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TRANSCRIPT
October 2008
“BIG Health: A 21st Century Biomedical System
demonstrating Personalized Medicine
Ken Buetow
National Cancer Institute
Outline
I. Overview
II. caBIG™
III. BIG-Health™
V. Opportunities
• Goals
• Participants
• Activities
• Challenges
Personalized Medicine:
What We’re Trying to Achieve
• Predictive, Preemptive,
Participatory……
• Unifies clinical research, clinical
care, and discovery (bench-
bedside-bed) into a seamless
continuum
• Results in improved clinical
outcomes
• Accelerates the time from
discovery to patient benefit
• Enables a health care system,
not a disparate “sector”
• Empowers consumers in
managing their health over a
lifetime
“The world we have created today has
problems which cannot be solved by
thinking the way we thought when we
created them.”
- Albert Einstein
Challenges:
The Biomedical Landscape
• Isolated information “islands”
• Information dissemination
uses models recognizable to
Gutenberg
• Pioneered by
London Academy of Science
in the 17th century
• Write manuscripts
• “Publish”
• Exchange information at
meetings
New Model: Link
Discovery > Clinical Research > Clinical Care
The Concept: Connect scientific discovery, clinical research and
clinical care into a seamless continuum that continually builds and
applies knowledge
Pediatric cancer is a successful example of this approach
• Faster, more efficient patient
recruitment for trials
• Improved clinical trials
outcomes due to improved
patient selection
• Faster adoption by the health
care delivery system
• Reduced infrastructure costs
The opportunity for health
care providers:The opportunity for research:
• A pathway to innovation
• A chance for physicians
outside academic medical
centers to participate in clinical
research
• Additional resource source
• A strategy to address clinical
care challenges to improve
outcomes
New Model: Link
Discovery > Clinical Research > Clinical Care
Tremendous improvement in childhood cancer survival since 1975
• Overall reduction of cancer mortality by 50%
• acute lymphoblastic leukemia survival rate has improved from 5% in the 1960’s to more than 85%
• Molecular characterization used to determine treatment
Childhood cancer is treated in a context that blends care delivery and clinical research
• Researchers and practitioners are able to correlate experimental laboratory data with clinical data (treatment, history, pathology, outcome, etc.)
• Clinical data are utilized to continuously evaluate outcomes
• Researchers develop and refine evidence-based strategies at an individualized level
• Care providers improve quality by adherence to care standards
Information flow is critical…
this model cannot be achieved without IT connectivity
Outline: Background on caBIG™
I. Overview
III. BIG-Health™
V. Opportunities
• Goals
• Participants
• Activities
• Challenges
II. caBIG™
The caBIG® Initiative
caBIG® is an a virtual web of interconnected data, individuals, and organizations that redefines how research is conducted, care is provided, and patients/participants interact with the biomedical research enterprise.
caBIG® Vision
• Connect the cancer research community through a shareable,
interoperable infrastructure
• Deploy and extend standard rules and a common language to more
easily share information
• Build or adapt tools for collecting, analyzing, integrating and
disseminating information associated with cancer research and care
Current silos are disconnected and can’t communicate
Current Healthcare Infrastructure
Healthcare
Delivery /
Patient Care
Clinical
Research
Environment
Regulatory
Reporting
Environment
Next Generation Infrastructure
HL7v2.x
BRIDG
(HL7 v3)
BRIDG
(HL7v3,
CDISC)
Healthcare
Delivery /
Patient Care
Clinical
Research
Environment
Regulatory
Reporting
Environment
Standards allow information to be exchanged
Next Generation Infrastructure
HL7v2.x
BRIDG
(HL7 v3)
BRIDG
(HL7v3,
CDISC)
Healthcare
Delivery /
Patient Care
Clinical
Research
Environment
Regulatory
Reporting
Environment
caXchange
Patient Registration & Enrollment
Capture of Clinical Lab Data
Scheduling of Treatment
Capture of Adverse Effects
Research
Data
Warehouse
Investigator
Registry,
Results
(Janus)
Outcomes
Warehouse
caMATCH
PHR
Tools provide functionality to
enable a seamless continuum.
Policy: Analysis Framework
ALL of the following:
- no IP value
- low sensitivity data
- no IRB restrictions
- no sponsor restrictions
ANY of the following:
- moderate IP value
- moderate sensitivity data (e.g., LDS)
- limited institutional or IRB policy
restrictions
- moderate sponsor restrictions
ANY of the following:
- high IP value
- high sensitivity data (e.g., PHI)
- significant IRB/consent restrictions
- major sponsor restrictions
“EZ Pass” - General Website Terms of
Use
Standardized Click-Through
Terms and ConditionsBi-Lateral or Multi-Lateral MTA
Data/Specimens
Data Sensitivity(Regulatory Status)
IP Value(Need for Protection)
IRB/ Institutional Restrictions(Policy/ Consent Limitations) Sponsor Restrictions
(Contract Terms & Conditions)
High
Medium
None/Low
Identifiable Data
Coded/Limited Data
Set
De-Identified/
Anonymized Data Set
Explicit Consent
Limitations or
Restrictions
Policy Limitations
Generic Registry or
caGRID Permission
Classified Research/
Major Restrictions
Delays or Other
Moderate Restrictions
No Restrictions
Examples: is the data subject to a restrictive
license? Is it related to an invention report
you have or intend to file with your institution?
Do federal or state law or your institution's
policies prohibit or restrict disclosure?
Do your Institution's or IRB's policies or the applicable
informed consent documents explicitly or implicitly
restrict or permit disclosure (e.g., “no commercial use”)?
Do terms and conditions in any sponsored
agreements prohibit or restrict disclosure
outside institution or to caGRID?
Decision Tree for Privacy/Intellectual Capital Terms and Conditions
Connected with caBIG®
• caBIG® adoption is unfolding in:
• 56 NCI-designated Cancer Centers
• 16 NCI Community Cancer Centers
• caBIG® being integrated into federal health architecture to connect National Health Information Network
• Global Expansion• United Kingdom
• China
• India
• Latin America
NCI-Designated Cancer Centers,
Community Cancer Centers, and
Community Oncology Programs
Local Authenticator
NCI GTS
Local Authenticator
Local Authenticator
Local Authenticator
NCI Dorian
Local Credential
Local Credential
Local Credential
Local Credential
Grid CredentialsGrid Grouper
NodeNode Node Node
NCI caDSR Service NCI Index Service NCI GME
caGrid
Local Authenticator
NCRI GTS
Local Authenticator
Local Authenticator
Local Authenticator
NCRI Dorian
Local Credential
Local Credential
Local Credential
Local Credential
Grid CredentialsGrid Grouper
NodeNode Node Node
NCRI caDSR Service NCRI Index Service NCRI GME
NCRI ONIX
Local Authenticator
NIH GTS
Local Authenticator
Local Authenticator
Local Authenticator
NIH Dorian
Local Credential
Local Credential
Local Credential
Local Credential
Grid CredentialsNIH Grid Grouper
NodeNode Node Node
NIH caDSR Service NIH Index Service NIH GME
NHLBI Grid (CVRG)
Bilateral
Negotiations
Grid of Grids…
Outline: BIG-Health™
I. Overview
II. caBIG™
V. Opportunities
III. BIG-Health™• Goals
• Participants
• Activities
• Challenges
BIG Health Consortium™
Mission:
The BIG Health Consortium™ is a collaboration among stakeholders in biomedicine,
including government, academe, industry, non-profit, and consumers, who come
together in a novel organizational framework to demonstrate the feasibility and
benefits of the personalized medicine paradigm.
Strategy:
Through a series of personalized medicine demonstration projects, with an
expanding number of collaborators, BIG Health will bootstrap a new approach in
which clinical care, clinical research, and scientific discovery are linked.
Vision:
A biomedical system that synergizes the capabilities of the entire community
to realize the promise of personalized medicine
Government
Personalized Medicine Requires Participation
of Multiple Members of a Complex Ecosystem
Researchers
Clinical Communities
Discovery ScienceInformation Technology
Payers
CareDeliverers
Consumers
Foundations
Payers / Insurance
Companies
GenomicistsProteomicists
Systems Biologists
Research Infrastructure
Electronic Health Records
Research
Participants
Patients join research networks, grant consent, agree to be “sought” and to enroll – “on-demand” participants
Biospecimen Collections
Researchers can access and query large collections of well-characterized, clinically annotated specimens
Discovery of Correlations
Biomarkers are identified and validated; disease sub-groups emerge
Individualization of Treatment
Patients are identified by sub-groups and treated appropriately
Clinical
Practice
Electronic Health RecordsEHRs can connect to clinical trials and
hospital settings
Outcomes InformationLarge-scale databases of outcomes can be queried
Patient ParticipationPatients can access clinical trials, educational
materials, etc.
Consumer
My Genomic ProfileConsumers get their genetic and predisposition
risk information
My Prevention StrategiesConsumers work with genetic counselors;
coordinate with health care provider
My Clinical RecordConsumers link to their clinical histories with genetic
profiles; access clinical research; participate in
volunteer networks
Outline: Process for Implementation
I. Overview
II. caBIG™
III. BIG-Health™
• Goals
• Participants
• Activities
• Challenges
V. Opportunities
BIG-Health™ Consortium Next Steps
• Convened Roundtable Workshop on September 10
• Determining organizational and communications structure
• Developing Pilot Projects working plans, timelines, etc.
BIG Approaches to Big Challenges
in Personalized Medicine
Possibilities for Demonstration Projects
• Virtual clinical research
• On-demand clinical trial
• 21st century cohort study
• Molecularly-based comparative effectiveness
• Learning health care system
• Monitor outcomes
• Monitor incidence
• Post marketing surveillance
• Rapidly disseminate