J' Richard Landis, PhD

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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
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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

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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

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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
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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

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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

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External Perspectives
Advancementof Clinical Research Informatics
(CRI) andResearch IT
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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

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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)

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Clinical Research Forum (CRF)
Draft Report (Oct. 06) of the IT Roundtable
Working Groupon Functional Requirements for
Clinical Research Informatics (CRI) Motivational
Document!!
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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

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Penn CTSA Center for BIIT
Re-Engineering the Clinical Research Enterprise
via Clinical Research Informatics
(CRI)andBiomedical Research Computing (BRC)
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Integrated Biomedical and Clinical Research
Informatics for Translational Medicine and
Therapeutics
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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

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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

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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

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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)

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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
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Vision to move from Clinical Care Enterprise as
an Isolated Architecture
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to Inter-Dependent Architecture Clinical
Care Enterprise Clinical Research Enterprise
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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

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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
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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