Every June, on the heels of the ASCO annual conference, comes the American Diabetes Association (ADA) annual conference, with a data deluge that is difficult for even the most diligent industry watchers to keep up with. At time of writing, it is only midday on Tuesday and there are already huge headlines from the conference.
Here are a few, as aggregated by the folks at FiercePharma:
That’s a lot of data by any account and doesn’t even scrape the surface at the 100’s of abstracts and posters that are being presented, adding to the overall evidence pool of diabetes medications.
Furthermore, these top-line read outs can quickly dominate the “what have you done for me lately” mentality of trial results. Obscuring the fact that while they are indeed big pieces of evidence, they are in fact just that—pieces of evidence. It is important to not only understand the results of the latest and greatest trial, but to understand how those results impact the overall body of evidence for a drug.
Luckily for Evidex clients, the analyst team at Advera Health live and breathe data. For our covered indications, like diabetes, the Clinical Evidence database is updated with the new data presented at conferences, typically within 1 week of the conference’s conclusion. This quick turnaround allows our healthcare decision maker clients to not only digest the presented trials, but be able to quickly understand how those data affect the aggregated pool of evidence that has already been established.
Take for example J&J’s Invokana. Data were presented from a PhII, Type 1 diabetes study. The efficacy results were fantastic, however the rate of serious adverse events related to ketoacidosis were shown to be quite high. While not surprising given the FDA’s warning in May of 2015 and the label change in December 2015, it’s important to be able to understand how this trial adds to the collective evidence.
As you can see in the screen shot, an on-demand meta-analysis of AE rates across Invokana’s clinical trials, shows that diabetic ketoacidosis occurred at a higher rate in the treatment arms, than in the control, and is also being reported at a similar rate in FAERS.
This type of analysis, which can be performed on any drug phase II and above in covered indications, is crucial to fully understanding, and putting into context the data that is coming out of ADA.
To see how Evidex can quickly provide you with the insight you need on the data presented at ADA, request a trial of the platform.
Jim Davis, EVP Advera Health Analytics, Inc.