Long gone are the days when Interactive Response Systems (IRT/IWRS/IVRS) in clinical trials were thought to be just tools for simple 1:1 assignment of subjects to treatment groups, a no-brainer easily replaced by a few lines of code tagged onto an EDC platform. IRTs are now recognized as go-to systems of choice for controlled management of:
- Sophisticated randomization strategies like dynamic/minimization, adaptive randomization, forced randomization, and other new approaches to statistical validity within a clinical trial - all built-in, all validated.
- All aspects of assignment of drug to subjects, including complex algorithms for dose control and product allocation
- All aspects of drug inventory at clinical sites and depots, including handling of extraordinary circumstances like damaged, missing, mis-administered, and temperature deviated IP supplies, scheduled and unscheduled resupplies, baseline stock maintenance, and alerts
- Subject activity windows, Unblinding activities, protocol deviations, including authorization code management
- Shipping processes across domestic and global sites and depots, allowing organized diversity of shipment handling on a site basis
- And more...
Early collection of metrics for all of these critical aspects of trial performance is another key reason why IRTs are in demand, especially in the modern environment of risk-based study management strategies which are highly dependent on current data. Here are just two examples of how an IRT puts you way ahead in this arena:
- Site users MUST engage the IRT system to screen and enroll subjects in real time in order to obtain the critical Subject ID and, later, to know which study kit to assign at each visit. By contrast, in the EDC world, data entry is often after the fact; site users can delay system engagement for an indeterminate period of time, causing a lag in metrics and a greater headache for CRAs and project managers.
- In the Veracity Logic IRT system, color coding capitalizes on human psychology to further ensure speedy data collection. Activities that don't require system engagement in order to get something essential back -- for instance, a requirement that sites enter screen failures into the IRT has no immediate reward -- could end up imitating the delayed entry problems of EDC systems if no further prods to site users were provided. But by highlighting in bright RED any subjects lagging behind their next scheduled visit, not only are site users motivated to eliminate the red from their table views, but they also know they'll soon be hearing from their CRA who is seeing the same thing!
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