1. re-use of clinical care and of clinical trial data a contract research organisation (cro) point...
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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!