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Clinical Research Informatics
William G. Adams, MDAssociate Professor of Pediatrics
Director, BU-CTSI Clinical Research Informatics
November 10, 2009
Visibility of Translational Research
• CTSA program• By 2012, 60 programs at a cost of
$500 million per year• Foundations• Industry• Disease-related organizations• Hospitals and health systems• Journals
What is “translational research”?
T1 and T2
• T1: “The transfer of new understandings of disease mechanisms gained in the laboratory into the development of new methods for diagnosis, therapy, and prevention and their first testing in humans.”
• T2: “The translation of results from clinical
studies into everyday clinical practice and health decision making.”
Sung, N. S. et al. JAMA 2003;289:1278-1287.
Copyright restrictions may apply.
Sung, N. S. et al. JAMA 2003;289:1278-1287.
IOM Clinical Research Roundtable
Central Translational Challenges
1. Public Participation2. Information Systems3. Workforce Training4. Funding
Sung, N. S. et al. JAMA 2003;289:1278-1287.
The Laboratory of T1
Resources Needed for T1
• Mastery of molecular biology, genetics, and other basic sciences
• Appropriately trained clinical scientists
• Strong laboratories
• Cutting-edge technology
• Supportive infrastructure within the institution
The Laboratory of T2
Resources Needed for T2
“Implementation science”: evaluating interventions in real-world settings
• Clinical epidemiology and evidence synthesis• Communication theory• Behavioral science• Public policy• Financing• Organizational theory• System redesign• Informatics• Mixed methods/qualitative research
Informatics Resources Across the Research Continuum
Hypothesis generation, cohort preparation (intra- and inter-institutional), epidemiology
IRB protocol preparation and approval
Subject Recruitment
Research Data Management
Research Task Informatics Resource
BMC-CDWi2b2*CliniWorks
Consultation Service
INSPIR
Volunteer* Registry
Red-Cap*
BMC-CDW
* Open-source software available from CTSA community
Research Networking Profiles*
CRI Systems and Projects
• Data Repositories (i2b2)• BU-i2b2• Massachusetts Health Disparities Repository
(MHDR)• Shared Research Information Network
(SHRINE)• Subject Registries (ResearchMatch.org)• Research Data Capture (RedCap)• Research Networking (Profiles)
What is i2b2?
• “Informatics for Integrating Biology with the Bedside”
• Open-source software based on the MGH Research Patient Data Repository (RPDR)
• Collection of modules or “cells” constitute the i2b2 “hive”• PHI-free clinical database repository• Self-service query and analysis tool
OntologiesAttribute Description Ontology Code System
Weight Body Weight (kgs) Clinical Obs 27113001 SNOMET-CT
Gender Gender Demographics
365873007
SNOMET-CT
cd4 count CD4 cell (# Bld) Lab Tests 8127-3 LOINC
Attribute ID Value Date
Weight 6 120 7/12/2009
Gender 6 M 9/12/2009
cd4 count 6 750 4/1/2009
Facts
Core Tables of the i2b2 Data Repository
i2b2 @BU
Two installations:• BU-i2b2
•Core BU-CTSI Resource•Installation to be completed next week
• MA-Health Disparities Repository (MHDR)•Kressin/Adams co-PIs•NIH Grand Opportunity (GO) Grant•Began in October 2009
Boston Medical Center
Community Health CentersHealthNet Plan
Boston-MHDR•Researchers have direct access to patient-level data within repository•IRB must approve creation of repository and (separately) all research protocols
BU-i2b2•Researchers only have access to repository via software that performs aggregate queries (counts > 5)•IRB must approve creation of repository•Queries are not human subjects research
Research Data System
Clinical Data SystemData Processing•Researchers do not have access to clinical data•CDW staff or “business associate” creates and transfers Limited Data Set via automated scripts•Secure, encrypted Link Table used for updates
Clinical Data (BMC Clinical, CHC Clinical, HealthNet Claims)
ETL (Extract, Transform, Load)
Limited Dataset(s)* in i2b2 format
Covered Entities
* Limited data set identifiers limited to registry ID and census tract for Boston-MHDR and registry ID for BU-i2b2
BUMC i2b2-related Research Repositories Overview
BU-i2b2
• Established using CTSA core resources
• Currently under evaluation as pilot tool• Actively looking for pilot evaluators• Expansion plan to include visits and
health insurance ontologies
Massachusetts Health Disparities Monitoring System
Nancy Kressin, PhD, Director, Health/care Disparities Research Program
William Adams, MD, Associate Professor of Pediatrics, and Director, Clinical Research
Informatics, BU-CTSI
Project Team
• Christopher Shanahan• Arlene Ash• Amresh Hanchate• Michael Paasche-Orlow• Emelia Benjamin• Joel Weissman (consultant from the
state)• UMass: Ralph Zottola, Jeroan Allison• Recombinant Data Corporation
Aims
1. Create infrastructure to monitor CVD risk factors and outcomes • large, longitudinal, statewide de-identified
database • new software tools for “push button”
monitoring, data extraction and geo-mapping
2. Explore the effects of health reform and the economic downturn on health disparities in Massachusetts
3. Develop strategies for sharing tools and communicating results to policy makers, health care providers, and the research community
Data Sources
• BMC (clinical data warehouse)• BMC affiliated community health
centers• BMC Health Plan (claims data)• UMass Medical Center (clinical
data warehouse)
Receives within minutes qualified results
EMR views dashboard is generated on-the-fly out of free text documents only!
Click on the found term will get you to the original document source
De-identified within text:
• Visit details, MRN
• Visit day + month
• Patient’s name
• Former Locations
• Providers names
ASSESSMENT: 52-year-old male with poorly-controlled, type 2 diabetes. He isprobably maxed out on oral agents. See above conversation. Other problemsinclude uncontrolled hypertension, mild persistent hyperlipidemia, now on amaximal dose of Lipitor.
PLAN: He is fasting, so check fasting lipids plus SGPT. Recheck hemoglobinA1c. Work on carb counting and get a diabetes update with our diabeteseducators and then transition him to Humalog. At that point, discontinueGlucotrol. Consider him for a pump candidate. Decide on an ARB. Follow upwith me in three or four months.
ADDENDUM: Triglycerides 54, HDL 37, and LDL 72. Potassium is 3.5,creatinine 1.0. HbA1c 8.8%, and urine microalbumin pending.
Dictated by:* ****************, M.D.Assistant Professor
Electronically Authenticated - XX/XX/08
LKC/mhm T *** D *** A XX/XX/08
i2b2.org
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i2b2 and Shared Health Research Information Networks (SHRINE)
Douglas MacFaddenAndrew McMurryShawn Murphy
Partners Healthcare
http://catalyst.harvard.edu
• Networks i2b2 clinical databases across the web
• Aggregates query results across all sites
• Each site maintains autonomous database
What does SHRINE do?
SHRINE
• 5.6M+ Patients• 890M+ Facts• 3 Ontology Categories, 18k+ Terms• 4 major competing hospitals, 3 sites• 7,500+ Potential Users• 4 IRBs
Metrics as of October 2009
• CTSAs• University of Washington• UC San Francisco• UC Davis
• IRB approved SHRINE deployments
West Coast SHRINE Sites
ResearchMatch.org
Paul Harris, PhDDirector, CTSA Biomedical Informatics Operations
Department of Biomedical Informatics, Vanderbilt University
What is ResearchMatch.org?
• A centralized, web-based recruitment registry designed to ‘match’ individuals interested in participating in research with research teams
• Institution-neutral; Disease-neutral; Study-neutral
• Complementary, no-cost recruitment tool for research teams
• CTSA collaboration - 38 participating CTSAs
How will ResearchMatch.org work?How will ResearchMatch.org work?
Step 1: Potential volunteers (or their parents/caretakers) self-register to indicate a willingness to be contacted for research studies.
Step 2: Registered researchers search database for individuals (identifiers suppressed) based on study inclusion criteria.
How will ResearchMatch.org work?How will ResearchMatch.org work?
Step 3: Researchers send approved recruitment message to ‘matched’ volunteers. Volunteers may then opt to share identifiable information for direct contact.
Step 4: Researchers contact interested volunteers and follow normal study consent procedures.
Research Electronic Data Capture(REDCap)
Paul Harris, PhDDirector, CTSA Biomedical Informatics Operations
Department of Biomedical Informatics, Vanderbilt University
REDCap Project Overview
2004 Needs AssessmentResearchers needed help managing data for small/medium sized non-trial research projects (pilot, R01, PPG)
HypothesisResearchers will do the right thing (secure, audit trails, etc) if provided an easy way to get needed tools
ProblemMany projects, few resources
REDCap Project Overview
Solution: Metadata-driven application (no per-project programming)
2004 - First REDCap project operational at VU
2006 - REDCap ConsortiumLaunched REDCap Consortium to share with other universities and foster collaboration for future development
2008 – CTSA Informatics Pilot Project (IPP) AwardIncrease capacity and streamline processes for collecting and managing data in diverse scientific areas of study
REDCap Survey
Currently @ 12 Institutions80,000 Surveys Collected
RedCap Features
• Secure• Researcher driven• Meta-data library • MySQL• Export flexibility• Inexpensive
Collaborating on “Profiles”A case study on sharing a research networking platform
& informatics across Harvard & UCSF
Maninder Kahlon, PhD (UCSF)CIO, UCSF CTSI
Griffin Weber, MD, PhD (Harvard)CTO, Harvard Medical School
Harvard Catalyst Profiles – Active & Passive Networking
Keyword Cloud CoAuthors: Map View CoAuthors: Radial Graph
SNA: Network Reach SNA: Closeness SNA: Keyword Network
A “Boston Common”?
• Discussions underway to potentially create:• BU-Profiles• Tufts-Profiles• Integrated system (The
Boston Common)
Informatics Resources Across the Research Continuum
Hypothesis generation, cohort preparation (intra- and inter-institutional), epidemiology
IRB protocol preparation and approval
Subject Recruitment
Research Data Management
Research Task Informatics Resource
BMC-CDWi2b2*Cliniworks
Consultation Service
INSPIR
Volunteer* Registry
Red-Cap*
BMC-CDW
* Open-source software available from CTSA community
Researcher Networking Profiles*
Concluding Thoughts
• Informatics essential component of Clinical/Translational Research
• Superb open-source opportunities from CTSA Community
• Small investments could lead to great benefits
• Clinical Research Informaticians in short supply
• Contact info: [email protected]
