1. VA Research & Development Program Robert Jaeger, PhD RR&D Scientific Program Manager

2. VA Research Mission Mission: “To discover knowledge and create innovations that advance the health and care of Veterans and the nation.”

3. VA Research Standards Is the research based on rigorous science? Will the research produce data that drives clinical policy and translates to improved health care? Will the research help Veterans? o Is it Veteran-centric? o The only research program focused entirely on Veteran’s needs

4. Rich 60 Year History 3 Nobel Laureates, 6 Lasker Award Winners Important Discoveries and Inventions oDevices  Cardiac Pacemaker  First liver transplant  Radioimmunoassay  CT Scanner oTreatments  TB – First large scale clinical trial  Cooperative Studies Program – Trials strongly influence medical practice

5. Rich 60 Year History (cont) First rehabilitation program for blind persons Linked smoking with cancer of the respiratory tract and lung Developed the nicotine patch for smoking cessation Found that the insulin pump controls diabetics blood sugar and weight better than multiple daily injections Identified best treatments for colon cancer, psychoses, stable angina, high blood pressure and other conditions Developed a computer-controlled ventilator system for critically ill patients Developed the Seattle Foot

6. Intramural Research Program VA Research is an intramural program o Researchers must be employed by VA (usually 5/8s or more) o Having research and clinical care under the same roof is a unique strength

7. Intramural Research Program VA Research connected directly to nation ’ s largest health system (being “ Intramural ” ) o >70% of investigators are clinicians o Links researchers directly to Veterans ’ needs o Facilitates implementation of research results Unique research resources include o Electronic Health Record o Cooperative Studies Program – Clinical Trials o Telemedicine o Drug safety center o Rehabilitation research

8. Intramural Research Program 117 VAMCs have capacity for research ≈100 are funded by ORD at any time ≈2000 ORD funded projects Community of ≈3000 VA researchers with a long history of significant research o Published 46,149 articles in past 7 years o Publish in the best journals Broad, extensive research portfolio that balances the needs of all veterans Best buy in government

9. Research Services Basic Laboratory R & D Clinical Science R & D o Cooperative Studies Program – Large clinical trials Rehabilitation R & D Health Services R & D o Quality Enhancement Research Initiative (QUERI) – Implementation research in which VA is the pioneer

10. Facilities Facilities Infrastructure o Outdated physical structure o Research facilities ages average 49 yrs Limited funding Formal Congressionally mandated infrastructure assessment process is underway o Review of previous surveys, site visits, etc

11. ORD Initiatives in Research Compliance

12. New Directives in concurrence o Responses to FDA safety info (with PBM)  Closer collaboration of ORD with PBM o Response to SAE reports in studies o Compliance auditing (with ORO) o Research Participant Outreach Program (ORD) Committee on Funding Compliance Initiatives

13. Facilities must have a Research Compliance Officer o Performance Measure for VISN and MC Directors Cooperative Studies Program o Data integrity audit program - SMRT o Unannounced audits o Revision of CSP Handbook 1205 o IT plan for CSP

14. VA Research Administrative Review

15. Purpose – Address issues regarding administration of research in Medical Centers and VISNs o Governance o Compliance o Researchers and research implementation Structure o Membership - VISN Directors, MCDs, CMOs, COS, ACOS/Rs, AOs, RCOs and researchers o Steering Committee  Governance Subcommittee - Chair, Randy Petzel  Human Capital Subcommittee – Chair, Jack Hetrick o Reports to Health Services Committee and National Leadership Board

16. VA Research Administrative Review Governance and Human Resources Subcommittee activities o Recruitment, retention and support of investigators o Roles of VISN and Medical Center leadership positions in research o Research performance expectations of VHA leaders o Reporting lines o Responsibility of R & D Committee o Time allocation for research efforts o Responsibilities concerning compliance

17. Research Accountability Meeting Research Accountability Meeting 2009 o Was held January 13, 14 th 2009 o Includes MCDs, COS, ACOS/R, AO, RCO o Over 600 attendees o Novel design o Interactive meeting o Follow-up in VAMCs

18. Other Recent Administrative Advances

19. Improved collaborations within ORD & VHA and with DoD, other federal agencies and the private sector o CDMRP Organizational Improvements Communications Central IRB – Important to multisite studies On-line grant submission IT Administrative Advances

20. VA Central IRB VA Central IRB has been launched Unique VA entity for multi-site trials Purposes o Improve human research protection o Highest quality human subject protection o Efficiency o Centralized accountability First meeting December 21-22, 2007 o 9 meetings so far First protocol reviewed August 12, 2008

21. Online Grants Application Process NIH Electronic Research Administration (eRA) System launched o Electronic processing system for grant submission o Streamline ORD proposal review and management processes One common submission process for all ORD proposals o Implemented in HHS (CDC, AHRQ, FDA) Alternate Activity Code approved by NIH o Activity Code IO1

22. IT Security Working Groups formed to examine research and education IT issues o VHA, OIT and universities convened by AAMC  First meeting September 17 o Initiatives to improve data storage and retrieval and make other IT improvements for research use Clinical monitor directive Patient choice re personal data

23. OEF/OIF

24. Improved Survival Halcomb et al, J Trauma 2006; 60:397 19.1 15.8 9.4

25. Deployment-related research – current and all conflicts o Prosthetics o Hearing and vision research o PTSD o Rehabilitation Deployment-related research highlighting specifics for current conflicts o Traumatic Brain Injury and other Neurotrauma o Polytrauma o Access o Chronic care and the new veteran Collaborations with DoD OEF/OIF

26. 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 Gait, balance and attention demands and TBI Mechanisms to enhance cognitive rehabilitation Various imaging studies Identifying and screening for mild TBI TBI/Polytrauma Research

27. TBI State of the Art Conference April 30 – May 2, 2008 Brought together best researchers from VA, DOD and civilian sector to evaluate research in TBI and recommend a future research agenda RFA based on this conference has been released o Veteran centric o Include all services o Address problems TBI/Polytrauma Research

28. Attributes for Comparative Effectiveness Research VA attributes for Comparative Effectiveness Research for the benefit of veterans o Large healthcare system o Outstanding research program embedded in healthcare system - “Intramural” o Infrastructure for clinical trials o Vehicles for translation and implementation of research into the health care system

29. VA Comparative Effectiveness Research Research o Clinical trials  Cooperative Studies Program  Health Services Research – health system oriented research  Rehabilitation Implementation o Quality Enhancement Research Initiative program o Evidence Based Synthesis program

30. VA Cooperative Studies Program Large VA clinical trials program Major vehicle for Comparative Effectiveness Research Organization o Headquarters – Central Office, under Office of R & D o 5 Data and Statistical Coordinating Centers o 4 Epidemiology Research Centers o Pharmacy Coordinating Center o Health Economics Resource Center o Pharmacogenomics Analysis Laboratory

31. QUERI Program Mission - Systematically implement/ translate evidence- based clinical practices & research findings into routine clinical practice Steps in QUERI process o Identify gap in Evidence Based Practice o Develop and implement a strategy for change o Test strategy  Single site pilot  Small scale implementation pilot  Large scale, multi-region implementation trial  System-wide roll-out o Document system improvements o Document outcomes & QOL improvements

32. SCI/ Regen Med Audrey Kalehua SCI/ Regen Med Audrey Kalehua Prosthetics/ Rehabil Engineering Bob Jaeger Prosthetics/ Rehabil Engineering Bob Jaeger Rehab R&D Scientific Organization Director, Mickey Selzer Deputy Director, Tricia Dorn Aging/ Neurodegen Dis Tshaka Cunningham Aging/ Neurodegen Dis Tshaka Cunningham Brain Injury/ Stroke Jean Langlois Brain Injury/ Stroke Jean Langlois Social Reintegration/ Mental Health Sunil Sen-Gupta Social Reintegration/ Mental Health Sunil Sen-Gupta Career Develop/ Special Projects Jay Freedman Musculoskel/ Med Comorbidity Tom Pierce Musculoskel/ Med Comorbidity Tom Pierce Neuroplasticity / PT, OT, etc. Pending Neuroplasticity / PT, OT, etc. Pending SensorySystemsPendingSensorySystemsPending

33. Prostheses

35. Electronic Ankle-Foot Prosthesis May Improve Mobility of Veteran Amputees

36. Pause for Video Clip

37. Prosthetic Retina May Restore Vision to Veterans with Retinal Degeneration Transmission coil for data and power (wireless transmission) Receiving coil for data and power Miniature camera mounted on a pair of glasses (sends image to transmission coil) Chip and electrode array connected to coil CCD

38. Personalized medicine as a research agenda o How do we “personalize” the research agenda?  E.g. Rehabilitation, Polytrauma, Geriatrics Some issues o RCT only deals with averages  E.g. ICD in subgroups o Research using small numbers o Research on such topics as models of care, care giving, long-term care, etc. o Research that takes into account individual differences  Complex, multisystem diseases, etc Personalized Research

39. Some steps in Personalized Research o Improve research capabilities of EHR  Informatics Consortium – collaboration with IT  Natural language processing and indexing o Reengineering of research approaches  Exploration of new research methodology, etc o Explore biological mechanisms, models of care, etc. Use of VA’s brainpower Personalized Research

40. robert.jaeger@va.gov Contact