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Re-Use of Clinical Care and ofClinical Trial Data

A Contract Research Organisation (CRO) point of view

EuroRec Conference 2009Sarajevo

Selina SibbaldDirector

Global Electronic Data Capture (EDC)Quintiles

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Quintiles

4 Fully integrated biopharmaceutical services company offering clinical, commercial, consulting and capital solutions worldwide

4 23,000 staff4 More than 50 countries around the world

4 PURPOSE:4 Quintiles helps to improve healthcare worldwide by

providing a broad range of professional services, information and partnering solutions to the pharmaceutical, biotechnology and healthcare industries

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Electronic Data Capture

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EDC DB

Firewall

CRO

Investigator

Source Document

Pharmaceutical Company

Instant Access toeCRF data

Internet

Instant Access to

eCRF data

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Old World versus New World

Patient Data

•Paper Health Records

Data

Entry

•Clinical Research Co-ordinator enters data into EDC system via Internet

Researc

h Data

• Research database updated

•Study team can view via Internet

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Old World versus New World

Patient Data

• Electronic Health Records

Data Entry

• Redundant step??

Research Data

• Research database updated• Study team can view via Internet

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Clinical and Research Data Overlap

4 50-60% data needed for Clinical Trials is also in the Electronic Health Record (EHR)

4 Good news!

4 Why don’t we just integrate the two systems and transfer the data?4 Saves a lot of work for the investigative sites4 Reduces checking as no room for human error

4 Not quite as easy as it seems……!!

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Clinical Research Regulations

4 Clinical Research very highly regulated4 Summary of FDA Good Clinical Practice:

4 Attributable4 Legible4 Contemporaneous4 Original4 Accurate

4 Multiple regulations/requirements4 Variation across different countries

4 Consider that data used for Healthcare decisions should be equally high quality as it is also potentially life affecting

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Small Study - Possible

4 Sponsor = Pharmaceutical Company4 Trial Management = CRO4 1 investigator site using a commercial EHR

system

4 Several proof of concept studies4 1 to 1 transfers between EDC system and EHR

system

4 Unfortunately….

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Majority of Clinical Studies

4 Sponsor = Pharmaceutical Company4 Trial Management = CRO4 More than 100 investigator sites using a large

variety of commercial and locally developed EHR systems

4 Direct integration is not physically possible4 Costs are prohibitive4 Time needed also prohibitive

4 Data from many current EHR systems is not acceptable to Regulatory Authorities for research purposes

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Obstacles to Data Integration

4 Data ownership/good computer practice4 Secure log in process4 Individual accountability for data4 Audit trail

4 Lack of standardisation4 openEHR4 Archetypes

4 Anonymising data4 Multiple languages4 Free text

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However, there is huge potential in improving the options available to healthcare providers if we can join Clinical Care and Clinical Research

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Potential Improvements

4 Reduced administrative work for the investigative sites4 Easier to perform clinical research4 More investigative sites may be available

4 Ability to mine for potential subjects 4 More predictable recruitment curves

4 Reduced time and costs4 Reduced time to bring new drugs to market4 Less expensive/more options

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Perfect Future

4 EHR systems use standard collection tools4 Good computer practice is built in to all EHR

systems4 Design of the tools and coding dictionaries

facilitates the use of multiple languages4 A secure ‘layer’ allows two way data traffic

4 Anonymous on the way out of the EHR4 Tied back to the correct patient on the way back into the

EHR

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Any Questions?

Thank you for yourattention!