A Sponsor recently posed a great question to Veracity Logic: How does your IRT’s (IWR/IVR) predictive resupply algorithm – which analyzes the drug supply needs of each Site based on actual numbers of patients and their certain types of CTMs/dosages – function properly when unscheduled titration and resupply are also allowed for the study?
First: Be sure your IRT system allows sufficient complexity to deal with these situations!The IRT should permit at least two types of unscheduled visits -- unscheduled resupply, typically used to replace lost or missing drug, and unscheduled titration, which allows unanticipated dose level changes.
Standard predictive algorithms may not take these changes into account as a matter of course. The analytic factors tend to focus on how many subjects are in play, how many scheduled visits are upcoming, what kits are needed (if there are no unscheduled modifications), how much drug is required for a two-week supply at a Site, and so on. Some additional considerations must be included to accommodate unscheduled activities.
Veracity Logic’s system, for example, uses static resupply options along with the predictive analytics. Baseline Level (the target level of a kit type to be maintained at the Site) and Alert Level (the number of kits at the Site that triggers a resupply) are added to the Target and Trigger calculations used in the predictive analysis. These will provide the additional drug needed for X number of unscheduled visits.
The appropriate number for X is pre-set at study startup by the client project team (including clinical operations and clinical supply groups) based on parameters they determine to be most realistic for each Site.
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