Transcript 2400 scans

Case study of eCRF implementation
in a neurological clinical trial
with CT scans
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Study type
• Randomised, double-blind, placebo controlled study
• Phase IIIb
• 100 centers in 15 european countries
• 800 patients to be included in 3 years
3 months follow-up per patient
• 2 to 4 CT-scans per patient (2400 scans planned in
total)
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Data Chart
Visit
Hour / Day
Window
1A
Baseline
(3 Hrs <X 4 Hrs)
D0
Demographics
x
Medical History
x
In- / Exclusion Criteria
x
Pregnancy Test
2
3
4
5
1 Hour #
 5 Min
2 Hrs#
+15 Min
24 Hrs#
+1 Hr
D1
7 Days#
+1 Day
D7
30 Days#
+2 Days
D30
90 Days#
+14 Days
D90
x
x
x
x
x (+)
Vital Signs
x
x
x
x
x
x
x
Concomitant Therapy
Adverse Events
x
x
x
x
x
x
x
x
x
x
x
x
x
x
12-Lead ECG
x
CT Scan
x
NIHSS
x
Pat. Termination Record
(+) if applicable - (*) in case of clinical deterioration
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1C
X
Drug / Placebo
Informed Consent and subject
information
IVRS
Contact
Physical Exam.
Trial Drug
Admin
1B
x
x
x
x
x (*)
x (*)
x
x
x
x
x
Review Commitee
• 3 experts must review all CT scans to check inclusion
criteria, adverse events and make radiological
measurements
• Experts 1 and 2 review CTs independantly
• Expert 3 will review Experts 1 and 2 evaluations, and
in case of discrepancy, will give final decision
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Classical solution : paper and films
• Paper CRF
• Radiographic films
• Paper evaluation forms
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IVRS
Expert 1
Investigator
Expert 2
Expert 3
CRO
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Classical solution : measurements
• Hypothesis :
- 2400 scans (800 + 800 + 400 + 400)
- 10 % will forget anonymization
- CT 1 & 2 sent together, CT 3 & 4 sent together
• => 7200 CT copies
800 + 400 initial EM by investigator
120 requests for lack of anonymization
720 additional CTs
120 additional EM by investigator
1200 + 1200 EM from CRO to experts 1 & 2
1200 + 1200 EM by experts 1 & 2 to CRO
1200 EM from CRO to expert 3
1200 EM by expert 3 to CRO
• Total : 7920 CT copies + 8520 express mails
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Classical solution : measurements
• Optimistic hypothesis :
- invest to CRO : 2 days
- CRO analysis and data entry : 2 days
- EM to experts 1 & 2 : 1 day
- review by experts 1 & 2 : 1 day
- EM by experts 1 & 2 to CRO : 1 day
- CRO analysis and verification : 1 day
- EM to expert 3 : 1 day
- review by expert 3 : 1 day
- EM by expert 3 to CRO : 1 day
=> Best case : 11 days
if anonymization required : + 3 days = 14 days
• Pitfalls :
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- difficult measurements with films
- requires double data entry by CRO
Electronic solution (75 %)
• Paper CRF for investigator
• Electronic images copied onto CD-Rom
• Electronic evaluation forms
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IVRS
Expert 1
Investigator
Expert 2
Expert 3
CRO
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Electronic solution : measurements
• Hypothesis :
- 2400 scans (800 + 800 + 400 + 400)
- 10 % will forget anonymization
- CT 1 & 2 sent together, CT 3 & 4 sent together
• => 1200 CD roms burnt by investigator
800 + 400 initial EM by investigator
240 anonymization by CRO
no additional CD-Roms
no additional EM by investigator
2400 upload by CRO in database
no EM from CRO to experts 1 & 2
no EM by experts 1 & 2 to CRO
no EM from CRO to expert 3
no EM by expert 3 to CRO
• Total : 1200 CD-roms + 1200 express mails
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Electronic solution : measurements
• Optimistic hypothesis :
- invest to CRO : 2 days
- CRO analysis and data entry : 2 days
- EM to experts 1 & 2 : 0 day
- review by experts 1 & 2 : 1 day
- EM by experts 1 & 2 to CRO : 0 day
- CRO analysis and verification : 0 day
- EM to expert 3 : 0 day
- review by expert 3 : 1 day
- EM by expert 3 to CRO : 0 day
=> Best case : 6 days
if anonymization required : + 1 day = 7 days
• Advantages :
- electronic images allow digital measurements
- anonymization can be done by CRO electronically
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Other advantages
• Direct access to data for all authorized users
• Real-time follow-up
• Audit trail
• Alarms
• Performance measurements
• Investigators can access experts evaluation
• Electronic images and measurement tools
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Security issues
• Encryption
• Electronic signature
• Profile management
• Audit trail
• Database protection (firewall, physical security)
• Back-ups
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