3. PRIORITY / VISION-SETTING - EXAMPLE Establish Executive Committee - Exec Committee will coordinate with the AMP to prioritize focus areas of study. VHA clinical staff SMEs consider all services/departments VA Researchers not in subject area to avoid conflict Other Federal Stakeholders (NIH or DoD) Must be approved by ISRM Council 13
3. PRIORITY / VISION SETTING (CONTD) Identifying clinical area(s) in need of research- based evidence POp-AMP used QUERI to conduct a survey of stakeholders from VISN Directors, Chiefs of Staff, clinicians, pharmacists, administrators, and Veterans focus groups to identify areas based on purview. Other AMPs created focus groups and held F2F meetings to identify key areas Once areas have been identified, they are presented to the Executive Committee for prioritization. 14
1. Draft metrics and measurements of success for AMP 2. Broad RFA (based upon purview) Must be approved by ISRM LC and Released 3. Portfolio Analysis (Rios and AMP) 4. Craft Focused RFAs based on priority areas determined by Executive Committee Must be approved by ISRM LC and released
4. POP AMP BROAD RFAS - EXAMPLE Decide if Companion Pre-Application (I02) is needed Parent RFA Pre-clinical, observational and epidemiological studies Clinical Trial RFA Single and Multi-site Clinical Trials 16
4. PARENT MERIT REVIEW AWARD - EXAMPLE Decide funding stream/budget caps. PoP AMP adopted the following scheme (common to RRD, HSRD and CSRD): No annual budget cap; thus, variable funding may be utilized as long as the overall budget cap (based on years requested) is maintained. The salary for all personnel, including the contact PD/PI is included in this cap. 1 year = $300,000 max 2 years = $600,000 max 3 years = $900,000 max 4 years = $1,200,000 max 17
4. CLINICAL TRIAL RFA - EXAMPLE Clinical Trial Award Budget Cap and Duration Budget Item Limit for Single Site Limit for Multi-VAMC Sites For a 2-site a total: For two (2) years, $600,000 For three (3) years, $1,125,000 For four (4) or five (5) years, $1,500,000 Additional $100,000 per site per year for each additional site. For two (2) years, $600,000 For three (3) years, $900,000 For four (4) years, $1,200,000 Budget Cap Duration Up to four (4) years Up to five (5) years 18
5. NOTABLE SECTIONS IN POP/AMP RFAS Example: Engagement of Veterans in the Design and Implementation of Research If recruiting human subjects: Veterans and their caregivers can provide important insights into what outcomes matter most and the feasibility and acceptance of proposed interventions and study designs. Options for obtaining input include interaction with Veteran engagement panels or Veteran advisory groups as well as including Veterans on the research team. Example of Pain/Opioid CORE s Veterans Engagement Panel 19
5. NOTABLE SECTIONS IN RFAS - EXAMPLE Implementation and Dissemination Plan - For Health Services Studies Dissemination in manuscripts and to partners is insufficient. Explicitly discuss next steps after project is completed. What is the path to making a difference in VA care? Need to consider who owns the problem the study is attempting to solve potential barriers to implementation, and how to overcome Who will be the partner to implement the project? Studies of interventions should consider how they can collect information relevant to implementation during the efficacy/effectiveness study (e.g., use of hybrid designs). 20
CALENDAR EXAMPLE - MAINTAINS 4 CYCLES Cycle I (Winter HSR&D & RR&D) Cycle II (Spring BLR&D and CSR&D) January 1 & November 1 for Clinical Trials Cycle III (Summer HSR&D & RR&D) Cycle IV (Fall BLR&D and CSR&D) Submission Cycles Pre-application (I02) Letter of Intent & Waiver Request Submission Deadline Begin Submitting Applications to RFA Down-to-the-Wire Application Submission Deadline Application Submission Deadline to Grants.gov. Verification Deadline in eRA July 1 & May 1 for clinical trials November 1 May 1 November 15 February 1 May 15 August 1 5 business days prior to the Verification Deadline 3 business days prior to the Verification Deadline 5:00 p.m. local time December 15 March 10 Cycle I (Winter HSR&D & RR&D) CSR&D) February May - June March April July AugustAugust June 15 Cycle III (Summer HSR&D & RR&D) August September 11 Cycle II (Spring BLR&D & Cycle III (Fall BLR&D & CSR&D) November - December January - February Review and Award Cycles Scientific Merit Review Administrative Review September 21
CONTACTS FOR POP AMP RR&D Audrey Kusiak Audrey.Kusiak@va.gov BLR&D Carol Fowler Carol.Fowler@va.gov HSR&D Cathie Plouzek Cathie.Plouzek@va.gov CSR&D Jayanthi Sankar Jayanthi.Sankar@va.gov 22
QUESTIONS ? 23
