Title Slide

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Clinical Research Informatics at the University
of Michigan
Daniel Clauw M.D. Professor of Medicine, Division
of Rheumatology Assistant Dean for Clinical and
Translational Research Director, Center for the
Advancement of Clinical Research
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Clinical Research Informatics

• Current State of Clinical Research Informatics
  Effort in CACR
• Engage Web Portal
• BioDBx
• Honest Broker

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Translational Research

• Unique window of opportunity to capitalize on
• our basic science strengths,
• our health services strengths, and
• co-ownership of health system, research
  enterprise and managed care organization

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Translational Research

• Can differentiate us (UMHS, University) from our
  competitors
• Clinical (grow innovative clinical care programs
  around clinical and translational research
  strengths, document effectiveness of innovative
  treatment programs to third parties)
• Research (Increased federal funding, industry
  partnerships, IP, philanthropic donations,
  prestige of health system)
• Education (improved experiences of students at
  all levels, increased national reputation,
  increased value of UM to state government)
• Represents an opportunity to truly link the three
  portions of the UMHS enterprise, and the
  University
• All portions of the enterprise should co-invest
  in this effort

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Major Investment in Informatics

• This will determine success or failure of
  academic medical centers, re the haves and
  have nots
• The haves will be the first to develop linkages
  among activities, establish importance of
  interrelationships, think of the life-cycle of
  academic medical knowledge from bench to bedside
  to practice, and back
• The research informatics of today are the
  clinical informatics of tomorrow
• Metaphorically, goal is a Regional Translational
  Research Center, although the true benefits of
  creating these linkages so far exceed the value
  of the NIH grant that this should not be
  over-emphasized

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Overall Bioinformatics Effort at Michigan
Central Administration with (recruited) Faculty
Lead
CACR-led Clinical Research Informatics
MCBI-led Bioinformatics
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Bedside Bench
E-Research system of unified peer review and
regulatory approvals to ensure appropriate
access to research participants

• BIOINFORMATICS (MCBI)
• Collect / analyze genomic, proteomic,
• microarray, functional imaging data
• Databases to house huge amounts of data

E-Research system of unified peer review and
regulatory approvals to ensure appropriate
access to research participants
Clinical data or sample warehouses
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Clinical Research Informatics

• Introductions
• Current State of Clinical Research Informatics
  Effort in CACR
• Engage Web Portal
• BioDBx
• Honest Broker
• Velos Opportunity
• How Much is Needed
• Next Steps

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Clinical Research Informatics

• Introductions
• Current State of Clinical Research Informatics
  Effort in CACR
• Engage Web Portal
• BioDBx
• Honest Broker
• Velos Opportunity
• How Much is Needed
• Next Steps

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History of BioDBx

• Originally developed by Steve Gruber / Joe Bonner
  for their own research
• Independently chosen by both CACR and Cancer
  Center as clinical research software program of
  choice
• In 2003, Gruber turned over further development
  of BioDBx to CACR

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BioDBx

• Flexible system to manage all types of data
  required for clinical research
• Administrative suite to manage studies
• Case report forms
• Clinical data
• Laboratory data
• Images
• Analysis

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BioDBx

• Failures
• Business model
• Poor management of existing users
• Unfulfilled promises

• Successes
• Business model
• Adopted by most large clinical research groups
• Serves several hundred studies
• Has been key to getting several large grants
  (e.g. BAA) and will be key to future successes

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Clinical Research Informatics

• Introductions
• Current State of Clinical Research Informatics
  Effort in CACR
• Engage Web Portal
• BioDBx
• Honest Broker
• Velos Opportunity
• How Much is Needed
• Next Steps

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Honest Broker

• Features
• HIPAA-compliant storage of sensitive data
• HIPAA-compliant routing of data between clinical
  care and research systems
• Benefits
• Supports research while reducing institutional
  exposure
• Furthers scientific goals with little or no risk
  to human subjects

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Honest Broker

• Challenges
• Provide enterprise-wide Plug-and-Play integration
  of clinical care and research data
• Go beyond contract requirements to provide a
  best-of-breed end-to-end solution for
  interconnecting UMHS many clinical care networks
  with research systems