Striking a balance between effective study drug inventory control and efficient management of shipping costs is not always easy when faced with the real-life complexities of clinical trials.
Automated predictive resupply algorithms that help reduce drug waste at clinical sites are now the order of the day for most IRT (IWR/IVR) systems, albeit with varying degrees of effectiveness when it comes to optimizing shipment efficiencies. Even ‘static’ algorithms – e.g., setting a baseline resupply requirement in the system and using alert levels to dictate when to trigger a new shipment—can present complexities with regard to good shipment management.
Not only are shipment costs at issue with all shipment algorithms, but so is study blinding. It’s generally agreed that a minimum resupply of two kits is a good rule of thumb for avoiding “partial accidental unblinding” (otherwise known as creating ‘sneaking suspicions’ in site staff!)’ that can occur from allowing one-kit replacement shipments. This concern is in addition to the extra costs incurred by shipping one kit at a time.
In the Veracity Logic CORE system, allowing/disallowing one-kit shipments regardless of whether predictive or static algorithms are used is a configuration setting determined by the client. When the setting is set to TRUE, the system will ensure that an additional treatment kit is randomly selected and added to any shipment that would otherwise include only one treatment kit. The fact that this addition has occurred is recorded in the system for easy referral by authorized personnel. Shipments containing other non-treatment types of kits – e.g., ancillary, supplemental, or placebo kits – are unaffected by the setting. They will continue to be sent in keeping with their normal resupply requirements, albeit with an additional treatment kit along for the ride!
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