Transcript Document

An integrated approach to
successful eClinical trials
CCRA Seminar: Standards in Electronic Data Capture
London 1 November 2005
Dr Bill Byrom
Product Strategy Director, ClinPhone Group Ltd.
Presentation contents
 Common application of IVR/IWR in today’s clinical trials
 Why integrate EDC and IVR?
 Integration overview
 Case study: Procter & Gamble Pharmaceuticals
 Demonstration movie
 Conclusions
Common IVR / IWR
application
Typical application areas in today’s clinical
trials
IVR/IWR application
 Secure telephone / web access for the performance of
various site-based, sponsor-based, or patient-based
activities.
– Randomization
– Emergency Code Break
– Medication Dispensing and Supply Chain
Management
– Electronic Patient-Reported Outcomes (ePRO)
– Patient Pre-qualification and Recruitment
Recent Survey
ClinPhone webinar April 2005 (n=300)
What is the largest issue or challenge you face with
randomisation and blinding in today’s clinical trials?
a)
Ensuring sites follow the
randomization process correctly
b)
Preventing tampering of code
break envelopes
0%
c)
Providing 24h on-call code break
staff
1%
d)
Managing more complicated
randomization e.g.. stratification
e)
Ensuring randomization methods
are followed in open label studies
f)
Demonstrating internal staff are
blinded to randomization schedule
6%
g)
Other
5%
35%
52%
1%
0%
20%
40%
60%
80%
Recent Survey
ClinPhone webinar April 2005 (n=300)
What is the largest issue or challenge you face with
medication management in today’s clinical trials?
a)
Accurately forecasting the amount
of drug required
b)
Managing the logistics of large
multinational trials
c)
Managing drug
expiration
9%
d)
Limitations on supplies due to
manufacturing
10%
e)
Efficient use of medication in
titration studies
f)
Other
23%
55%
3%
0%
0%
20%
40%
60%
80%
Medication labelling/dispensing
IVR / IWR approach
 Unique Medication Numbering
–
Can be applied to ‘Kit’ of supplies
–
Can be applied to the Individual Dispensing Unit
 Any unit can go to any patient
(randomised to same treatment group)
 Any unit can be used for any treatment period
 Using the smallest dispensing unit gives the most flexibility
 Pooling medication across studies possible
Medication dispensing
and re-supply
Dispensing
call
ClinPhone Inventory
database
Notification:
Arrival /
Damaged packs
Consignment
details
Consignment
request
Drug distribution
depot
Pack
numbers
Shipment
Investigational site
A
B
Stock levels
fall to trigger
level
Why Integrate?
The benefits of eClinical integration
eClinical solutions
CTMS
DSMS
IVR
Safety
System
CDMS
EDC
Why Integrate?
 Remove duplication of data and activities
 Ensure all systems contain the most up-to-date
information at all times
 Simplify processes for the end-user
 Enhanced data access
– Facilitate reporting and consolidation of project
management data through the solution of choice
 Eliminate manual processes
Integration principles
 The main objectives of any integrations:
– Do each task once – remove resource duplication
and the errors introduced by transcription
– Do it in the place that makes sense – decide on the
best overall process and configure systems to fit
– Study specific
The breadth of integration
Example 1: patient enrolment
CTMS
Patient Identifiers,
demography and
visit frequency data
Drug supply
/ re-supply
request
DSMS
IVR
Data for randomisation
(eg. stratification
variables)
Drug
Shipment
Safety
System
Randomisation
Event
Randomisation
and Pack
Number
EDC
Patient
Enrolment
Patient
Data
CDMS
The breadth of integration
Example 2: IVR diary call
CTMS
Drug re-supply
request
DSMS
Tracking
Primary
Efficacy data
IVR
Diary
Data
Patient
completes IVR
Diary
EDC
Data
validation
Safety
alerts
Safety
System
Data
validation
CDMS
Diary Data
Common overlap of data
Randomization
IVR
Dispensing
ePRO
Screening data
Site contact details
CTMS
EDC
Integration overview
How real-time eClinical integration is
achieved at ClinPhone
L
L
L
L
A
A
W
W
E
E
R
I
F
Exporter
IVR / IWR
database
R
XML
message
Event
I
Applicationspecific
message
format
F
Data interchange overview
FTP
site
Application
database
Transformer
Importer
Database
update
XML
message
FTP
site
Applicationspecific
Message
format
Application
IVR-CTMS Integration
CTMS
DSMS
IVR
Safety
System
CDMS
EDC
Integration touchpoints: CTMS
IVR / IWR
Study timeline
Site initiation / qualification
Site activation
Site details
Delivery addresses CTMS
Patient number ranges
Ethics approval
Regulatory approval
Date first drug shipped
FSFV (screening)
Patient tracking data
Randomisation
Patient tracking data
Re-dispensing
Patient tracking data
Withdrawal / completion
Patient tracking data
LSLV
Patient tracking data
Site de-activation
Site / study close
IVR–EDC integration
CTMS
DSMS
IVR
Safety
System
CDMS
EDC
Integration Touchpoints: EDC
Study timeline
IVR / IWR
EDC
Site initiation / qualification
Site activation
Initial shipment?
FPFV (screening)
Subject no.
Initials / d.o.b.
Stratification data
Randomization
Pack dispensed
Pack dispensed
Re-dispensing
Withdrawal / completion
Diary data
LPLV
Site / study close
Withdrawal
Case study
IVR-EDC integration
Procter and Gamble Pharmaceuticals
P&GP’s Best Practices entry
Case study overview
 Two almost identical study protocols
–
IDDM and NIDDM
 Sites
–
USA only
–
17 sites
 Patients
–
180 across both studies
 IVR application (ClinPhone)
–
Real-time activities whilst with patient
–
Randomisation
–
Medication dispensing
–
Medication supply chain management
–
Patient reported outcomes data collection (am and pm diary)
 EDC application (Phase Forward’s InForm)
Integration objective 1
 Manage 6 common data points between systems
– Patient demographic information
– Date of birth
– Initials
– Gender
– IVR generated data
– Randomisation number
– Randomisation date
– Randomisation time
Integration objective 2
 Remove duplication in end-user activities
– Following randomisation call via IVR
– Pass data to InForm
– Enrol an new subject within InForm
– Populate screening and randomisation
eCRFs with IVR delivered data
Integration objective 3
 Populate eCRFs with patient diary data in real-time
– AM fasting blood glucose reading
– PM sum of three daily dosing insulin volumes
 Eliminate site data entry of paper diary data
 Satisfy regulatory requirements for Investigators to take
responsibility for diary data
– Monitor diary compliance in real-time
– Review and report diary data alongside other
clinical data
P&GP key benefits realised
 Site coordinators have less data entry to perform
 The P&GP data management group do not have to check for
discrepancies between common data points in the IVR and
EDC systems
 Queries from discrepancies are eliminated
–
Time and financial benefit for Sponsor and site staff
 Patient diary compliance proactively monitored
 Investigators have immediate access to diary data via EDC
–
Regulatory requirements
–
Improvements in patient care and monitoring
 More efficient workflow
–
May improve database lock time
Demonstration movie
EDC - IVR integration
Integration example
 Screening data entered within EDC application
 Randomization performed using IWR
 Data received by EDC
 Patient diary event sent from IVR / IWR to EDC
Play movie
Summary and
conclusions
The Future of Clinical Trials
 A multitude of eClinical technologies are in use today
–
All are being used in some trials
–
Some are tightly integrated with others
–
Others still used in isolation
 Integration can provide powerful Sponsor and site enduser benefits
 eClinical Trials of the future?
–
Evolution … not Revolution
–
Increased adoption will lead to increased
requirement to integrate
–
Highly integrated “seamless” solutions
New study site details
Site contact detail amendments
Regulatory / ethics approval
CTMS
IVR/web
New patient enrolled / withdrawn/ completed
Site medication inventories
Patient tracking data
IVR central hub of
real-time data
Clinical Trial
Management
System
CTMS
Patient withdrawal
Patient completion
Randomization data
Dose adjustment / calculation data
EDC
New patient enrolled
New study site
IVR/web
Randomization number
Medication pack number(s)
IVR diary data
Dispatch notification
Pack list and pack list updates
Expiry date updates
DSMS
New study site / details
Shipment requests
IVR/web
New
study
site
Electronic Data
Medication
pack
IVR /
Capture
dispensed
web
System
EDC
DSMS
New patient
enrolled
Drug Supply Chain
Management
System
For more information
www.clinphone.com
[email protected]