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IVR\IWR…More than just Randomization
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IVR\IWR…More than just Randomization

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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 ...

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.

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IVR\IWR…More than just Randomization IVR\IWR…More than just Randomization Presentation Transcript

  • 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 RandomizationOct. 11, 2011 Presented by Ryan Michaud and Bruce Bailey
  • 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 University2011 FALL BIOMETRICS WEBINAR SERIES
  • 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 Institute2011 FALL BIOMETRICS WEBINAR SERIES
  • Agenda4  Interactive Response Technology (IRT) Overview  Visit Tracking  Randomization  Investigational Product (IP) Management  Drug Accountability  Electronic Patient Reporting Outcome (ePRO) 2011 FALL BIOMETRICS WEBINAR SERIES
  • Interactive Response Technologies Voice and web options2011 FALL BIOMETRICS WEBINAR SERIES
  • IRT Overview6  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
  • Flexibility and Convenience7  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
  • 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
  • Visit Tracking and Management9 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 2011 FALL BIOMETRICS WEBINAR SERIES
  • Randomization  Randomization and dispensing  Randomization and eligibility  Types of randomization – Central – Central by block – Stratified…not just once! – Adaptive and dynamic – Biased Coin2011 FALL BIOMETRICS WEBINAR SERIES
  • Randomization11 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
  • 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 algorithms2011 FALL BIOMETRICS WEBINAR SERIES
  • Investigational Product Management13  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… 2011 FALL BIOMETRICS WEBINAR SERIES
  • Balancing Enrollment and IP Supply14 Utilize predictive ordering algorithm to help trials FIND BALANCE… 2011 FALL BIOMETRICS WEBINAR SERIES
  • Drug Accountability15  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
  • 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 solution2011 FALL BIOMETRICS WEBINAR SERIES
  • IRT ePRO: Flexibility17 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
  • IRT ePRO: Data18 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
  • IRT ePRO: Data & InclusionExclusion Criteria19  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
  • IRT ePRO: Features20 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
  • IRT ePRO: Built in ‘Business Logic’21  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
  • IRT ePRO: Reporting22  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
  • Summary  IVR/IWR Systems…more than just randomization – Extensive inventory capabilities including accountability – A cost effective and middle-weight alternative for Electronic Patient Reported Outcome2011 FALL BIOMETRICS WEBINAR SERIES
  • Upcoming Webinars24 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
  • 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.com2011 FALL BIOMETRICS WEBINAR SERIES