Enrollment Expectations and Site Management

Case Studies

Problem:

 Your clinical trial will be conducted at more than 50 clinical sites in the U.S. and another 40 internationally. The incidence of disease for the indication of interest varies widely based on geography, but your IRT algorithm treats sites as a unitary phenomenon--a sure path to cost inefficiencies. How can you leverage known statistical differences to control drug waste, shipping costs, and reduce problems with drug allocation?

Solution:

 As part of its CORE system, Veracity Logic's IRT (IWR/IVR) includes the option to accommodate site diversity with respect to known enrollment thresholds.  Clients can designate a site as an anticipated low, medium, or high enroller. For each enrollment threshold, users can specify differences in the initial drug allocation to a site, the baseline drug supply that is to be maintained at a site, and the alert levels which will let the system know when it's time to ship more drug. IRT limitations no longer need to contribute to an overabundance of study drug at one site while the study team wrestles with an insufficient amount of drug at a site performing better. Site assignment to the low, medium, or high enrollment category can also be easily modified at any time the circumstances change.

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