Industry statistics indicate that 50% of the sites initiated for a clinical trial enroll 0-1 subjects; with 25% enrolling none at all. With numbers like these, decisions on where and how to distribute precious and expensive study drug become a serious matter for senior management and project teams.
Elaborate forecasting and predictive tools have been developed, and do provide a leg up on the formerly blanket ‘static’ algorithms which could only administer rules like “deliver 5 kits of each type to Site A at the point of site activation.” Predictive algorithms, for instance, can do things like determine from site enrollment and subject statuses how much drug needs to be on site – and by when – in order to ensure a 10 day supply of drug for current enrollees and for the percentage of new demands expected over the coming month. Applying site enrollment expectations to algorithms also helps.
But, given the statistics on site enrollments, program managers might consider additional, often overlooked approaches to study design that can help minimize drug waste.
Here are just two examples of strategies that can be applied when setting up the IRT (IWR/IVR) system for a clinical trial:
- Issue the initial shipment request for a site when the first subject screens rather than at site initiation or activation. This at least eliminates shipments to the sites that enroll zero subjects!
- Add a ‘randomization eligibility’ visit to the study design. Sites receive drug only after confirming each site has subjects who are eligible to be randomized into the study. The initial shipment request for a site is then issued after the 'rand eligible' visit has been recorded. This approach greatly reduces drug wastage at each site.
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