VA COOPERATIVE STUDIES PROGRAM

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VA COOPERATIVE STUDIES PROGRAM

• Grant D. Huang, MPH, PhD
• VA Office of Research and Development
• Washington, DC

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VETERANS HEALTH ADMIN Office of Research
Development
Biomedical Laboratory RD
Rehabilitation RD
Clinical Science RD
Health Services RD
Cooperative Studies Program
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Clinical Science Research DevelopmentDirector
Timothy J. OLeary, MD, PhD

• Develops, administers, and coordinates single and
  multi-center clinical trials and observational
  studies within the VA health care system.
• Research emphases
• efficacy and cost effectiveness of new
  medications and treatment strategies
• risk factors for disease and disorders impacting
  veterans
• patient-centered outcomes with potential
  implications for clinical practice
• Intramural funding program
• VA investigator initiated
• Request for proposals (RFPs)

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CSRD PROGRAMS

• Merit Review Program
• Clinical Trials
• Epidemiology
• Joint disease-focused subcommittees with BLRD
• Career Development Program
• Cooperative Studies Program
• Integrated with programs in Gulf War research
  and genomic medicine

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VA COOPERATIVE STUDIES PROGRAM

• MISSION To advance the health and care of
  veterans through collaborative research studies
  that produce innovative solutions to national
  health care problems.
• Infrastructure for conducting multi-site clinical
  trials
• Questions studied in a uniform manner using a
  common protocol
• Facilitates accumulation of patients across
  multiple sites to provide definitive answers
• Central coordination
• Epidemiological population research

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CSP HISTORY

• 1940s - First Cooperative Study conducted
  involving streptomycin for treating tuberculosis
  in WWII veterans
• 1972 CSP established in modern format as a
  clinical trials program for VA
• 1998 Epidemiological research centers
  established to broaden the clinical research
  scope of CSP
• 1999 CSP DNA Bank approved and funded
• 2003 CSP integrated into Clinical Science RD
  Service
• 2007 Pharmacogenomics Analysis Laboratory
  established
• Over 175 clinical trials and observational
  studies completed including major studies in
  cardiovascular disease / cardiovascular surgery,
  infectious diseases, surgery, gastroenterology,
  mental health, oncology, endocrinology

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CSP INFRASTRUCTURE

• 5 data/statistical coordinating centers
• 4 epidemiology research centers
• Clinical Research Pharmacy Coordinating Center
• Health Economics Resource Center
• DNA Bank / Biospecimen Repository
• Pharmacogenomics Analysis Lab
• Biostatistical / epidemiological expertise
• Clinical expertise
• Pharmaceutical management
• Safety and regulatory oversight
• Health economics expertise
• Biospecimen management
• Clinical research project/fiscal management

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CSP CENTER LOCATIONS
Seattle, WA
Boston, MA
West Haven, CT
Perry Point, MD
Hines, IL
Washington, DC
Palo Alto, CA
Durham, NC
Albuquerque, NM
Little Rock, AR
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CSP STUDIES

• 31 active studies/projects
• 5 cancer
• 5 general and cardiac surgery
• 4 mental health/substance abuse
• 4 neurology
• 3 cardiovascular
• 2 renal
• Others include
• infectious disease
• diabetes
• COPD
• genetics
• spinal cord injury
• rheumatoid arthritis
• nutrition in elderly transitional care unit
  patients

As of 10/2007
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CSP DNA BANK STUDIES

• 14 on-going / completed studies with DNA
  collected
• Cardiovascular disease
• Kidney disease
• Cancer (skin, prostate)
• Mental health (PTSD)
• Rheumatoid arthritis
• Alzheimers Disease
• Amyotrophic Lateral Sclerosis
• Over 6000 consented patients

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COLLABORATIONS

• National Institutes of Health
• NIDA, NINDS, NIDDK, NHLBI, NCI, NIAMDS, NIMH,
  NIDCD
• Department of Defense
• Universities
• Industry
• International
• Canadian Institutes of Health Research
• United Kingdom Medical Research Council

Mechanisms established to facilitate
collaborations
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CSP FUNDING SOURCES

• P825 (Research Appropriation)
• Program Funding
• Travel
• P870 (Patient Care Services Appropriation)
• COOP
• COOP Diabetes
• Genomic Medicine
• IT Appropriation
• Reimbursable (via Interagency Agreements)
• Program Funding
• IT
• Non-Profit Corporations

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Recent CSP Publications

• CSP 453 (HOST) Effect of homocysteine lowering
  on mortality and vascular disease in advanced
  chronic kidney disease and end-stage renal
  disease (JAMA Sept 2007)
• CSP 458 Mental health of US Gulf War Veterans
  psychological evaluation 10 years after the war
  (Br J Psychiat May 2007)
• CSP 424 (COURAGE) Optimal medical therapy with
  or without PCI for stable coronary disease (NEJM
  March 2007)
• CSP 410 (FeAST) Reduction in iron stores and
  cardiovascular outcomes in peripheral artery
  disease (JAMA Feb 2007)
• CSP 494 Cognitive behavioral therapy for PTSD
  in women (JAMA Feb 2007)

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CSP News Makers
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CSP MERIT REVIEW SYSTEM
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COOPERATIVE STUDIES SCIENTIFIC MERIT REVIEW BOARD

• Multidisciplinary review board comprised of
  experts in various medical specialties,
  biostatistics, and epidemiology
• Surgery, internal medicine, neurology,
  cardiology, psychiatry
• Ad hoc as needed
• Reviews full protocol after LOI / planning stages
  completed
• Dynamic review process
• Study proponents present defend proposals
  before board
• Interactive discussion on approaches to study
  execution

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REVIEW CONSIDERATIONS

• Clinical relevance (to Veteran population)
• Methodology
• Study design, randomization, endpoints, analysis
  plan
• Feasibility
• Testable hypothesis, sample size, execution plan
• Ethics
• Resources needed
• Investigator qualifications

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CSP STUDY PERSONNEL

• Study Chairperson
• Study Biostatistician
• Clinical Research Pharmacist
• Health Economist
• Executive Committee
• Project Manager
• Site Investigators
• Clinical research nurses / site coordinators
• Data Safety Monitoring Board
• Human Rights Committee
• Quality Assurance Officers Site Monitors
• ALL contribute to the success of the clinical
  trial

? TEAMWORK AND COOPERATION IS KEY
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FUTURE DIRECTIONS

• Two studies in planning related to genetic
  factors in schizophrenia / bipolar disorder and
  PTSD
• CSSMRB subcommittee on genomic research being
  established in FY08
• New studies and substudies of main CSP trials
• Analytical and logistical processes to be
  developed between Biorepository and PAL
• Planning ? collection ? analyses
• Identification and recruitment of genetic
  statisticians for CSP Centers

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• Contact Information
• Cooperative Studies Program (125)
• VHA Office of Research Development
• 810 Vermont Ave, NW
• Washington, DC 20420
• Phone [phone]
• E-mail CSP_at_va.gov
• Website http//www.vacsp.gov