This presentation, led by Ryan Michaud, explored how to best employ IV/IWRS platforms for collecting and managing Patient Reported Outcomes (PRO) data, clinical supply management including drug accountability, visit tracking and randomization.

1. 2 0 1 1 FA L L B I O M E T R I C S W E B I N A R S E R I E S
IVR/IWR...More than just Randomization
Oct. 11, 2011 Presented by Ryan Michaud and Bruce Bailey

2. Ryan Michaud
 Senior Project Manager, Interactive
Response Technologies (Voice/Web)
 8+ years of clinical research experience
 Overseen the successful development of
more than 100 IVR/IWR systems
 BS in Computer Science from Central
Connecticut State University
2011 FALL BIOMETRICS WEBINAR SERIES

3. Bruce Bailey
 Executive Director, IVR/IWR Application Development
 15+ years of clinical research experience
 Overseen the successful development of more than 150
IVR/IWR systems
 BS in Electrical Engineering from Northeastern University
and an MBA from Rensselaer Polytechnic Institute
2011 FALL BIOMETRICS WEBINAR SERIES

4. Agenda
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 Interactive Response Technology (IRT) Overview
 Visit Tracking
 Randomization
 Investigational Product (IP) Management
 Drug Accountability
 Electronic Patient Reporting Outcome (ePRO)
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5. Interactive Response Technologies
Voice and web options
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6. IRT Overview
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 Automated on-line user registration and approval
 Visit tracking with management of washout, open-label and
rescue medication, dose titration and computation
 Interim visit reporting, subject medication resupply
 Cohort and site permission management
 Study discontinuation visits and monitoring (completion, early
termination, break blind)
 Broad spectrum of randomization types including central,
stratified, adaptive, dynamic and biased coin, etc.
 Electronic patient diary capabilities (ePRO) including outbound
reminders and automated compliance reporting
2011 FALL BIOMETRICS WEBINAR SERIES

7. Flexibility and Convenience
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 Trials can utilize both IVR and IWR systems, allowing
users the flexibility to switch between systems during
the conduct of a trial
 On-line registration provides the convenience
registering anywhere you have an internet connection,
and the security of allowing trial administrators to
manage user access and trial participation
 Multi-Lingual availability
2011 FALL BIOMETRICS WEBINAR SERIES

8. Visit Tracking
 More than collecting visit dates
 Commons visits include screening, washout,
interim study visits with/without investigational
product resupply and discontinuation visits
(completion, screen failure or early termination
 Dose tolerability, computation and titration
(double-blind and open-label)
2011 FALL BIOMETRICS WEBINAR SERIES

9. Visit Tracking and Management
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Cohort Management Site Permission Management
 Automatic enrollment cap  Trial administrator controlled
 Flexible to DMC analysis  Global or site-specific
 Trial administrator controlled  By module
 Global or custom notification  Enrollment management,
 Easily updated parameters permission-based
based on study needs  More control with site initiation
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10. Randomization
 Randomization and dispensing
 Randomization and eligibility
 Types of randomization
– Central
– Central by block
– Stratified…not just once!
– Adaptive and dynamic
– Biased Coin
2011 FALL BIOMETRICS WEBINAR SERIES

11. Randomization
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Stratification
 Case example, stratified by:
– Country/Region
– Risk factor
– Sub-study participation (Holter, etc.)
– Current smoking status
 Since country/region is fluid (countries added
and removed during the conduct of the trial)
the above stratification was implemented
dynamically.
2011 FALL BIOMETRICS WEBINAR SERIES

12. Investigational Product Management
 Enrollment rate and inventory…planning is a
MUST!
 No study too BIG or small
 ITK – In the Know with reporting and alerts
 Automated ordering based on threshold and
trigger or predictive algorithms
2011 FALL BIOMETRICS WEBINAR SERIES

13. Investigational Product Management
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 Supply management at site and depot level
 Depot specific or regional supply management
 International or multi-depot management
 Drug expiry tracking and rotation
 Multipart or country specific labeled kits
 Automated reporting and reconciliation of
temperature excursions
 Full drug reconciliation capabilities
 Predictive – it’s possible! And we’re doing it…
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14. Balancing Enrollment and IP Supply
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Utilize predictive
ordering algorithm
to help trials
FIND BALANCE…
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15. Drug Accountability
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 Helps clients in utilizing a uniform IP reconciliation standard
 Provides end users with the ability to track and manage drug
returns from the study sites back to a central depot
Subject IP Depot
assigned Subject reconciled IP shipped processes
IP returns IP and to depot returns
confirmed
2011 FALL BIOMETRICS WEBINAR SERIES

16. Electronic Patient Reported Outcomes (ePRO)
 IVR/IWR based ePRO systems are cost effective
 The ‘thin-client’ model (phone or browser) is readily
available to nearly all patients throughout the world
 Use of an IVR/IWR system ensures timely and accurate
capture of patient data
 System is feature rich with robust reporting capabilities
and a cost effective solution
2011 FALL BIOMETRICS WEBINAR SERIES

17. IRT ePRO: Flexibility
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Middle-Weight Solution
 IVR/IWR based ePRO systems are growing increasingly
popular
 Optimal solution that provides a level of automation and
control not found with paper but without the expense or
complexity of a hand held device
Availability
 Systems can be translated into any language necessary and
are available throughout the world via a ‘thin-client’ – phone
or browser
2011 FALL BIOMETRICS WEBINAR SERIES

18. IRT ePRO: Data
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Systems can be configured to capture any data that can be
represented numerically or via a ‘drop-down’ including:
1) Pain scores on a scale of 0-10
2) Quality of life
3) Quality of analgesia
4) Rescue medication use
– Number of pills
– Date and time taken
2011 FALL BIOMETRICS WEBINAR SERIES

19. IRT ePRO:
Data & InclusionExclusion Criteria
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 Since the ‘core’ IVR/IWR is running on the same
platform as the ePRO system, data captured via the
ePRO system can be used to determine subject
eligibility prior to randomization
– E.g., The randomization module checks:
– The average baseline pain score and requires a
value of 3-9
– At least 4 of 7 diary entries completed in the 7
days immediately prior to randomization
2011 FALL BIOMETRICS WEBINAR SERIES

20. IRT ePRO: Features
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Data Capture Frequency & Timing
 Systems can be set up to capture data at any frequency (e.g.,
1Xd, 2Xd, 3Xd or ad-hoc)
 System can further be configured to only capture data during
specific times (e.g., morning assessments between 8 and noon,
evening assessments between 8 and midnight)
Alerts
 System can be used to send automated alerts to ePRO users
 Text message, email or phone calls to remind callers to take
their IP or as a reminder to make a diary entry
2011 FALL BIOMETRICS WEBINAR SERIES

21. IRT ePRO: Built in ‘Business Logic’
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 Built in business logic prevents the entry of ‘bad’ data allowing
entry of valid responses
 All data entries are confirmed by the user before being
‘submitted’ to the system
– Once confirmed and submitted by the user, the data cannot
be changed
 ePRO questions asked can vary depending on the patients
status
2011 FALL BIOMETRICS WEBINAR SERIES

22. IRT ePRO: Reporting
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 Data captured is available to the project team in near real-time
 Data reports are shown in contextual format (e.g., in a PDF
calendar format) and serial format
 All data can be exported to Excel or PDF
 Compliance reports are also available
– Compliance reports show the total number of diary entries
expected and total received
– Reports show compliance by patient, by site, and globally for
the entire study
2011 FALL BIOMETRICS WEBINAR SERIES

23. Summary
 IVR/IWR Systems…more than just randomization
– Extensive inventory capabilities including
accountability
– A cost effective and middle-weight alternative for
Electronic Patient Reported Outcome
2011 FALL BIOMETRICS WEBINAR SERIES

24. Upcoming Webinars
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Register at www.premier-research.com/webinars
▪ Streamlining Data Management Start-up
15 November at 11:00 am EST
Speaker: Cheryl Silva
▪ Strategies for Implementing CDISC
13 December at11:00 am EST
Speaker: Thomas Kalfas
Listen to past webinars:
▪ The Role of Data Monitoring Committees
Speaker: Ron Kershner, Ph.D.
2011 FALL BIOMETRICS WEBINAR SERIES

25. Questions?
Ryan Michaud
Senior Project Manager, Interactive Response Technologies (Voice/Web)
Email: ryan.michaud@premier-research.com
Phone: 860.610.5510
Bruce Bailey
Executive Director, IVR/IWR Application Development
Email: bruce.bailey@premier-research.com
Phone: 860.610.5511
www.premier-research.com
2011 FALL BIOMETRICS WEBINAR SERIES