Re: My estimate for Top Line Data Announcement...is a shocker!
in response to
by
posted on
Jun 05, 2019 08:27PM
I used a very slow process of getting patients back into the center...only 2/day/center. And by assuming 80/20, I assumed the slowest possible followup. My objective was to get to the sensitivity of the ending of the followup.
I don't know if getting to 260 was an objective...I viewed it more as a side benefit. Also, I also have allowed for the adjudication of the last of the MACE events to not take too long. The adjudication of the 250th event (or 250+x event) could be the deciding factor on how long it will take. Also, if the RRR is going to be statistically significant, 250 or 260 won't be that different.
In short, it won't take more than just over a month to finish off the 2400 patient followup. Adding all manner of speed bumps, I still get a top line data announcement in July.