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J' Richard Landis, PhD

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Title: J' Richard Landis, PhD


1
Promoting Clinical Research IT within Academic
Health Centers
  • J. Richard Landis, PhD
  • Robert M. Curley, MS
  • Gregg Fromell, MD

Institute for Translational Medicine and
Therapeutics (ITMAT) Center for Clinical
Epidemiology and Biostatistics (CCEB) Clinical
Research Computing Unit (CRCU) Office of Human
Research (OHR) University of Pennsylvania School
of Medicine Philadelphia, PA 19104-6021
2
Personalized Medicine Data
  • identifying data elements from
  • research data, spanning fully the genotypic and
    phenotypic attributes from research studies
  • healthcare systems data, from diverse facilities
    (clinical course of in-/out-patients, labs,
    images, specimens, procedures, outcomes)
  • integrating data elements from basic sciences,
    translational, clinical research, and health care
    domains into individual data records, to enable
    development of personalized medicine models

3
Personalized Medicine Challenges
  • adopt a common vision for comprehensive
    transformation of AHC culture and practice
  • secure a commitment to enterprise-wide investment
    in clinical research IT infrastructure
  • implement a federated data acquisition, storage,
    tracking and analysis strategy
  • deploy a complex technology base, using
    interoperable data standards and systems
  • recruit and retain talented personnel dedicated
    to realizing this vision

4
Penn Center for Biomedical Informatics in
Translation (BIIT)Funded by NCRR within NIH
Clinical and Translational Science Award
(CTSA)October 1, 2006
Clinical Research CTSA
5
Penn Center for BIIT Vision
  • BIIT is promoting vision for a transformed
    enterprise-wide informatics framework for
    clinical and translational science
  • a centralized IT and data architecture within a
    research data facility
  • integrated biomedical and clinical research
    informatics (CRI) toolkits to support the
    biostatistical and statistical genetics methods
    and applications, research computing and
    integrated data analyses required for
    enterprise-wide clinical and translational
    science
  • informatics highway with connectivity (i.e., IT
    plumbing) among all data repositories
  • data standards within and between Penn and CHOP,
    facilitating clinical care and research
    enterprises to implement (i) data
    interoperability, (ii) data integration, and
    (iii) data sharing
  • IT framework to support the educational mission
    of CTSA

6
Advancing Biomedical Informatics Short-term
Goals
  • Re-engineering the Clinical Research Enterprise
  • discovery of all major existing institutional
    data sources and partners who will need to
    participate
  • exploratory strategic planning of what we need to
    do together to support CTSA
  • identification of non-existent, but critical
    institutional resources and infrastructure
  • serious consideration of how we need to go about
    achieving our goals, including procuring the
    necessary strategic planners and funding partners

7
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8
External Perspectives
Advancementof Clinical Research Informatics
(CRI) andResearch IT
9
BIIT and Industry Partnerships
  • Oracle Corp. Clinical Research Informatics
    (CRI) effort for the past 3 years via NCRR HEI,
    and NCRR Feasibility Contract for Integrating
    Expanding Clinical Research Networks (CRNs)
  • IBM Data modeling and integration technologies
  • SUN Microsystems Center of Excellence model
    for leveraging resources across institutions with
    common mission

10
Advancing CRI and IT Consultants
  • Penn external reviewers of Research IT Plans
  • Alan Tackett, PhD, Technical Director of Advanced
    Computing Center for Research and Education
    (ACCRE), Vanderbilt University (30.OCT.06)
  • Christopher G. Chute, MD, DrPH, Head, Section of
    Medical Information Resources, Professor and
    Chair, Department of Biomedical Informatics, Mayo
    Clinic (16.FEB.07)
  • Michael J. Becich, MD, PhD, Chair, Department of
    Biomedical Informatics, Professor of Biomedical
    Informatics, Pathology, Information and Sciences
    Telecommunications, University of Pittsburgh
    (29.MAR.07)

11
Clinical Research Forum (CRF)
Draft Report (Oct. 06) of the IT Roundtable
Working Groupon Functional Requirements for
Clinical Research Informatics (CRI) Motivational
Document!!
12
CRF IT Roundtable Executive Summary
  • AHC CIOs and Deans face many competing demands
    for resources
  • Investigators maintain great perceived risk in
    shunting any of their scarce project funding into
    common institutional research IT infrastructure
  • Exploiting translation opportunities requires
    focus on standards and IT infrastructure for
    clinical research, and institutional commitment
    to their development and deployment
  • Only the CIOs and Deans are in a position to
    achieve this focus they must become champions
    and evangelists for clinical research IT

13
Penn CTSA Center for BIIT
Re-Engineering the Clinical Research Enterprise
via Clinical Research Informatics
(CRI)andBiomedical Research Computing (BRC)
14
Integrated Biomedical and Clinical Research
Informatics for Translational Medicine and
Therapeutics
15
Clinical Research IT Challenges
  • clinical research data in isolated silos
  • siloed data cannot be shared in an integrated
    manner for
  • - protocol tracking and monitoring
  • - subject safety monitoring
  • - adverse event monitoring and reporting
  • - integration with clinical care data
  • - meta-analyses
  • - compilation of accurate meta-data by Clinical
    Research Enterprise
  • systems used to collect the data are not
    compliant, or even stable, posing risks of data
    loss and allegations of poor data integrity
  • cannot accommodate required high-volume clinical
    research in a uniformly timely, compliant, stable
    manner that ensures data integrity

16
CRI Partnership with Oracle Corp.
  • Oracle Clinical (OC) a comprehensive clinical
    data management solution, allowing
    standardization and control of data definitions
    and data usage across a large-scale clinical
    research enterprise, ensuring that data elements
    are defined, managed, and interpreted
    consistently
  • OC is heart of an integrated suite of
    applications (Oracle Clinical Trial Applications)
    supporting clinical research process
  • OC includes
  • Remote Data Capture (RDC) for entering and
    managing data from the investigative site,
  • Thesaurus Management System (TMS) for
    classifying terms against medical dictionaries,
    and
  • Adverse Event Reporting System (AERS) for
    managing patient safety

17
CRI Benefits Immediate Gains
  • increase in number of clinical research databases
    to established standards
  • increase in number of integrated databases that
    are no longer silos of data
  • significant reduction in cost of developing
    compliant databases using Oracle Clinical (OC)
  • increased ability to accommodate the volume of
    clinical research being undertaken
  • reduction in liability risk due to compliance
    violations

18
CRI Benefits Longer-term Gains
  • coordination across multiple informatics groups
    to
  • - reduce duplication of services
  • - consolidate services and facilities, where
    appropriate
  • - provide a more accessible, understandable,
    cohesive set of services to users
  • ability to conduct monitoring, reporting and
    statistical analyses across multiple clinical
    research studies
  • realizing benefits of new trans-study
    infrastructure like a Penn clinical trials
    protocol registry
  • abilities to conduct meta-analyses across
    multiple studies
  • organizing large-scale efforts to obtain external
    funding for Clinical Research Informatics (CRI)

19
Penn CTSA BIIT Vision (contd)
Person-level data1 sharing between Clinical
Care Enterprise and Clinical Research
Enterprise holds the promise of significant
improvements in meeting goals in both
domains 1under secure PHI protection
20
Vision to move from Clinical Care Enterprise as
an Isolated Architecture
21
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22
to Inter-Dependent Architecture Clinical
Care Enterprise Clinical Research Enterprise
23
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24
High Impact of CRF Materials
  • Endorsement of position that
  • Clinical Research Informatics (CRI) cannot
    function without well developed Research IT, w/
    enterprise-wide data governance, data standards,
    system robustness and security
  • CRI becoming more dependent on data access across
    entire enterprise, which in return can benefit
    all domains
  • Enterprise-wide inter-dependencies (Informatics)
    and similarities (IT) argue for a cooperative
    clinical research informatics and IT environment

25
Senior Leadership Advocacy
AHC CRF IT Executive Summary Exploiting
translation opportunities requires focus on
standards and IT infrastructure for clinical
research, and institutional commitment to their
development and deployment. Only the CIOs and
Deans are in a position to achieve this focus
they must become champions and evangelists for
clinical research IT. From AHC Clinical
Research Forum (CRF) IT Roundtable Oct. 2006
26
Conclusions
  • Recommend Biomedical Informatics Advisory
    Committee (SOM, UPHS, CHOP)
  • Develop enterprise-wide comprehensive vision
    (data governance standards, IT infrastructure
    for UPHS, labs, SOM basic/translational/clinical
    research domains)
  • Promote cultural transformation towards
    personalized medicine
  • Seek institutional commitment to major multi-year
    investment in modular implementation of IT
    infrastructure
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