OTC Electronic Clinical Trial Recruitment
Transcript of OTC Electronic Clinical Trial Recruitment
Electronic Clinical Trial Recruitment System
Dave RichterGeneral Manager Clinical Innovation LabsGeneral Manager, Clinical Innovation Labs
November 10, 2010
The data in this presentation is representative of theThe data in this presentation is representative of the information known at the time of printing (11/11/2010) and should be confirmed by the UMN Technology Marketing Manager.
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The Problem
Slow translation of clinical research into practice
Research productivity in the U.S. is facing a crisis 1
Recruitment is labor intensive, time consuming costly
Delayed and/or inadequate trial enrollment costs sponsors in excess of $1 billion annually 2
1. Innovation or Stagnation: Challenge and Opportunity on theCritical Path to New Medical Products, U.S. Department of Healthand Human Services, FDA, March 2004.
2. Estimate derived from internal research and discussions with leading trial recruitment firm.
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Background
Medical research spend estimated at $116 billion annually 1
Growth in clinical IT systems fueled by $19 billion stimulus (ARRA)
Proprietary clinical systems create inaccessible silos of information
Mandate to exchange data complicated by confidentiality laws and lack of interoperability standards
Practicing‐physicians lack time to engage in research
No commercial IT systems currently‐offered to address the problem!
1. PricewaterhouseCoopers’ Health Research Institute, Research Rewired, 2008
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Today’s Methods
Multi‐media marketing campaigns, advertising, direct mail, elevator posters, telemarketing, etc.
Purchased research advising where to dig
Manual labor‐intensive chart reviews
Consumer initiated internet search
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At the core….
■ We liberate clinical data
■ We leverage clinical data
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The SolutionElectronic Clinical Trial Recruitment System
Research Portal
EMR
Practice 3 Florida
EMR
Practice 2 Oregon
EMR
Practice 1 Minnesota
Research Sponsor
$$
EMR
Practice 4 Arizona
114
87
63
121
N = 385
Investigator
Electronic Process Flagged Qualified Enrolled
With enrollment completed and confidentiality agreements signed, data is shared electronically with the investigator and the study begins.
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Value PropositionsElectronic Clinical Trial Recruitment System
Research Sponsor
- Speed to market - Lower costs
Investigator
- Faster study design - Faster execution
Medical Practice
- Improved clinical care - Participation fees - Performance tools
Patients
- Engagement in research - Improved clinical care
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Market Opportunity
1. CenterWatch 2009
Annual # studies 50,0001
Patients per study 100
Total patient enrollment 5,000,000
Recruitment cost per enrollee $500
Total recruitment spend $2,500,000,000
Addressable market @ 10% $250,000,000
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Potential Customer Segments
■ Patient recruitment firms
■ Healthcare delivery systems
■ Medical practices
■ Healthcare information exchanges
■ Research networks
■ Contract research organizations
■ Device and pharma research sponsors
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Differentiated Value Propositions
■ Federated network model
■ Optimized query capability of many millions of records
■ Deep expertise in object models, data mapping, classification and vocabulary services
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Kevin A. Peterson, MD, MPHPrincipal Investigator
Background• Associate Professor, University of Minnesota
• Director of Research, Family Medicine and Community Health
• Practicing‐physician
Research Interests• Diabetes
• IT based research networks
• Improving clinical performance
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Status
■ Incubating within business unit at UMN
■ Moving from concept to demonstration pilot phase
■ Developing software with international partners
■ Discussing pilot projects with potential launch partners
■ Developing business model and go‐to‐market strategies
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Electronic Clinical Trial Recruitment System
Q & A