Signal validation is the process of confirming a new potentially causal association, or a new aspect of a known association, of a drug-event combination. When validating a signal, GVP IX recommends that the following elements should be considered:
- Previous awareness
- Strength of evidence
- Clinical relevance and context
The full module document provides numerous examples of these elements, so won’t be discussed in detail here. However, having access to robust ICSR data, both for individual cases and in aggregate is necessary to justify further analysis.
Although tools used to perform signal validation are not specifically addressed in GVP IX, having access to a platform such as Evidex Signal Management to perform a signal validation analysis expedites this stage. It is critical to have a process in place to efficiently identify previous work on the potential signal or any past inquiries and to then quickly identify related ICSRs and analyze specific case series.
Given that all past actions involving a potential signal are tracked and stored within Evidex Signal Management, a drug safety professional can quickly understand all of the information held or known by the organization. Data redundancy measures are implemented to protect against any type of data loss. And given that no knowledge solely sits within any one employee, team risk is significantly minimized.
Evidex’s intuitive user interface provides efficient navigation of drug-event combinations and helps to characterize an adverse event with out-of-the box features such as whether the AE Is on label, serious, or disease related, as well as any signal status designations that may have been previously applied.
Using Evidex’s custom analytics functionality allows a user to quickly pinpoint cases of interest, highlight commonalities, discover the potential of drug-drug interactions, and use embedded, advanced statistical engines to stratify disproportionality scoring. Given the tight integration with Evidex Signal Management, a reviewer can then document the steps taken and outputs produced, to provide an audit ready log.
At this stage a decision will be made to determine if the signal is non-validated or that it is in fact a validated signal that is in need of prioritization and further assessment considering all available data.