The power of notifications in trials with image-based eligibility criteria


We are seeing more and more imaging trial protocols requiring the analysis of subject eligibility to occur under tightening deadlines.


Take for example a cardiovascular study using centralized analysis of an Intra-Vascular Ultrasound (IVUS) to determine whether a subject should be included in the trial. In this particular protocol, the patient remains in the hospital waiting for the result of the IVUS analysis which, if positive, requires another Cath Lab procedure to occur immediately. The analysis of the IVUS must occur within six hours of initial scan, at a remote core lab specializing in this type of modality. Failure to meet the eligibility turnaround time means the subject must either remain in the hospital another day, or else not be included in the study. The cost of either of these results to the study is very significant.

Obviously, this protocol would be impossible to implement using couriers, and completely impractical using ad hoc file transfer protocols. With IVUS scans ranging to 2 GB in size, the time required to transfer these over the open Internet is simply impractical. Furthermore, unless the electronic transfer occurs over a managed, monitored network, the transfer of this amount of data is so slow and unreliable as to frustrate even the most committed investigator site. Of even greater importance is the fact that the image sets must be QC’d as soon as possible upon delivery, so the analysis can proceed under its tight deadline. In a triage situation of this kind, the management of trial logistics needs to be flawless, and therefore communications of workflow events must be robust enough to ensure the proper outcomes. Relying on individuals to communicate tactical steps is unrealistic given their already busy schedules. Therefore, a new level of automation must exist in order to keep pace.

From my perspective, the required logistical automation must include robust notification capabilities. Automated notifications can have a significant positive effect on quality, particularly if they are sophisticated enough to provide both “Push” alerts to any number of simultaneous stake holders, as well as a common dashboard, accessible by investigator sites, monitors, PMs and trial coordinators alike. These notifications, to email, cell phones or in a real time portal page, must show exactly where in the process the image sets and eCRFs are at any point in time. The real-time integration of these alerts, through Web-Services, with internal core lab systems ensures that the flow can be tracked through a single continuous timeline, from investigator site to core lab interpretation.

This level of automation enables trials with increasingly aggressive eligibility timelines to proceed in ways never available until now. Conversely, the absence of integrated notifications creates friction in a system that has very little built-in slack, slowing processes down, and ultimately affecting the patient waiting for the results of the inclusion analysis.

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