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VA Research and Development Program

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  • 1. VA Research and Development Program Joel Kupersmith, MD Chief Research & Development Officer
  • 2. Rich 85 Year History
    • Mission: “To discover knowledge and create innovations that advance the health and care of Veterans and the nation.”
    • 3 Nobel Laureates, 6 Lasker Award Winners
    • Many important discoveries and inventions
      • Cardiac Pacemaker
      • First liver transplant
      • Radioimmunoassay
      • CT Scanner
      • First large scale clinical trial – TB
      • 1 st multisite RCT of antihypertensive Rx
      • Lithium and Biologic Psychiatry
  • 3. Secretary's 13 Transformational Initiatives
    • Eliminate Veteran homelessness
    • Enable 21st century benefits delivery and services (e.g., backlog)
    • Automate GI Bill benefits
    • Implement virtual lifetime electronic records (VLER)
    • Improve Veteran mental health
    • Build Veteran relationship management (VRM) capability to enable convenient, seamless interactions
    • Design a Veteran-centric healthcare model and right-sized infrastructure to help Veterans navigate the healthcare delivery system and receive coordinated care
    • Expand healthcare access for Veterans, including women and rural populations
    • Ensure preparedness to meet emergent national needs (e.g., hurricanes, H1N1 Virus)
    • Develop capabilities and enabling systems to drive performance and outcomes
    • Establish strong VA management infrastructure and integrated operating model
    • Transform human capital management
    • Perform Research and Development to enhance the long-term health and well-being of Veterans
  • 4. Presidential Directive on Peer Review
    • “ When scientific or technological information is considered in policy decisions, the information should be subject to well-established scientific processes, including peer review where appropriate, and each agency should appropriately and accurately reflect that information in complying with and applying relevant statutory standards”
    • Barack Obama, March 9, 2009
  • 5. White House OSTP* Themes and Initiatives *Office of Science and Technology Policy
    • A Healthy America
      • Translational research to turn discovery into better practice (from bench to bedside)
      • Boosting clinical research
      • Improving care for the wounded warrior
      • Achieving a promise of personalized medicine
      • Assisting in the broader priority of improving health care access
  • 6. OIG Report on VA Research
    • OIG Report on VA research, February 27, 2009
      • Initiated by MilCon, VA Subcommittee of House of Rep. Appropriations Committee
    • Conclusions of OIG Report
      • Appropriated funds for VA research address the broad spectrum of medical issues with which Veterans contend
      • VHA’s reporting of how research funds are utilized could be more detailed and transparent
  • 7. General Characteristics of VA Research
  • 8. Intramural Research Program
    • VA Research connected directly to nation ’ s largest health system (being “ Intramural ” )
      • >70% of investigators are clinicians
      • Links researchers directly Veterans ’ needs
      • Facilitates implementation of research results
    • Broad, extensive research portfolio that balances the needs of all Veterans
      • ≈ 2100 ORD funded projects
  • 9. Intramural Research Program
    • 116 VAMCs have capacity for research (FWA)
      • ≈ 100 are funded by ORD at any time
    • Community of ≈3000 VA researchers with a long history of significant research
      • Published 65,158 articles in past 9 years
      • Publish in the best journals
  • 10. Research Services
    • Basic Laboratory R & D
    • Clinical Science R & D
      • Cooperative Studies Program – Large clinical trials
    • Rehabilitation R & D
    • Health Services R & D
      • Quality Enhancement Research Initiative (QUERI) –Implementation research in which VA is the pioneer
  • 11. VA Research Points to Remember
    • Office of Research and Development does not oversee all VA research
      • RECC’s, etc
      • Epidemiology section
      • Program offices
    • Many interests in VA research
      • Considerable input on what research to do
  • 12. Budgets
  • 13. Research funding (million $) 0 200 400 600 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 VA 0 10,000 20,000 30,000 40,000 NIH
  • 14. Research funding (% increase per year) VA NIH 0% 4% 8% 12% 16% 2002 2003 2004 2005 2006 2007 2008 2009 2010
  • 15. VA Budget
    • 4 components
      • Congressional appropriation
      • VERA $s
      • NIH
      • Other – Mainly industry
    • NIH and CDMRP awards
      • NIH funding VA competitively awarded to investigators exceeds the VA research appropriation
      • 44% of TBI/PTSD Congressionally Directed Medical Research Program $s awarded to VA investigators
  • 16. Creating a Culture of Research Compliance in VAMCs
  • 17.  
  • 18. Principles for Medical Centers
    • VA commits that in the conduct of research VA will
      • Ensure that members of the research team will conduct themselves as professionals conducting themselves in the highest standards of quality and ethics in their work
      • Undertake research only if it is reviewed, approved and monitored by the appropriate VA committees that ensure that the research trial is properly designed, does not involve undue risks and includes safeguards for participants
      • Clearly explain that research is voluntary , only occurs with written consent and that patient’s have a right to change her mind at any time without affecting their VA healthcare or benefits
      • Educate individuals were considering enrolling in the research study about the study and its possible benefits and risks
      • Safeguard each participant’s information
  • 19. Stakeholders in VA Research
    • Stakeholders include
      • Veterans
      • Veteran Service Organizations
      • Other Veterans advocacy groups (e.g. related to Gulf War)
      • Academic Medical Centers
      • Medical specialty societies
      • Congressional Committees
      • Department of Veterans Affairs
        • E.g., Other program offices, VISNs, VAMCs
      • White House
    • Each stakeholder has different agendas as to what type of research VA should do
    • Need to maintain balance in the research program
  • 20. Stakeholder Support for ORD
    • Recent increases in research appropriation
    • VSO support
      • E.g. Support of Research Week and others
    • Friends of VA
      • Group includes Association of American Medicinal Colleges, medical specialty societies, VSO’s, research organizations
    • Veterans’ survey (below)
  • 21. Challenges
  • 22.
    • Others mandate research that is not part of ORD investment strategy
    • Maintenance of a research portfolio that reflects Veterans’ needs as well as consideration of strong stakeholder interests
    • Bureaucratic obligations
    • Physical infrastructure - addressed in budget submission
    • Compliance
    Challenges
  • 23.
    • Maintenance of human capital resources - issues related to protected time and bureaucracy
    • Continuance of internal integration/communication with VISNs and VAMCs
    Challenges (cont’d)
  • 24. Advances and Initiatives
  • 25. Facilities
    • Facilities Infrastructure
      • Outdated physical structure
      • Research facilities ages average 49 yrs
    • Limited funding
    • Formal congressionally mandated infrastructure assessment process has been underway
      • Review of previous surveys, site visits, etc
    • Recent improvement
  • 26.
    • Improved collaborations within ORD & VHA and with DoD, other federal agencies and the private sector
    • Organizational Improvements
      • Second Deputy CRADO – for Field
      • Program Manager changes
    • On-line grant submission (eRA Commons)
    • Central IRB
    Administrative Advances
  • 27.
    • Communications
    • Internal integration/communication with VISNs and VAMCs
      • Research Accountability Meeting 2009 included MCD, COS
      • ORD leadership plans to visit each VISN Director
    • ACOS/AO/RCO meeting
    • Research Administrative Review
    • Blue Ribbon Panel
    Administrative Advances (cont’d)
  • 28. Blue Ribbon Panel The Report of the Blue Ribbon Panel on VA-Medical School Affiliations Transforming an Historic Partnership for the 21 st Century “… VA and its academic partners redouble their efforts to develop new knowledge through collaborative research.” ..VA review and, whenever possible, modify policies and procedures that limit effective collaboration with its academic affiliate in patient care, education, and research.”
  • 29. Blue Ribbon Panel
    • Accepted by the Secretary
    • Implementation Plan drafted
    • External (FACA) Advisory Committee being assembled
  • 30. VA Research Administrative Review
    • Purpose – Address issues regarding administration of research in Medical Centers and VISNs
      • Governance
      • Compliance
      • Researchers and research implementation
      • Maintaining human capital resources
    • Structure
      • Membership - VISN Directors, MCDs, CMOs, COS, ACOS/Rs, AOs, RCOs and researchers
      • Steering Committee
        • Governance Subcommittee - Chair, Randy Petzel
        • Human Capital Subcommittee – Chair, Jack Hetrick
  • 31. VA Research Administrative Review
    • First report
      • Roles of VISN and Medical Center leadership positions in research
      • Research performance expectations of VHA leaders
      • Responsibility of R & D Committee
      • Mentoring and training
    • Second Report approved by HSC Committee of NLB
      • ACOS/R, AO responsibilities
      • R & D Committee specifics
      • Role of ACOS/R in MCD leadership
      • Recruitment, retention and support of investigators
      • Time allocation for research efforts
      • VA research principles
  • 32. Health Services Research Work Group
    • Work Group consists of VHA clinical, health system and research leaders
    • To address questions including
      • How can HSRD best serve to improve the healthcare system?
      • How can HSRD do so using the highest quality, unbiased methods?
      • How does HSRD play a role in emerging changes such as the Medical Home?
      • How can research & the Health Care System better collaborate?
    • Important future impact
  • 33. IT Projects
    • Workgroup including VHA, OIT and universities convened by AAMC
      • Policies and procedure for sharing data
      • Consented & Non-consented research
      • Checklist
    • On-line grants submission implemented – eRA
    • NIH IT reporting tool is undergoing evaluation
  • 34.
    • Comparative Effectiveness Research
    • Genomic Medicine
    • Post-Deployment Research
    A Look to the Future
  • 35. Comparative Effectiveness Research
  • 36. Comparative effectiveness research (CER) is the generation and synthesis of evidence that compares the benefits and harms of alternative methods to prevent, diagnose, treat and monitor a clinical condition or to improve the delivery of care. National Priorities for Comparative Effectiveness Research Institute of Medicine Report Brief June 2009 Comparative Effectiveness Research
  • 37. Randomized comparisons of treatments, which could be very different from each other Drugs vs. surgery Surgery vs. device Behavioral therapy vs. pharmacological therapy Real world experiments applicable to clinical practice Community based medical centers Large numbers of patients Broad eligibility criteria Patient centered outcomes: mortality, morbidity Typical of the conducted by VA CSP Comparative Effectiveness Research
  • 38.
    • Interest in and movement to Comparative Effectiveness Research will change the way we approach and do research
      • Evaluation via CER will be more prominent
      • How research projects are identified and chosen
      • What research methodology is accepted
        • Moving beyond the Randomized Controlled Trial
    • VA has already made progress in these areas
    Influence of CER on the Research Establishment
  • 39. VA Infrastructure Reflects Needs in FCC CER Report
    • FCC CER report outlined infrastructure needs for CER: These infrastructure capabilities already exist in VA
      • Clinical research network
      • Registries, surveillance databases, research-quality observational datasets
      • Administrative databases
      • EHRs & distributed data networks
      • Tools for dissemination and translation of research findings
      • Human and scientific capital
        • Clinician/Researchers – 70% of VA researchers
        • Training (e.g. Research Career Development Awards)
        • Patient/consumer engagement
  • 40. VA Cooperative Studies Program
    • Large VA clinical trials program
      • Major vehicle for Comparative Effectiveness Research
    • Method of funding projects
      • Letter of intent submitted
        • Ideas based on clinical practice observations, gaps in literature, etc
      • Project review by experts who collaborate with the proposer
        • Include clinicians, clinical researchers, trialists, biostaticians, pharmacists, others
    • Review considerations include clinical and policy considerations
      • Clinical relevance and importance to VHA population, methodology, feasibility (testable hypothesis, sample size), ethics, resources needed, investigator qualifications
    • Central IRB approval
    • CSP Center expertise – fixed structure for every project
      • Economics, project management, informatics, etc
  • 41.
    • Quality Research Enhancement Initiative
    • Evidence Synthesis Program
      • Policy oriented synthesis of evidence to inform medical practice and health systems planning
        • Informed by policy considerations with input by Patient Care Services
      • Recent topics
        • Drug management of BPH – Led to Formulary change
        • Osteoporosis – Incorporated into Guideline on screening male Veterans
        • Pain in Polytrauma – Need more research
    Implementation/ Translation
  • 42. Results of Comparative Effectiveness Research
    • Informed choices for Patients, Providers, Healthcare system
    • Informed choices will involve a complex of interacting and coalescing research vehicles
      • Comparative Effectiveness Research
      • Research related to Personalized/Individualized Medicine
        • Genomics and other approaches to examine the individual in his person and setting (genetic make-up, coexisting conditions, location, etc)
    • Comparative Effectiveness Research will continue to be a major VA endeavor
  • 43. Genomic Medicine Program
  • 44.
    • Collect and link genetic information with VA Electronic Health Record and thereby:
      • Discover genetic predispositions, causes and mechanisms of disease
      • Better define treatments
        • Pharmacogenomic & interventional customization
      • Via research, advance understanding in all these areas
    • Establish how genetic information will be used in clinical medicine
      • Translational research to link genotype to phenotype
      • Complex, adult, multi-gene diseases possibly with strong environmental influences
    Goals of VA Genomic Medicine Program
  • 45.
    • Enlarge infrastructure
      • Pharmacogenomic laboratory, Enlargement of genetic storage capacity, IT projects (GeniSIS)
    • Collaborations – NIH, HHS
    • Translation into clinical practice
      • Educational programs for health professional with Nat'l Coalition for Health Prof Educ in Genetics
    • Address privacy/ethical issues
      • Veterans Consultation Project
      • Consent process
    • Large scale projects
    Genomic Medicine Initiative Steps in Implementation
  • 46.
    • Veterans consultation project
      • Collaboration with VSOs
      • Consulting group engaged to establish Focus Groups to solicit opinions, beliefs, and values of individual Veterans
    • Veterans recruited through:
      • Local VSOs chapters
      • VAMCs, VA Community-Based Outpatient Clinics and VET Centers (Readjustment Counseling Centers)
    • Focus Groups met Sept-Nov, 2007
    • Internet survey performed April 24 – May 5, 2008
      • N = 931
    Veterans Consultation Project
  • 47. Confidential. N=931. Weighted. GPPC 2008 Based on what you’ve just learned, do you think the Genomic Medicine Program should be done? Definitely Yes Probably Yes Definitely No Probably No
  • 48. I am curious about the influence of genes on health Participating would make me feel like a guinea pig 37% 83% When thinking about participating in the program, do you agree or disagree with the following statements? 78% Participating would be easy Participating would make me feel I was helping Veterans 86% 48% 63% 17% 22% 14% 52% I would be concerned info could be used against me 50% 50% I would be concerned about govt having my samples Confidential. N=931. Weighted. GPPC 2008 Agree Disagree Strongly Disagree Disagree Agree Strongly Agree
  • 49.
    • Receiving information about my health
    • Knowing what kind of research being done using the database
    • Knowing who to go to with a question or complaint
    • Having my privacy protected
    • Having a mechanism to change my mind and withdraw my sample and information at a later time
    • Monetary compensation for my time
    In deciding whether to participate or not, how important would the following be to you? 96% 95% 94% 93% 86% 60% % Confidential. N=931. Weighted. GPPC 2008
  • 50. Academic or medical centers in other countries US academic or medical centers No Yes 80% Do you think the following types of researchers outside of the VA should be able to use the GMP db and samples? 54% US pharmaceutical companies 43% 70% 20% 46% 57% 30% Other health-related govt. agencies Confidential. N=931. Weighted. GPPC 2008
  • 51.
    • Serious consequences for researchers who violate my research agreement
    • VA have safeguards to protect information from misuse and disclosure
    • There would be a research agreement signed by researchers and participants
    • It would be illegal for insurers and employers to get my information
    • It would be illegal for law enforcement to get my information
    If you were a participant, how important would the following be to you? 98% 98% 97% 95% 87% % Confidential. N=931. Weighted. GPPC 2008
  • 52.
    • 83% said program should be done
    • 71% would participate
    • Participation associated with
      • Attitudes about research
      • Attitudes about helping and history of previous “altruistic behaviors”
      • Curiosity about genetics
      • Satisfaction with VA
      • Demographic differences
    Summary of Genomics Survey Findings
  • 53. Cloning Confidential. N=931. Weighted. GPPC 2008 Stem cell research Athletic ability Suscept. to env. exp. Alcoholism PTSD Mental illness Cancer Do you think research should be allowed or prohibited on: (% allowed)
  • 54.
    • Focus group results – Quote
      • "The fact that they have people sitting around talking about this in advance of even starting to build it tells me that they're paying attention...This right here is oversight, you know, at the get-go. So I think that that's a really good thing; and I think ultimately it's going to be one more way that Veterans give something from themselves to make this country better."
    Veteran Attitudes
  • 55.
    • Discoveries
      • Schizophrenia & the alpha-7-Nicotinic acid gene
      • Alzheimer’s - Presenilin and Tau genes
      • HIV susceptibility - Immune-response gene CCL3L1
      • Type-2 Diabetes genes (6) in Mexican Americans
      • Childhood anxiety disorders
    • Ongoing projects
      • PTSD - Serotonin and Dopamine transporter genetics
      • Cholesterol disorders
      • Alcohol consumption and withdrawal
      • Bipolar Disorder
      • Coronary disease in Mexican-Americans
      • Gulf War Veterans Illness
    VA Genomics Project Discoveries and Projects
  • 56.
    • Large scale Studies/Databases
      • Serious Mental Illness - Schizophrenia and Bipolar Disorder
      • Deployment-related mental illness - PTSD resilience
      • Amyotrophic Lateral Sclerosis
    • Million Veteran Project (MVP)
      • Start of large Population (Non disease-specific) Genomic Database
      • Comprehensive, interdisciplinary data collection and analysis on 1,000,000 Veterans
      • Will change the way research is conducted
      • Will change the way medicine is practiced
    Genomic Medicine Initiative Large Scale Projects
  • 57. IT Projects
    • VINCI – Veterans’ Informatics, Information & Computing Infrastructure
      • Development of de-identified Corporate Data Warehouse for storing and managing clinical (and genomic) data
      • Surveillance – capture of early trends post deployment
    • CHIR – Consortium for Healthcare Informatics Research
      • Electronic text interpretation of HER
    • GenISIS – Genomic Information System for Integrative Science
      • Incorporation of genomic data into the HER
      • Repurpose data and results for secondary analyses
      • Validate genomic medicine findings
      • Integrate findings into clinical medicine
  • 58. OEF/OIF and Other Post-Deployment Research
  • 59.
    • Deployment-related research – current and all conflicts
      • Prosthetics
      • Hearing and vision research
      • PTSD
      • Rehabilitation
      • Environmental exposures
    • Deployment-related research highlighting specifics for current conflicts
      • Traumatic Brain Injury and other Neurotrauma
      • Polytrauma
      • Access
      • Chronic care and the new Veteran
      • Homelessness
    • Collaborations with DoD
    OEF/OIF and Other Post-Deployment
  • 60.
    • Homelessness
      • Initiative to eliminate homelessness of Veterans in 5 years
      • Research agenda involves medical research plus social signs, economics, etc.
      • Collaborations will be important
    • Environmental exposures
      • Agent Orange
      • Gulf War
      • Burn pits
    Secretarial Initiatives
  • 61. Modular Upper Limb VA, DARPA and Industry Stage 1: “Strap and go” device that operates with advanced gyroscope technology Stage 2: Arm controlled by brain-computer interface
  • 62. Electronic Ankle-Foot Prosthesis May Improve Mobility of Veteran Amputees Dr. Hugh Herr
  • 63. Hearing and Vision
    • VA Center of Excellence in Hearing Loss Rehabilitation
      • Unique resource addressing the single largest cause of disability among Veterans
    • VA Center on Aging and Vision Loss
      • Examines the role of environment in visually impaired Veterans and conducts clinical trials to improve vision
    • VA Center of Excellence in Advanced Vision Rehabilitation
      • Developing a prosthetic retinal implant for retinal disorders
  • 64. TBI/Polytrauma Research
  • 65.
    • Developing adult stem cell technology to protect and reverse effects of brain trauma
    • Nerve damage repair after brain injury & effectiveness of interventions
    • Impact of rehab strategies on the brain after TBI
    • Pain management
    • Effects of concurrent PTSD on TBI outcomes
    • Magnetic brain stimulation to improve rehabilitation
    • Gate, balance and attention demands and TBI Mechanisms to enhance cognitive rehabilitation
    • Various imaging studies
    • Identifying and screening for mild TBI
    TBI/Polytrauma Research
  • 66. Post Traumatic Stress Disorder
  • 67.
    • Neurophysiology
    • Imaging
    • Treatments (Prazocin for nightmares, respiridone, cycloserine)
    • Comparison of virtual reality graded exposure therapy with cognitive behavioral group therapy
    • Approaches to PTSD post military sexual trauma
    • Developing models of care including telemedicine and collaborative care approaches to increase access
    • Cohort to examine PTSD & TBI established prior to deployment and followed post deployment
    • Biomarkers – genetic, CNS structural and reactivity
    • PTSD complicated by substance abuse
    • Vocational rehabilitation
    • Genetic database
    Post Traumatic Stress Disorder
  • 68. VA Leadership Role in PTSD
  • 69.
    • Congressionally Directed Medical Research Programs (CDMRP)
      • Substantial funding for TBI and PTSD
      • VA has considerable involvement in planning and study sections and has won numerous awards (44%)
    TBI/Polytrauma Research
  • 70.
    • Access to Care
      • ORD has a well established portfolio in access which been applied to OEF/OIF Veterans
    • Interventions to improve community and family reintegration
      • Including pro-active case management, mental health, social and occupational functioning and the needs of care givers
      • Vocational rehabilitation
    • OEF/OIF Advisory Committee to NRAC
      • Includes DoD
      • Review and advise re OEF/OIF portfolio including gaps between and overlaps with DoD
    Other Programs for the Returning Veterans