1. re-use of clinical care and of clinical trial data a contract research organisation (cro) point...
TRANSCRIPT
![Page 1: 1. Re-Use of Clinical Care and of Clinical Trial Data A Contract Research Organisation (CRO) point of view EuroRec Conference 2009 Sarajevo Selina Sibbald](https://reader030.vdocuments.site/reader030/viewer/2022032606/56649eaa5503460f94baea77/html5/thumbnails/1.jpg)
1
![Page 2: 1. Re-Use of Clinical Care and of Clinical Trial Data A Contract Research Organisation (CRO) point of view EuroRec Conference 2009 Sarajevo Selina Sibbald](https://reader030.vdocuments.site/reader030/viewer/2022032606/56649eaa5503460f94baea77/html5/thumbnails/2.jpg)
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
![Page 3: 1. Re-Use of Clinical Care and of Clinical Trial Data A Contract Research Organisation (CRO) point of view EuroRec Conference 2009 Sarajevo Selina Sibbald](https://reader030.vdocuments.site/reader030/viewer/2022032606/56649eaa5503460f94baea77/html5/thumbnails/3.jpg)
3
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
![Page 4: 1. Re-Use of Clinical Care and of Clinical Trial Data A Contract Research Organisation (CRO) point of view EuroRec Conference 2009 Sarajevo Selina Sibbald](https://reader030.vdocuments.site/reader030/viewer/2022032606/56649eaa5503460f94baea77/html5/thumbnails/4.jpg)
4
Electronic Data Capture
4
EDC DB
Firewall
CRO
Investigator
Source Document
Pharmaceutical Company
Instant Access toeCRF data
Internet
Instant Access to
eCRF data
![Page 5: 1. Re-Use of Clinical Care and of Clinical Trial Data A Contract Research Organisation (CRO) point of view EuroRec Conference 2009 Sarajevo Selina Sibbald](https://reader030.vdocuments.site/reader030/viewer/2022032606/56649eaa5503460f94baea77/html5/thumbnails/5.jpg)
5
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
![Page 6: 1. Re-Use of Clinical Care and of Clinical Trial Data A Contract Research Organisation (CRO) point of view EuroRec Conference 2009 Sarajevo Selina Sibbald](https://reader030.vdocuments.site/reader030/viewer/2022032606/56649eaa5503460f94baea77/html5/thumbnails/6.jpg)
6
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
![Page 7: 1. Re-Use of Clinical Care and of Clinical Trial Data A Contract Research Organisation (CRO) point of view EuroRec Conference 2009 Sarajevo Selina Sibbald](https://reader030.vdocuments.site/reader030/viewer/2022032606/56649eaa5503460f94baea77/html5/thumbnails/7.jpg)
7
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……!!
![Page 8: 1. Re-Use of Clinical Care and of Clinical Trial Data A Contract Research Organisation (CRO) point of view EuroRec Conference 2009 Sarajevo Selina Sibbald](https://reader030.vdocuments.site/reader030/viewer/2022032606/56649eaa5503460f94baea77/html5/thumbnails/8.jpg)
8
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
![Page 9: 1. Re-Use of Clinical Care and of Clinical Trial Data A Contract Research Organisation (CRO) point of view EuroRec Conference 2009 Sarajevo Selina Sibbald](https://reader030.vdocuments.site/reader030/viewer/2022032606/56649eaa5503460f94baea77/html5/thumbnails/9.jpg)
9
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….
![Page 10: 1. Re-Use of Clinical Care and of Clinical Trial Data A Contract Research Organisation (CRO) point of view EuroRec Conference 2009 Sarajevo Selina Sibbald](https://reader030.vdocuments.site/reader030/viewer/2022032606/56649eaa5503460f94baea77/html5/thumbnails/10.jpg)
10
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
![Page 11: 1. Re-Use of Clinical Care and of Clinical Trial Data A Contract Research Organisation (CRO) point of view EuroRec Conference 2009 Sarajevo Selina Sibbald](https://reader030.vdocuments.site/reader030/viewer/2022032606/56649eaa5503460f94baea77/html5/thumbnails/11.jpg)
11
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
![Page 12: 1. Re-Use of Clinical Care and of Clinical Trial Data A Contract Research Organisation (CRO) point of view EuroRec Conference 2009 Sarajevo Selina Sibbald](https://reader030.vdocuments.site/reader030/viewer/2022032606/56649eaa5503460f94baea77/html5/thumbnails/12.jpg)
12
However, there is huge potential in improving the options available to healthcare providers if we can join Clinical Care and Clinical Research
![Page 13: 1. Re-Use of Clinical Care and of Clinical Trial Data A Contract Research Organisation (CRO) point of view EuroRec Conference 2009 Sarajevo Selina Sibbald](https://reader030.vdocuments.site/reader030/viewer/2022032606/56649eaa5503460f94baea77/html5/thumbnails/13.jpg)
13
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
![Page 14: 1. Re-Use of Clinical Care and of Clinical Trial Data A Contract Research Organisation (CRO) point of view EuroRec Conference 2009 Sarajevo Selina Sibbald](https://reader030.vdocuments.site/reader030/viewer/2022032606/56649eaa5503460f94baea77/html5/thumbnails/14.jpg)
14
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
![Page 15: 1. Re-Use of Clinical Care and of Clinical Trial Data A Contract Research Organisation (CRO) point of view EuroRec Conference 2009 Sarajevo Selina Sibbald](https://reader030.vdocuments.site/reader030/viewer/2022032606/56649eaa5503460f94baea77/html5/thumbnails/15.jpg)
15
Any Questions?
Thank you for yourattention!