How to Utilize an IVRS for Efficient Management of Clinical Supplies

Transcription

1 How to Utilize an IVRS for Efficient Management of Clinical Supplies Scott C. Wong IVRS Senior Systems Analyst Investigational Material Supply Chain Celgene Corporation

2 Objective Provide a basic understanding of how IVR technology is used in clinical trials Explain how IVR systems can manage your clinical supply chain Review the tools IVR vendors use to aid in study/supply management Provide a game plan on how to handle a pooled drug supply within an IVRS

3 What does IVRS Stand for? Ice Vacuum Recognition System Interesting Vermin Removal System International Vaccine Room System Interactive Voice Response System

4 Interactive Voice/Web Response Systems Touch tone telephone or web based technology Caller responds to pre-recorded prompts (data input) via the phone (IVR) User responds to Pre programmed questions and web text via the web (IWR) Direct interaction with global 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

5 IVR vs. IWR Depends on where the study is conducted Westernized Countries using ASCII character sets Data shows fewer errors are made from a data entry perspective using IWR Visual vs. Auditory IWR is also better for non site user types where large amounts of data need to be entered Depot to Depot Transfers Inventory Release Country Lot Approval 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 Using both IVR and IWR are generally more expensive then a single platform BOTH MUST BE TESTED

6 I want to use an IVR. An IVRS of moderate complexity requires a week build time 4 weeks to spec 8 weeks to program, build, test (UAT), release and go live It can be done in shorter timeframes: Reusable code libraries Compact IVR systems Vendors using reconfigurable systems often stress a 1-2 month build time Create sponsor specific Standards Call types, medication management functionality, standard input formats, etc. Pooled Supply systems should fall into a moderate to complex category given the programming and testing involved to ensure an accurate supply chain

7 Medication Management Concepts

8 How does the IVRS know what medication to assign Pack # Packtype Seq # The Medication/Pack List Medication number corresponding to a pack type, sequence (or picking) number Active 2.5 mg Active 2.5 mg Active 2.5 mg Active 2.5 mg Active 2.5 mg Placebo 2.5 mg Placebo 2.5 mg Placebo 2.5 mg Active 5.0 mg Active 5.0 mg Active 5.0 mg Active 5.0 mg

9 Medication for one, Medication for all. Medication is identified by a unique medication ID number printed on the label Medication is sent to site based upon need and not specific for a patient If a patient discontinues, medication intended for that patient can be used for another patient on the same Treatment Group Pooled pack list has medication that is protocol independent until a protocol is assigned

10 An Important Question Do I want to minimize my shipments or do I want to minimize drug wastage?

11 Medication Management Types Trigger and Resupply Resupply UP to (max level) Send X when I hit Y Prediction Prediction with buffer Fractional Pack Prediction Randomization Code Look Ahead

12 Trigger and Resupply Quantities are set up as part of determining supply strategies for sites, and can be based on: Recruitment rate Shipment Lead Time between shipping depot and receiving site Trigger and Resupply Methods (using example of trigger quantity 5 and resupply quantity 10): Resupply UP to (Max level) When I hit 5 (or below) I send what is needed to bring me back to 10» What is sent can vary as it depends when the trigger is reached» Helps minimize shipments I hit X now send Y Fixed value resupply Hit 5 or below now send 10 Be very careful when setting T&R values using this method Trigger and resupply cannot be too close together» Example of Trigger 4 and Resupply 2 if you trigger too far below 4 you may only send 2! Can cause more frequent and small shipments

13 Resupply Quantities Resupply ALL When 1 pack type triggers, IVRS looks across all other pack types and brings other packs up to their resupply level Minimizes shipments countries with long transit times Not good with scarce drug supply Resupply only the triggered pack type Can cause more shipments as one pack can trigger 1 day after the other

14 Determining the Need using only Trigger and Resupply IVRS looks at what is on Site + what is in transit and determines if a threshold has been met If Central Pharmacy across satellite sites is being used, the IVRS will look at the available inventory at the Central Pharmacy before raising any orders for sites Important to specify if medication is ordered AT the trigger or once medication stocks fall BELOW the trigger Vendor and sometimes system specific

15 Prediction Works with a fixed visit schedule Can be tricky when used in titration, studies with MANY dose levels (max 8-10), and frequently expected Unscheduled visits IVRS identifies 2 ranges Check Range how far should IVRS look ahead Restock Range how many visits should IVRS restock for when it identifies a patient(s) in the check range

16 Determining the Need using only Prediction (AKA Projection) 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?

17 Trigger and Resupply with Prediction (AKA Prediction and Buffer) Same thing as Prediction but 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

18 Randomization Code Look ahead Makes the study Randomization Work for Clinical Supplies Useable only when randomization list is stratified by site Dynamic allocation of blocks to a site determine shipment requirements Send medication consistent with next entries in the randomization list as opposed to all types Determine a trigger and resupply for the number of randomization code entries

19 Rancode Look ahead The Process Rand # TG Site # (strata) A B C C B A A B C B C A Look ahead 4 entries Send medication consistent With: A,B,C,C Once 3 entries have been assigned IVRS orders Medication for next 4 entries

20 Summary of Medication Management Concepts Trigger and Resupply Simple math, send what is used Prediction Looking ahead based on scheduled visits Prediction with Buffer Fractional Pack Prediction Good for many dose levels Randomization code look ahead Can be coupled with any of the above Can only be used with a site blocked randomization scheme

21 Not to overwhelm you but method s of randomization can also affect your supply Central Randomization First come first serve A lot of drug needed on site Better overall balance Can have all patients at site on 1 Treatment Group Stratified Dynamic lists Pre stratified Site Stratification can allow for better supply use Randomization code look ahead May impact study balance and can cause randomization numbers to be used out of sequence May not use all randomization numbers within a block Adaptive Randomization adjusts to balance predefined factors across treatment groups according to certain weights Supply is not easy to predict as patient population dependent Zelens Scheme Modified study balance preventing all patients at a site from being on the same treatment group When Balance is important Minimization with Biased Coin Adjusts randomization according to balance of predefined factors with a random element

22 So how do we set up a pooled supply within an IVRS?

23 Vendor Specific Setup IVRS Systems will always start with a front end pack list Depending on the vendor, extracted pack lists may be placed into each protocol specific database or kept as a single front end pack list Shipment Requests must always have the correct protocol within its contents!

24 Pooled Supply Pack list A Pack # Packtype Seq # Protocol Front End Pack List Active 2.5 mg Active 2.5 mg Active 2.5 mg Active 2.5 mg Active 2.5 mg Pack # Packtype Seq # Protocol Pack list Protocol AAA Active 2.5 mg AAA Active 2.5 mg AAA Active 2.5 mg AAA Pack list Protocol BBB Pack # Packtype Seq # Protocol Active 2.5 mg BBB Active 2.5 mg BBB

25 Pooled Supply Pack list B Pack # Packtype Seq # Protocol Active 2.5 mg AAA Single Front End Pack List Active 2.5 mg AAA Active 2.5 mg AAA Active 2.5 mg BBB Active 2.5 mg BBB

26 How will I pool my supply? Pooling Prior to Labeling Pooling packaged medication that is not yet labeled Pooling at the Depot Sending packaged and labeled medication to depots and having the protocol applied on the label at the point of distribution E.g. the label contains all protocol numbers and the correct protocol is checked off at the point of distribution Pooling at Sites Protocol is applied at the point of dispensation to a subject

27 Medication Ordering and Distribution

28 Releasing Medication to IVRS Vendors Must Have: Medication Pack type (as in specification) Sequence or Pack range released Lot Number that will track expiration Expiration Date Location of Medication (Which Depot to release at) Countries approved for use Do not include additional information Look to provide a standard release memo Allow >24hr turn around 2-5 days

29 The Process Initial Shipment: Site Activation/First Patient Screened Resupply As need is determined Order is placed to depot Depot fills order Protocol is indicated at the point of distribution onto the label if using pooled supply at depot Ships to site Site confirms receipt in IVRS Very Important

30 How does medication go from a need to an order?

31 Reports and Alerting

32 Web Reports for Clinical Supplies Patient Enrollment Patient totals Unblinded Inventory Inventory totals by lot and pack type at depot and site Pooled and Protocol specific reporting 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, protocol Data Extract

33 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

34 Communication is the Key to IVRS Success

35 Thank you! Questions?