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ANNEXa-I Deep Dive: Part 1 References

Scott Dietrich, Brian Gilbert, and Todd Miano join to review the ANNEXa-I trial, focusing on the primary efficacy outcome and statistics in Part 1 of this 2-part episode series.

ANNEXa-I is one of the most anticipated and subsequently talked about clinical trials in some time. I recorded a solo Rapid Reaction episode to the study, available now.

But to truly help answer so many of our questions, I’m joined by Scott Dietrich, Brian Gilbert, and Todd Miano to do a deep dive on the ANNEXa-I study in a 2-part episode series. Part 1 (this episode) will give a brief overview of the study then discuss the efficacy findings and statistics/methodology.

Why is this study so polarizing? Think there will be further research based on the ANNEXa-I findings? Would the spotlight be on andexanet alfa if it wasn’t so expensive? How should we interpret the primary outcome findings? Any utility in anti-FXa levels? And so much more!

Then Todd Miano makes a guest appearance to answer our statistics/study design questions. How do we interpret these findings with the change in sample size and interim power calculation? Why would they use a more complicated statistical test, the Cochran-Mantel Haenszel (CMH) test, compared to a more simple test? How should we interpret the results with the number of protocol changes? Todd does a masterful job breaking these questions down and helping us understand the study a little better.

Be sure to check out the first ever YouTube video for Pharmacy to Dose, combining Part I and 2 of the ANNEXa-I deep dive, available here

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