By Anthony Todd Everhart, MD FACP, Consultant, AEQuanimitas, and Rob Rittberg, Clinical Analytics Lead, Revvity Signals Software, Inc.
For medical monitors, the problem with off-the-shelf analytics tools is the lack of tailoring for medical review needs. Medical monitors typically begin by asking clinical questions that are related to core safety domains. These domains are most often specified in medical data review plans and include mandatory monitoring of data such as adverse events, laboratory results, concurrent medications, vital signs, and similar domains. For the most part, domains allow one to identify subject safety concerns or concerns about the investigator. Clinical Data review is among the newest data visualization tools designed expressly for the medical monitor.
But medical monitors are clinical specialists, not data specialists. Many lack the IT expertise needed to manipulate data visualization tools to extract the level of detail promised by vendors and expected by trial sponsors. What medical monitors need is a workflow designed specifically for medical review and easily adaptable for different therapeutic areas and protocols. With a system that provides innovative workflows and advanced analytics designed specifically for medical monitors they can focus their medical data review processes, identify risks early and enable patient safety.