Understanding When to Employ IVR and IWR independently or in Combination

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1 Understanding When to Employ IVR and IWR independently or in Combination Scott C. Wong Sr. Systems Analyst, IVRS Central Management Global Investigational Materials Supply Chain Celgene Agenda What are interactive voice response (IVR) and interactive web response (IWR) systems? Overview of general ITS functionality Benefits of using an IWR ITS System Development Developing ITS Standards ITS Case Study Predictive Supply Reporting Capabilities 1

2 Interactive Voice/Web Response Systems Touch tone telephone or web based technology Caller responds to pre-recordedrecorded prompts (data input) via the phone (IVR) and receives voice response instructions User responds to Pre programmed questions and web text via a secured web page (IWR) and receives on-screen instructions 24/7 Direct interaction with global shared database via the keypad on your telephone or your keyboard E.g. Online banking and Phone reservations for movies/trains/etc Notifications / alerts regarding patient status or activities are generated as a function of activities performed within the system ITS Functionality 2

3 ITS Functionality Subject Enrollment Manage complex randomization schemes Clinical Drug Supply Management Sending Study Medication only when its needed to conserve overall study supplies Manage and Simplify Trial Logistics Site Management Site Statistics and Recruitment Subject Medication Assignment from a single/pooled medication pack list Emergency Subject Unblinding (IVR only?) Electronic Patient Reported Outcomes (epro) Real Time Confirmations and Web Based Reporting IVR vs. IWR Country Participation Data shows fewer errors are made from a data entry perspective using IWR Visual vs. Auditory IWR is better for non site user types where large amounts of data need to be entered Most North American and European sites have used IWR and request IWR In all cases IVR should be used with IWR as an add on. IVR can still be the quickest and most convenient method of input for sites Using both IVR and IWR are generally more expensive then a single platform BOTH MUST BE TESTED 3

4 Cost Benefits IVR vs. IWR can be protocol driven Amount of Data Collected Complexity of Medication Management Number of Stratification and Eligibility questions Study Duration Number of Subjects and Countries ITS Budget Owners Clinical Budget Owners are less influenced by Medication Overage and more concerned with Patient Recruitment Benefits of Using an IWR 4

5 Benefits of using IWR Site Personnel Users Single point of access to event functionality, web reporting and clinical drug accountability via a secure web page Stratification and eligibility questions are provided visually reducing errors in randomization Site and Pharmacy Personnel can review multiple orders in transit Register multiple shipments as having arrived in one transaction Pick and choose ranges of kits that are damaged or missing in shipments rather than selecting kits one by one Request additional copies of event notifications Update Site Contact Details Access Kit Assignment Summary Reports Benefits of using IWR Sponsor Users Online Interactive Site Management Activate/Deactivate Study Sites Online Trigger initial shipments Open/Close enrollment and monitor recruitment Review and Update Supply Strategies for Individual Sites Forecast Supply chain via dashboard reporting Events requiring large amounts of Data Input are simplified Events requiring large amounts of Data Input are simplified using a visual interface Depot to Depot Transfers by quantity or sequence range Manage Expiry and Relabeling activity Access Real Time Subject and Inventory Data 5

6 ITS System Development I want to use an IVR/IWR. An IVRS of moderate complexity requires a week build time It can be done in shorter timeframes: Reusable code libraries Client Specific Standards Reduced IVR systems Simplified Randomization Basic Medication Management 6

7 ITS Build Lifecycle ITS Specification Development: (3 to 4 weeks) Sponsor + Vendor ITS programming (4-6 weeks) Development of user documentation Development of Test Plans and UAT strategy User Acceptance Testing (UAT) : 2-3 days Sponsor testing of the system compared to the specification UAT Participation Global Study Manager, Clinical Research Scientists, Clinical Supplies, IVRS Subject Matter Experts Go Live: (0-3 days) Loading of Live Medication and Randomization listings Ancillary Translations ITS Standards 7

8 Developing Standards for IVR/IWR systems to reduce timelines Core Specification Template Defines Standard Call types required for all studies Screening, Screen Failure, Discontinuation, etc. Defines Standard Terminology Center vs. Site Subject vs. Patient Defines Numbering Format Center Number Subject ID Number Standard Package of Alerts, Notifications and Web Reports List of System Users, Roles and Responsibilities Medication Management trends Approval Procedure for live Data ITS Call Types Locked Down Data Points collected in each transaction Gender, initials, informed consent date, etc. Benefits of a Standard ITS Reduces the learning curve for first time study team users Eliminates system discrepancies across similar studies Less painful specification development procedure Shorter system development time More efficient User Acceptance Testing Familiar Systems are provided to Site Personnel 8

9 ITS Case Studies ITS Case Study 1 Phase 3, Multicenter, Randomized, Double Blind, Placebo Controlled Study to compare the efficacy and safety of Treatment Arm A in Subjects with Myelofibrosis Study Details 2 Treatment Arms (Active and Placebo) 100 subjects 7 day Screening Period 28 day cycles Dose Escalations and Reductions 2 stratification factors (gender and age) 8 ambient and inexpensive kit types (4 doses of Active and 4 doses of Placebo) 9

10 ITS Requirements Should we use IVR or IVR and IWR? When should we send our initial shipment of medication? Do we send all medication at once? What type of Medication Management should we use? Trigger/Resupply? Resupply all or only triggered kit types? Prediction? If we use prediction, what type of Predictive Medication Supply Strategy can we use to ensure medication is readily available at site? Break Out Session 10

11 Prediction Works with a fixed visit schedule Not always suggested to be used in titration studies with numerous dose levels (max 8-10), and frequently expected Unscheduled visits IVRS identifies 2 ranges Check Range how far should the system look ahead to identify a need? Restock Range how much further should the system look ahead and restock for when it identifies patients within the check range? Determining the Need using only Prediction Check Range : 7 Days Restock Range : 2 cycles, or 56 days Patient A TG A Patient B TG B Patient C TG C Using the above example of check range of 7 days and restock range of 56 days, what treatment Groups will be Predicted? 11

12 Prediction: Determining the Need Treatment Group A and C fell within the Check Range, therefore the IVRS looked forward 2 more cycles and calculates the need Assure visit within the check range is included within your calculation Trigger and Resupply with Prediction (AKA Prediction and Buffer) Same thing as Prediction however when need is calculated a buffer stock is taken into account Emergency Resupplies Many titrations Possibility for many unscheduled visits Competitive Recruitment Shipment size is determined on 3 factors: Site inventory that is on site or already in transit If sufficient inventory is available for predicted visits in the check range If sufficient inventory is available for predicted visits in the restock range 12

13 Prediction with titration Depends on study titration rules Using titration doses 10mg, 8mg, 6mg as an example, 3 options: Stepwise up and down titration permitted Predict the current, dose above and dose below No Up titration Predict current dose and one dose below At 8mg predict 8mg and 6mg Only 1 down titration Depending on starting dose Predict current dose and one dose below ITS Case Study 2 Phase 2, Multicenter, Randomized, Open-Label to determine the efficacy of Treatment Arm A versus Investigator s Choice Medication Study Details: 2 Treatment Arms (Treatment A vs. Investigator s Choice Arm) Minimum 21 day screening Period 3 stratification factors (gender, time since diagnosis, Presence of the following poor prognostic factors ) 11 kit types (6 inexpensive kit types of Treatment Arm A of various doses and 5 Different and VERY EXPENSIVE kit types for Investigator s t Choice Arm that t are easily damaged. d 1 of the Investigator s Choice Medication is cold chain) Investigator Choice Arm is dosed by Body Surface Area Treatment arm A can be both Dose Escalated/Reduced Only Treatment Arm A is required for Site initiation Visit 13

14 Investigator Choice Arm Assignment Subject Body Surface Area Kit type 1 Kit type 2 Kit type 3 Kit type 4 Kit type 5 Kit type ITS Requirements Should we use IVR or IVR and IWR? When should we send our initial shipment of medication? Do we send all medication at once? Should we combine different drug types in one shipment? How can we maximize the use of our IVR/IWR to control resupply shipments of Investigator Choice Drug? Should we use Trigger/Resupply? Resupply all or only triggered pack types? Should we use Prediction? 14

15 ITS Reporting Web Reports for Clinical Supplies Patient Enrollment Patient totals Unblinded Inventory Inventory totals by lot and pack type at depot and site Kit Assignment Summary Shows what has been ordered and sent to site by kit ID and shows current kit status Unblinded Shipment Summary Date raised, dispatched, arrived, cancelled, tracking, packs in order Data Extract 15

16 Alerts Expiration Medication is X days from the expiration date DNS, DNC, DND Low depot inventory Set at a threshold so there is time to react Recruitment Milestones Partial and Failed Order Alerts Sent to a predefined and adjustable distribution list Thank you! Questions? 16

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