Clinical and Translational Research at Vanderbilt

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Clinical and Translational Research at Vanderbilt
Gordon Bernard MD Professor of Medicine Assistant
Vice-Chancellor for Clinical Research
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S.E.1 GCRC Inpatient and OutpatientUtilization
Diversity 2000-2006
S.E.2 GCRC Pediatric Research
(N 69, most recent 12 months)
S.E.3 GCRC Inpatient and Outpatient Clinical
Research Portfolio By Category
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CTSA A roadmap initiative
It is the responsibility of those of us involved
in todays biomedical research enterprise to
translate the remarkable scientific innovations
we are witnessing into health gains for the
nation.
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Vanderbilt Institute for Clinical and
Translational Research(VICTR)
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NIH CTSA Awards A Home for Clinical and
Translational Science
Clinical Research Ethics
Trial Design
Advanced Degree-Granting Programs
Biomedical Informatics
CTSA HOME
Participant Community Involvement
Clinical Resources
Biostatistics
Regulatory Support
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Impediments to translation
Current Situation
Small proportion translated
Large number of ideas
T1 and T2 blocks are psychological,
organizational, procedural and physical
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Organizational Chart for VICTR Administration
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COMMUNITY!
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1. Access to pilot funds
2. Biostatistics core support
3. Synthetic derivative
4. Database of collaborators
very beneficial
N575
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Voucher System

• Designed to facilitate support for innovation.
• Funds pilot type interactions
• Scientific consultations (medical model)
• Pilot assays
• Statistical/informatics imput
• Study design assistance
• Vouchers
• Small web based request and approval
• Medium Administrative review
• Large GCRC Advisory Comm (GAC)
• Automatic tracking of funds provided, completion,
  value.

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Structure for Support of Study Development
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Grassroots Clinical ResearchA case study
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• Building a strong clinical trials program
• - creates a national reputation that attracts
  patients
• - allows us to compete as a center for the study
  of various patient populations for large NIH
  trials

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Interstitial Pulmonary Fibrosis Program

• Created by James Loyd
• Directed by Lisa Lancaster
• Evaluates patients for
• Healthcare options
• Clinical trials
• Lung transplantation
• Large referral base
• Closest IPF centers a distance away Duke,
  Emory, UAB, U. Colorado

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Growth of IPF Research Center
In 2006 became part Of the NIH IPF
Clinical Trials Network
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Vanderbilt DNA Databank
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Genomics In Full Force

• Senator Bill Frist (1/05, NEJM)
• in the next decade, the practice of medicine
  will change dramatically through genetically
  based diagnostic tests and personalized, targeted
  pharmacologic treatments
• Francis Collins (2/05)
• Personalized Medicine How the Human Genome Era
  Will Usher in a Health Care Revolution

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Vanderbilt DNA Databank Background

• Uses left-over clinical samples to create a
  centralized, cost-efficient genetic research
  resource
• associate genetic information with disease
  susceptibility and variable drug responses across
  populations
• improve patient safety and reduce adverse drug
  reactions
• Patients have the option to opt-out of
  participation

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Most Vanderbilt Patients Support DNA Databank
projectLocal Survey Results

• General favorability apparent
• 80 think the project is very important
• 90 think the hospital should be able to use
  leftover blood for medical research if personal
  information is removed
• 4-5 Oppose this type of genetic research
• Scientific aims generate support
• Prefer direct notification methods but a fine
  line with IRB

Patient Survey To Assess Attitudes and Opinions
(N1,005)
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Distinct Attitudinal Groups (Among Respondents
Who Could Be Segmented)
Allow opt outs
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The Synthetic Derivative Medical Information
System
Identified Clinical data (1.3M records)
Replaced record numbers Random social security
numbers Shifted birthdates, adm dates,
etc Substituted names
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Comparison to the worlds largest existing DNA
bank
Iceland database 125,000 records Genealogy
Homogenous population Paper medical
records Commercialized
Vanderbilt database 300,000 planned records
No genealogy Heterogeneous population
Electronic medical records Academic/shared
genotypes out of 1.5 million possible
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What Could Be Done?
Short term
Long term
Confirmation of role of known polymorphisms in
causing disease
Hypothesis Generation Rapid assessment of areas
suitable for further study
Discovery of new meaningful SNPs, haplotypes,
targets/pathways
Prediction Development of statistical models for
decision making
Healthcare Paradigm Shift Personalized medicine

• Focus on common, but genetically complex
  diseases
• Cancer, heart disease, diabetes, Alzheimers,
  macular
• degeneration, arthritis, Parkinsons,
  hypertension.
• As well as the dugs used widely to treat those
  diseases

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Personalized Medicine
September 5th, 2005
Doctors might be able to screen patients DNA
and predict not only whether they are likely to
have a heart attack but which type of heart
disease to expect and which drug or procedure
might work.
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Artists conception of the Vanderbilt Institute
for Clinical and Translational Research (VICTR)
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