Public-Private Sector Collaboration for Improving Population Health: Sharing Tools for Research
Ken Buetow, Ph.D. Associate Director, Bioinformatics and IT
National Cancer InstituteHealth IT Summit for Government Leaders
February 3, 2010
21st Century Biomedical Paradigm
• Personalized, 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
• Reporting of serious/fatal ADRs
• Re-labeling (or recall) as needed
• Additional indications as warranted
• Candidate selection and Optimization
• Pre-clinical testing
• Phase I, II, III
• New Drug application and Approval
• Product launch
• Clinical adoption
• Biological pathways
• Target identification and validation
DiscoveryDiscovery ProductProductDevelopmentDevelopment
Outcomes &Outcomes &SurveillanceSurveillanceClinical CareClinical Care
But We Still Operate in a 20th Century Research > Care Paradigm
Issues:• Ph IV not conducted uniformly
or consistently• Efficacy and ADR patterns are
recognized very slowly• New indications are gained
painstakingly from regulators• Recalls are financially
disasterous
Issues:• Linear, sequential
process• Information is trapped in
silos• Each trial demands re-
creation of infrastructure• No economies of scale• Failed candidates hard to
resucitate
Issues:• Launches and product
detailing are costly• Adoption can be slow• Traditional physician
outreach methods now constrained
• Process is slow and uni- directional
Issues:It’s difficult to:• Access clinical
outcomes data on relevant populations
• Access biospecimens of high quality with clinical data
• Validate in silico
DiscoveryDiscovery ProductProductDevelopmentDevelopment
Outcomes &Outcomes &SurveillanceSurveillanceClinical CareClinical Care
But We Still Operate in a 20th Century Research > Care Paradigm
Information on clinical experience with products is not captured systematically. Observations are “locked away” or ignored, and little new
knowledge is gained or leveraged.
ProductProductDevelopmentDevelopment
Outcomes &Outcomes &SurveillanceSurveillance
Clinical Clinical CareCare
Analysis and Analysis and LearningLearning
DiscoveryDiscovery
21th Century Biomedical Paradigm: a Learning Health System
Biomedical Knowledge Cloud
Consumer
CommunityHospital
ResearchHospital Research
Institution
ComparativeEffectiveness
Quality
Pharmaco- Vigilance
Industry
DecisionSupport
DataAggregators
AnalyticsBiomedicalResearch
Bio- Surveillance
Practice
Biomedicine Can Be An Interconnected Ecosystem
IT-enabled Connectivity
The cancer Biomedical Informatics Grid® (caBIG®) is a virtual network 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®: Biomedical Information Highway
Clinical Research
PathologyMolecular Biology
Imaging
Molecular MedicineMolecular Medicine
caBIG® Capabilities Enable Discovery > Translation > Clinical Research
Clinical Research
PathologyMolecular Biology
Imaging
• Track clinical trial registrations
• Facilitate automatic capture of clinical laboratory data
• Manage reports describing adverse events during clinical trials
• Combine proteomics, gene expression, and other basic research data
• Submit and annotate microarray data
• Integrate microarray data from multiple manufacturers and permit analysis and visualization of data
• Utilize the National Cancer Imaging Archive repository for medical images including CAT scans and MRIs
• Visualize images using DICOM-compliant tools
• Annotated Images with distributed tools
• Access a library of well characterized, clinically annotated biospecimens
• Use tools to keep an inventory of a user’s own samples
• Track the storage, distribution, and quality assurance of specimens
Molecular MedicineMolecular Medicine
caBIG® Capabilities Enable Discovery > Translation > Clinical Research
Clinical Research
PathologyDiscovery Research
Imaging
Clinical CareClinical Care
caBIG® Capabilities Enable Discovery > Clinical Research > Clinical Care
Oncology- Extended Electronic Health Record: A collaborative national effort
Oncology- Extended Electronic Health Record: A collaborative national effort
• American Society of Clinical Oncologists (ASCO)• Began evaluating issue, involving end users• Engaged the vendor community EHR lab (30), utilizing
unique case scenarios• High level requirements document/white paper outlining
the issue• cancer Biomedical Informatics Grid (caBIG®)
• Vendor technology evaluation• Problem assessment• Technical Specification
• NCI Community Cancer Center Program (NCCCP)• Oncology EHR Laboratory
• 30+ EHR vendors
Research Unit
IT-enabled ecosystem
Imaging
Biospecimen Data
Clinical Data
Molecular Data
Research Center
Security Advertisement / Discovery
Federated QueryWorkflow
Metadata Management
Dorian GTS Index Service
Federated Query
Service
Workflow Management
Service
Vocabularies & Ontologies
GME Schema Management
Common Data Elements
Medical Center
Research Center
Research Center
Medical Center
Medical Center
Medical Unit
Research Center
Research Center
Security Advertisement / Discovery
Federated QueryWorkflow
Metadata Management
Dorian GTS Index Service
Federated Query
Service
Workflow Management
Service
Vocabularies & Ontologies
GME Schema Management
Common Data Elements
Research Unit
Research Center
Medical Center
Research Center
Research Center
Medical Center
Medical Center
Medical Unit
Research Center
Research Center
Biomedical Knowledge CloudGrid Services Infrastructure
IT-enabled ecosystem
Security Advertisement / Discovery
Federated QueryWorkflow
Metadata Management
Dorian GTS Index Service
Federated Query
Service
Workflow Management
Service
Vocabularies & Ontologies
GME Schema Management
Common Data Elements
Research Unit
Research Center
Medical Center
Research Center
Research Center
Medical Center
Medical Center
Medical Unit
Research Center
Research Center
Biomedical Knowledge CloudGrid Services Infrastructure
Biomedical Knowledge CloudGrid Services Infrastructure
IT-enabled ecosystem
caBIG® is Linking the Cancer Community
caBIG® Works through International Collaborations
caBIG®, the world’s largest biomedical research “highway”, connects a growing number of individuals and organizations across the globe
United States, Mexico, Chile, Uruguay, Argentina, Brazil, UK, The Netherlands, Germany, Czech Republic, Finland, Jordan, India, China, New Zealand
Pioneering a 21st Century Biomedical Ecosystem:
The BIG Health Consortium™
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.
Vision:A biomedical system that synergizes the capabilities of the entire community
to realize the promise of personalized medicine
The Ecosystem Has Multiple Constituencies
GovernmentGovernment
ResearchersResearchers
Clinical Communities
Discovery ScienceInformation Technology
Underwriters/Payors
Care Deliverers
Care Deliverers
Consumers/ Patients
Consumers/ Patients
FoundationsFoundations
Payers / Insurance
Companies
Payers / Insurance
Companies
IndustryIndustry
AcademiaAcademiaResearch
Infrastructure Research
Infrastructure Electronic
Health Records Electronic
Health Records
21st Century Biomedical Ecosystem
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 Records EHRs can connect to clinical trials in hospital settings
Research Finding Knowledgebases Large-scale databases of latest research findings are connected to health delivery encounter
Learning Healthcare System Local and national clinical encounter information is fed back to care providers to help inform clinical decision making
21st Century Biomedical Ecosystem
Consumer
My Genomic Profile Consumers get their genetic and predisposition risk information
My Prevention Strategies Consumers work with genetic counselors; coordinate with health care provider
My Clinical Record Consumers link to their clinical histories with geneticprofiles; access clinical research; participate in volunteer networks
21st Century Biomedical Ecosystem
Standards
Interoperability
Data Sharing
Connectivity
21st Century Biomedical Ecosystem
The Ecosystem in Action: BIG Health Projects
Lance Armstrong Foundation: Adolescent and Young Adult Biorepository
Objectives
• Build an infrastructure to support biospecimen collection, storage, and sharing among academic sites
• Address patient privacy and intellectual property issues• Integrate into a centralized portal
Adolescent and Young Adult Oncology Biorepository: Federated Network
Vanderbilt University Nashville, TN.
Oregon Health and Science UniversityPortland, OR.
Indiana University School of Medicine, Indianapolis, IN.
Kaiser Foundation HospitalsPortland, OR.
Nationwide Children’s Hospital, Columbus, OH.
LIVESTRONG, Austin.TX.
MD AndersonHouston, TX.
BIG Health Network
Athena Breast Cancer Network
Athena Breast Cancer Network
• The Athena Breast Health Network will integrate clinical care and research to drive innovation in prevention, screening, treatment and management of breast cancer
• This project will improve survival and reduce suffering from breast cancer by accelerating research discovery and the time it takes to implement innovations in clinical practice
• 5 hospitals (total of 13 sites in San Francisco, San Diego, Davis, Los Angeles, Irvine) will work together fueled by financial resources from outside the university system
• Will encompass 400,000 women
Athena IT Infrastructure
Proteomics DataExpression Array DataSNPArray Data Radiological DataClinical DataPatient Samples
Data Warehouse
Data WarehouseAPI Hosted
SystemsHosted
SystemsCTODS
caExchange - Hub
Tolven CTMS Suite
APIGrid-EnabledcaBIG® ApplicationsGrid-EnabledcaBIG® Applications
caTissue
caArray
Cancer Genome Workbench
API
caGWAS CPAS
caGRID
Consumer-centric research: the Love Army of Women
BIG Health is partnering with the Love/Avon Army of Women to build a consumer-owned online
cohort of one million women
Health of Women Study
• Members of Army of Women are invited to join the Health of Women study and respond to periodic secure online questionnaires concerning health history
• Authorized researchers access data and design study protocols based on clinical profiles and data of potential research participants
• Database enables “interactive” and “dynamic” process – as researchers conceive new projects and women add more health information, new theories can be generated and additional opportunities for participation arise
• Researchers propose to the consumers studies that they would like to conduct. Woman decide, on-line which studies in which they want to participate. Any additional information collected as part of the study is electronically “connected” back to the Army
Research Study
Army of Women “Ecosystem”
Research Study
Health of Women Cohort
Research Study
Research Study
Research Study
Research Study
Research Study
Research Study
Research Study
Research Study
www.bighealthconsortium.org http://cabig.cancer.gov
For more information, contact: [email protected]