VA Research & Development Program

VA Research & Development Program

Robert Jaeger, PhDRobert Jaeger, PhDRR&D Scientific Program ManagerRR&D Scientific Program Manager

VA Research Mission

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

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

Rich 60 Year History

• 3 Nobel Laureates, 6 Lasker Award Winners• Important Discoveries and Inventions

o Devices Cardiac Pacemaker First liver transplant Radioimmunoassay CT Scanner

o Treatments TB – First large scale clinical trial Cooperative Studies Program – Trials strongly influence

medical practice

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

Intramural Research Program

• VA Research is an intramural programo 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

Intramural Research Program

• VA Research connected directly to nation’s largest health system (being “Intramural”)o >70% of investigators are clinicianso Links researchers directly to Veterans’ needso Facilitates implementation of research results

• Unique research resources includeo Electronic Health Record o Cooperative Studies Program – Clinical Trialso Telemedicine o Drug safety centero Rehabilitation research

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 yearso Publish in the best journals

• Broad, extensive research portfolio that balances the needs of all veterans

• Best buy in government

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

Facilities

• Facilities Infrastructureo Outdated physical structureo Research facilities ages average 49 yrs

• Limited funding• Formal Congressionally mandated

infrastructure assessment process is underwayo Review of previous surveys, site visits, etc

ORD Initiatives in Research Compliance

• New Directives in concurrenceo Responses to FDA safety info (with PBM)

Closer collaboration of ORD with PBMo Response to SAE reports in studieso Compliance auditing (with ORO)o Research Participant Outreach Program

(ORD)

• Committee on Funding

Compliance Initiatives

Compliance Initiatives

• Facilities must have a Research Compliance Officero Performance Measure for VISN and MC

Directors

• Cooperative Studies Programo Data integrity audit program - SMRTo Unannounced auditso Revision of CSP Handbook 1205o IT plan for CSP

VA Research Administrative

Review

VA Research Administrative Review• Purpose – Address issues regarding

administration of research in Medical Centers and VISNs o Governanceo Complianceo Researchers and research implementation

• Structureo Membership - VISN Directors, MCDs, CMOs,

COS, ACOS/Rs, AOs, RCOs and researcherso Steering Committee

Governance Subcommittee - Chair, Randy Petzel Human Capital Subcommittee – Chair, Jack Hetrick

o Reports to Health Services Committee and National Leadership Board

VA Research Administrative Review

• Governance and Human Resources Subcommittee activitieso Recruitment, retention and support of

investigatorso Roles of VISN and Medical Center leadership

positions in researcho Research performance expectations of VHA

leaderso Reporting lineso Responsibility of R & D Committeeo Time allocation for research effortso Responsibilities concerning compliance

Research Accountability Meeting• Research Accountability Meeting

2009o Was held January 13, 14th 2009o Includes MCDs, COS, ACOS/R, AO, RCOo Over 600 attendeeso Novel designo Interactive meetingo Follow-up in VAMCs

Other Recent Administrative

Advances

• Improved collaborations within ORD & VHA and with DoD, other federal agencies and the private sectoro CDMRP

• Organizational Improvements• Communications• Central IRB – Important to multisite studies• On-line grant submission• IT

Administrative Advances

VA Central IRB

• VA Central IRB has been launched• Unique VA entity for multi-site trials• Purposes

o Improve human research protectiono Highest quality human subject protectiono Efficiencyo Centralized accountability

• First meeting December 21-22, 2007 o 9 meetings so far

• First protocol reviewed August 12, 2008

Online Grants Application Process• NIH Electronic Research Administration

(eRA) System launchedo Electronic processing system for grant

submissiono Streamline ORD proposal review and

management processes • One common submission process for all

ORD proposalso Implemented in HHS (CDC, AHRQ, FDA)

• Alternate Activity Code approved by NIHo Activity Code IO1

IT Security

• Working Groups formed to examine research and education IT issueso 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

OEF/OIF

Improved Survival

0

5

10

15

20

(%)

WWII Vietnam OIF/OEF

Percent of Fatal Casualties

Halcomb et al, J Trauma 2006; 60:397

19.1

15.8

9.4

• Deployment-related research – current and all conflicts

o Prostheticso Hearing and vision researcho PTSD o Rehabilitation

• Deployment-related research highlighting specifics for current conflicts

o Traumatic Brain Injury and other Neurotraumao Polytraumao Accesso Chronic care and the new veteran

• Collaborations with DoD

OEF/OIF

• 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

• 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 releasedo Veteran centrico Include all serviceso Address problems

TBI/Polytrauma Research

Attributes for Comparative Effectiveness Research

• VA attributes for Comparative Effectiveness Research for the benefit of veteranso Large healthcare systemo Outstanding research program embedded

in healthcare system - “Intramural”o Infrastructure for clinical trialso Vehicles for translation and

implementation of research into the health care system

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 programo Evidence Based Synthesis program

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 Centerso 4 Epidemiology Research Centerso Pharmacy Coordinating Centero Health Economics Resource Centero Pharmacogenomics Analysis Laboratory

QUERI Program

• Mission - Systematically implement/ translate evidence-based clinical practices & research findings into routine clinical practice

• Steps in QUERI processo Identify gap in Evidence Based Practiceo Develop and implement a strategy for changeo Test strategy

Single site pilot Small scale implementation pilot Large scale, multi-region implementation trial System-wide roll-out

o Document system improvementso Document outcomes & QOL improvements

SCI/Regen Med

Audrey Kalehua

SCI/Regen Med

Audrey Kalehua

Prosthetics/Rehabil Engineering

Bob Jaeger

Prosthetics/Rehabil Engineering

Bob Jaeger

Rehab R&D Scientific Rehab R&D Scientific OrganizationOrganization

Director, Mickey SelzerDirector, Mickey SelzerDeputy Director, Tricia DornDeputy 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/Social Reintegration/Mental HealthMental Health

Sunil Sen-GuptaSunil Sen-Gupta

Social Reintegration/Social Reintegration/Mental HealthMental Health

Sunil Sen-GuptaSunil Sen-Gupta

Career Develop/Career Develop/Special ProjectsSpecial ProjectsJay FreedmanJay Freedman

Musculoskel/Musculoskel/Med ComorbidityMed Comorbidity

Tom PierceTom Pierce

Musculoskel/Musculoskel/Med ComorbidityMed Comorbidity

Tom PierceTom Pierce

NeuroplasticityNeuroplasticity//

PT, OT, PT, OT, etc.etc.PendingPending

NeuroplasticityNeuroplasticity//

PT, OT, PT, OT, etc.etc.PendingPending

SensorySensorySystemsSystemsPendingPending

SensorySensorySystemsSystemsPendingPending

Prostheses

Electronic Electronic Ankle-Foot Ankle-Foot Prosthesis Prosthesis May Improve May Improve Mobility of Mobility of Veteran Veteran AmputeesAmputees

Pause for Video Clip

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

• Personalized medicine as a research agendao How do we “personalize” the research agenda?

E.g. Rehabilitation, Polytrauma, Geriatrics

• Some issueso RCT only deals with averages

E.g. ICD in subgroups

o Research using small numberso 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

• Some steps in Personalized Researcho 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

robert.jaeger@va.gov

Contact