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