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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Bio Reposito

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Bio Reposito

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Motivations

CER,CER,PCOR,PCOR,P4P,P4P,HSRHSR

Bio Repositor

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Bio Repositor

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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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