We are proud to announce after months of hard work and dedication from everyone on the Advera Health development team that we have launched the newest version of RxSignal. RxSignal is our proprietary tool which identifies serious adverse events which are most likely to be added to a drug’s label in the future. This latest version produces more accurate signals that lead to label changes involving more important medical events while producing a lower number of signals that do not lead to label changes or actions by the FDA.
This release shows a predictive rate above 71% for label changes made for precisely the important safety issues that we highlighted while producing less than a 30% false signal rate, allowing clients to have much more actionable and reliable signal information which could greatly alter the perceived safety profile of a drug.
These enhanced RxSignal results were achieved by:
- Restricting RxSignal List to IME and Issues Most Like to be Acted Upon.
The original list of signal RxSignal eligible terms which we have used in our legacy RxSignal were derived from all of the FDA Safety Communications issued between 2008 and 2014. In the current version, we restricted that list to only IME (Important Medical Event) Serious adverse events. This helps us focus on the adverse events which would most impact the safety profile of an individual drug.
To further eliminate false signals, we looked at the complete history of label changes for 109 drugs and for adverse events which were least likely to turn into label changes. We defined these types of adverse events as ones that produced more than 3 signals but had a label change success rate of 25% or less. Any adverse event that met this criteria was excluded from our RxSignal eligible list. This further reduced the false signal rate in the new RxSignal.
- Eliminating Disease Related Issues.
Our clinical team spent significant time scrubbing active adverse event signals to determine whether they were potentially disease related. If the signal could be related to the underlying disease, we have created a new category for those signals called “Active - Disease Related”. Our new RxSignal system focuses on Active signals which are not disease related as these are the signals which most often turn into label changes.
- Enhancing Sensitivity for Issues with Cases Less than Five.
Our team also removed the minimum of 5 cases for active RxSignals. If a signal has less than 5 cases, it can still be active if the lower threshold of the ROR (Relative Odds Ratio) confidence interval is greater than 2.0. We made this change because we found the serious issues could often be added to a drug’s label despite having a lower number of cases so long as the ROR was high enough for that signal.
- Enhancing Sensitivity for Key DME Issues.
There are now 3 DME AEs which are so closely watched by the FDA that they only need 1 case and no ROR minimum to generate a an active signal: PML (Progressive Multifocal Leukoencephalopathy), SJS (Stevens-Johnson Syndrome), and TEN (Toxic Epidermal Necrolysis). Our team found that these adverse events are so serious and so often drug-related that the appearance of 1 case can lead to label change and possible FDA warnings and safety communications.
With the launch of this new version of RxSignal, we are excited to start sharing it with our clients to improve their safety monitoring experience. For those who have not yet seen RxSignal or any of our other analytics that help healthcare decision makers save costs and improve patient outcomes, we invite you see what we have to offer by clicking here.
Chief Product Officer