cfar clinical and translational core
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CFAR Clinical and Translational Core. Partnership and Collaboration Vision for our Future Dr. Kathy Anastos. Big(gest) picture—Einstein/Montefiore Where we sit in big picture Details of each component What we need to accomplish by May Timeline. - PowerPoint PPT PresentationTRANSCRIPT
CFAR Clinical and Translational Core
Partnership and CollaborationVision for our FutureDr. Kathy Anastos
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• Big(gest) picture—Einstein/Montefiore
• Where we sit in big picture• Details of each component• What we need to accomplish by May• Timeline
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Keeping our eyes on the Prize
All biomedical research has as its ultimate goal
improving the public’s healthEspecially if funded with
public money
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Informatics
Informatics
Data collection Data management
Data integration,Contextualization
Analytics
IT Infrastructure (Network, Storage, Computational Cycles, Security)
Einstein Research Informatics
Universal ConsentFor biorepositing of “remainders”
Why Informatics?• Healthcare environment (research, practice,
operations)– Increasingly information intensive– Rapidly growing and competitive– Robust informatics and analytic infrastructure
critical
• The winners will be those using health information processing technologies in more creative and innovative ways
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Guiding Principles
Precision Medicine:-Personalized Medicine-Clinical Genomics-Epigenomics-Behavioral and Environmental
Precision Medicine:-Personalized Medicine-Clinical Genomics-Epigenomics-Behavioral and Environmental
Learning Healthcare System:-Evidence based-Continuous improvement -Patient Centered-Outcome driven
Learning Healthcare System:-Evidence based-Continuous improvement -Patient Centered-Outcome driven
Basic Science
Clinical ResearchHealth Services Research
Biospecimens
Clinical Practice
slide idea inspired by Eric Newmann: Translational Medicine from SW Perspective, June 2006Parsa Mirhaji
Transformational Informatics
Platform
Transformational Informatics
Platform
slide idea inspired by Eric Newmann: Translational Medicine from SW Perspective, June 2006
Research Practice
Parsa Mirhaji
Parsa Mirhaji
Comparative Effectiveness Research
Translational Research
Risk Assessment
Fraud Detection
Decision SupportMobile Health
Public Health
Data mining, business intelligence
Personalized Medicine
Integrated Perspective
Secondary UseSecondary Use
Genomics
Proteomics
Biomarkers
Clinical Trials
Prospective Studies
Comparative Effectiveness Study
Personalized Medicine
Guidelines &Best Practices
Rare Diseases
Patient Safety,Clinical Error
Decision Support
Meaningful Use
Quality & OutcomesResearch
Patient Empowerment
P4PHealth Economy
Multi-institutional Collaborative Research
Population Health
Drug Discovery
E/MResearch Informatics
E/MResearch Informatics
Basic ScienceBasic Science Clinical Research
Clinical Research
Clinical Practice
Clinical Practice OperationsOperations
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Hea
lth
Eco
nom
y
Bio Reposito
ry
Bio Reposito
ry
Motivations
CER,CER,PCOR,PCOR,P4P,P4P,HSRHSR
Bio Repositor
y
Bio Repositor
y
Health Economy/Finance
Health Economy/Finance
Community, Environment (Bronx, NY)
Community, Environment (Bronx, NY)
ACORHIO
(Bronx, NY)RHIO
(Bronx, NY)
Value Of This Infrastructure to CFAR-Both Actual and Perceived
• Extant large resource• Montefiore’s strengths become our strengths:
community focus, integrated system of care, large investment in IT; leader in IT and CQM/CQI
• Grounds us in a large and stable infrastructure• We can be integrated into each component • Brings us control groups, not only in data, but also
with tissue and specimens• Creates perception (and reality) of an integrated
system
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First box—Electronic Health Records
• Montefiore’s full clinical set of clinical records
• Can identify those HIV+, known HIV-negative, and unknown HIV serostatus
• Creates enormous power epidemiologically, and ability to define control groups
• Challenges: clinical data is “dirty” and incomplete
• How to define the HIV+ population for our data warehouse?
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Clinical Populations• Center for Positive Living (ID Clinic) 2980• CICERO (MMG2, community based) 856 • MMG 1 (MAP) ~250• Private practices (MAP) ~450• Division of Substance Abuse (DOSA, 3500) ~700• Adolescents• Gynecologic practices • HIV+ pregnant women 85
– Montefiore and Bronx Lebanon• Pediatric pre-adolescents• HIV-exposed, uninfected children
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Figure 1. Viral Load by CD4 by ARV Medication. Clicking on any number in this table will drill down further and list the cohort with more explicit clinical information
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Figure 2. Medication Prescription Year by Discontinuation Year. Clicking on any category of Medication will further drilldown to specific medication (Figure 3).
Current Research Infrastructure
• Center for Positive Living– 5 study coordinators– Separate space contiguous to the clinic– Have completed 31 trials, with ~2300
participants– Currently have 16 active studies, 400
participants– Able to recruit rapidly for
• translational studies• Behavioral studies• Clinical studies including RCT
– Can enroll participants from other sites25
Current Research Infrastructure
Division of General Internal Medicine• Extensive junior investigator development
with multiple K awards• Bring an unusual strength in substance
use• Extensive research in substance use and
HIV– 4 R01s (Arnsten, Cunningham, Litwin)– K23 (Litwin)– R03 (Litwin)– CFAR pilot study (Nahvi)
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Tasks and TimelineClinical Programs
• Create the “join” for the clinical (EHR) database (who are the patients, what are the variables)—Late January
• Create program to “pull” the data into a central data warehouse—mid to late February
• Develop/expand clinical research groups-January • Consider subgroups of CAB--February• Perform at least two translational studies NOW• Ramp up enrollment into biorepository from clinical
populations—begin by late January 27
How to Expand Biorepository
• Expand clinical sites from which can recruit
• Expand clinical criteria for enrollment• Expand collection sites: at which
enrollment process can occur• Expand types of specimen collected• Overcome other barriers—e.g. restriction
on number of enrollees per day for specimen processing
• This MUST happen— rapid enrollment28
Research Programs (with and without biorepositories)
• Women’s Interagency HIV Study (WIHS)• Rwanda Women’s HIV Study (RWISA)• Herold lab’s studies (20 studies, a few
hundred patients)• Mark Einstein’s clinical trials/studies• Laurie Bauman’s behavioral studies• Other international populations• These represent not only patients and
specimens, but also INFRASTRUCTURE29
Some WIHS Specifics• WIHS HPV studies, molecular epidemiology: Howard
Strickler and Robbie Burk• WIHS cardiovascular studies: Robert Kaplan• WIHS neurocog studies: led by Chicago WIHS• WIHS body composition and bone studies—led by
Bronx WIHS • Extensive established collaborations with other
institutions• Local and National specimen repositories: 3 million
aliquots: serum, plasma, PBMC, cell pellets, DNA, CVL, vaginal and cervical swabs, urine, saliva, some tissue
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Tasks and Timeline—Research Programs with
Biorepositories• Identify all existing databases• Researchers provide information on
variables and data structure to data team
• Prioritize inclusion• Consolidate the research databases
from all sources • Perform at least two translational
studies NOW31
Performing Translational Studies
• Requires a COLLABORATION• In other words, the Clinical Core
alone cannot create the translational studies
• Bench scientists must start using human specimens
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So, Concretely, by May
• Develop data warehouse from EHRs, and perform at least one epi study
• Develop the research data warehouse linked to biorepositories, and perform at least two translational studies
• Develop stronger institution-wide ties to DOSA
• Rapidly enroll into the clinical services biorepository and perform a translational study
• Repackage our strengths33
Team(s)• Kathy Anastos—Director of CTIC• Co-Directors:
– Julia Arnsten: Clinical and Epidemiologic– Betsy Herold: Translational
• Others– Barry Zingman—CPL, integrated research
infrastructure– Chinazo Cunningham—community focused
research– Data team: Mindy Ginsberg, Marty Packer, Alex
Peshansky, (Parsa, Eran)– Others TJ 34
When our minds can conceive it
And our hearts can perceive itThen our hands can achieve it
i.e. We can Succeed
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