Last week we officially launched our revamped platform Evidex, which now includes easy-to-navigate evidence from both clinical trial data and real-world adverse event reports. To give you an idea of how simple it is to complete a thorough drug review in this platform, I'll go through a step-by-step overview of how to compare multiple diabetes meds.
A use case for Evidex can be seen when evaluating Merck’s DPP-4 inhibitor, Marizev (omarigliptin) for diabetes, which expects FDA approval in 2016. Comprehensive review of Marizev’s available safety and efficacy data will also need to include all of the DPP-4 medications for comparison. With four DPP-4 drugs already on the market and two in late-stage clinical trials, gathering all of the most current evidence is an extremely time consuming task.
In addition to the real-world post-market safety analysis that can be done for the on-market drugs, Evidex will allow you to quickly gather and analyze all of the clinical trial evidence as well. In the Studies tab we give users a listing of all Phase II and above clinical trial sources, which in itself has been a big time-saver for many of our clients. Here you can see there are 105 clinical trials that have been databased for Januvia (sitagliptin) alone.
Using the meta-analysis capabilities in the Safety Summary, a reviewer could quickly compare Januvia (sitagliptin) to Marizev (omarigliptin) and other DPP-4 drugs using data from all documented clinical trials, or filter the information based on specific baseline and/or patient characteristics by using the Advanced Filter. All data can also be downloaded in .csv or pdf format for later use or documentation.
A user can next dive deeper into the safety data to look at specific adverse events and compare rates across drugs. Having the ability to make these comparisons for drugs awaiting approval or that are newly approved has been a powerful addition to the platform, as real-world adverse event data are not available for these medications until at least 3-6 months after they have been on the market.
For drugs on the market, the clinical evidence can be compared to what is being reported in the real-world. The image below displays the rate of Interstitial Lung Disease seen in clinical trials ("Treat rate") compared to what has been reported through FDA’s Adverse Event Reporting System (FAERS) post-market ("FAERS rate") in patients taking Januvia (sitagliptin). Also important to note is that this AE has triggered an Active RxSignal, which means it is a serious adverse event being reported at an elevated rate in the real-world and may warrant an FDA label change in the future.
Efficacy can also be evaluated across multiple trials, using endpoints of your choosing. Evidex provides users with summary tables which aggregate trial data, as well as a breakdown of individual outcome results from each trial. Data points can be saved in .csv or pdf format, which allows you to examine the measurement changes across all trials.
We are offering complimentary 7-day trials of the platform to qualified organizations so you can see how powerful these tools are for yourself. As one of the Product Specialists for Advera Health, my assistance will also be available to you through the duration of your trial.
Contact a member of our team to request a trial of Evidex.