...We Welcome You To The Resverlogix HUB withIn The AGORACOM COMMUNITY!

Free
Message: Re: My guesstimate for Patient Years...

Fouremm wrote: "One big mover for RRR though is this is a trial that is based on “time to event” during the trial. My understanding of this is, if for example you compare one event in the placebo group that happens at 3 months with one event that happens at 6 months in the test group, these events are not statistically equivalent. The event in the test group that took longer to get to is statistically favourable to the event in the placebo group. That is my understanding."

You are right Fouremm that BETonMACE is a time to first event trial. My best advice to those confused about the time factor and the need for survival curves and Kaplan-Meier analysis is to do some due diligence. A few resources are below. I am no expert in the statistics of survival/Kaplan-Meier curve analysis in cardiovascular outcomes trials (CVOTs), so I won't comment on it.  

Understanding survival analysis: Kaplan-Meier estimate

The analysis of survival data: the Kaplan–Meier method

Wikipedia Kaplan–Meier estimator

Why Use a Kaplan-Meier Analysis

A PRACTICAL GUIDE TO UNDERSTANDING KAPLAN-MEIER CURVES

Just to clarify that BETonMACE, like most CVOTs, is a first event trial. What that means is that if a patient experiences 2 or more 3-point MACE events during the trial, only the first one counts towards the primary endpoint anaysis. Obviously, if a patient dies than that is the end. But if a patient first has a non-fatal stroke or non-fatal MI, and then later has another stroke, MI or CVD death, then that second event won't count towards the primary endpoint analysis. All ~250 events in the primary endpoint analysis will be first occurrence. However, for many trials there is also a pre-specified total event analysis that includes first AND subsequent events. It is likely in my opinion that BETonMACE will also include a pre-specified total event analysis.

See this paper for EXAMINE total event analysis.

See this paper for REDUCE-IT total event analysis.

BDAZ

 

Share
New Message
Please login to post a reply