Transcript Slide 1

IndianaCTSI
ACCELERATING CLINICAL AND
TRANSLATIONAL RESEARCH
Building an Indiana
Biorepository
Dave A Flockhart
Eric Meslin
April 19th, 2010
IndianaCTSI
ACCELERATING CLINICAL AND
TRANSLATIONAL RESEARCH
Support
$6 million from the Lilly Foundation
$2 million to build an Informatics Portal
IndianaCTSI
ACCELERATING CLINICAL AND
TRANSLATIONAL RESEARCH
Biobanks in Context
• Biobanks are collections of samples linked
with other valuable information
• Biobanks can take many forms, i.e. blood,
plasma, serum, urine, tumor tissues, etc.
• Biobanks can be as small as less than a
hundred samples or can be as large as
hundreds of thousands
IndianaCTSI
ACCELERATING CLINICAL AND
TRANSLATIONAL RESEARCH
Examples of large Biobank linked to EMRs
– Marshfield Clinic: Marshfield, WI; N=18000 (Wisconsin
residents)
– UK Biobank: United Kingdom; N=500,000 ages 40-60yo;
collects DNA, serum, plasma and urine linked to medical records
and lifestyle questionnaires
– Biobank Japan: Kanagawa, Japan; N=300,000; DNA samples
from individuals of 20+
– BioVU: Vanderbilt’s DNA Bank; N=75,000+; DNA samples
linked to eMR
– RPGEH: Kaiser Permanente Research Program on Genes,
Environment, and Health; N=500,000; the completed resource
will link together comprehensive electronic medical records, data
on relevant behavioral and environmental factors with the DNA
obtained from blood or saliva
IndianaCTSI
ACCELERATING CLINICAL AND
TRANSLATIONAL RESEARCH
Technical Requirements
• Comprehensive Governance Structure
• Robotic Access and Retrieval
• Fast and Effective Access to Preliminary Data
• Fast and Effective Access to Samples
• User-Friendly Outcomes Data
IndianaCTSI
ACCELERATING CLINICAL AND
TRANSLATIONAL RESEARCH
Principles for the Indiana Biobank
• Catalytic for all Indiana Researchers
• User-friendly Informatics and Access
• Regulatory compliant and ethically sound
• A sample repository linked to validated data,
including medication data
• Clear, robust SOPs for collection, storage
and sharing.
IndianaCTSI
ACCELERATING CLINICAL AND
TRANSLATIONAL RESEARCH
Biobank Governance Issues
– Consent policies and procedures
• Opt-in, opt-out
– Public engagement strategies
• Building, maintaining trust
• Benefit-sharing
– Privacy/confidentiality assurances
• Balancing protection and discovery
– Data/sample sharing SOPs
– Commercialization, IP, tech transfer
– Harmonization challenges (esp. international)
IndianaCTSI
ACCELERATING CLINICAL AND
TRANSLATIONAL RESEARCH
Privacy and the Need to Identify
Source: Altman, (2005)
IndianaCTSI
ACCELERATING CLINICAL AND
TRANSLATIONAL RESEARCH
Commercialization
• Human body has financial value
 Tissue samples for research, esp.
with rare diseases; health data linked
to unique phenotypes
• Product development
 Pharmacogenomics drugs
 Tailored therapeutics
 Device development
• Varying resistance to the role of
industry
 The Moore objection
 Commodification as a moral wrong
 Source of sponsorship
IndianaCTSI
ACCELERATING CLINICAL AND
TRANSLATIONAL RESEARCH
Public Willingness to Participate in Biobanks
IndianaCTSI
ACCELERATING CLINICAL AND
TRANSLATIONAL RESEARCH
Informed Consent: What Do We Know?
IU Cancer Patients
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•
~85% agreed that stored tissue could be used in
unspecified future research
60-70% would not require re-contact each time
tissues were used
–
Helft , Champion, Eckles, Johnson, Meslin, (2007)
Women and Pregnant Mothers
•
•
77% felt predictive health research was
worthwhile
Most supported consent for future use
–
Haas, Renbarger, Meslin, Drabiak, Flockhart (2008)
Parental Attitudes-—Pediatric Biobanking
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•
•
•
68% agree/strongly agree pts should have
chance to be in research
81% somewhat/very likely to permit child’s blood
to in biobank
91% have fair/great deal of trust in hospitals to
protect confidentiality
62% oppose/strongly oppose commercialization

Harland, Miller, Meslin, Wolf, Denne (2010)
Physicians and Nurses—Pediatric Biobanking
•
•
MD and RN attitudes toward pediatric biobanks
are similar
Broad support for a pediatric biobank from
HCP, including support for unspecified use of
samples
–
Denne, Wolf , Meslin et al (2008) [Unpublished]
IndianaCTSI
ACCELERATING CLINICAL AND
TRANSLATIONAL RESEARCH
•
Administrative databases which collect: birth
“When people in the general community were asked
records, midwives' notifications, cancer
if they approved
of their inpatient
information
being
used ininregistrations,
hospital
morbidity,
this way, they
wereand
found
to out-patient,
be not onlymental
supportive
patient
public
health
of it, but theyservices
questioned
whydeath
it was
not already
data and
records
being done.”
•
Used in combination with medical record
audits to provide a comprehensive evaluation
and Meslin (2007)
of health Source:
systemStanley
performance.
IndianaCTSI
ACCELERATING CLINICAL AND
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The Future
• New Diagnostic Tests
• Biomarkers of Therapeutic Response
• New Targeted Therapies