Calm before the storm ....?, page-70

@Youngandnaive
Re
"and they had reported that an interim analysis would be done by end 1q 2017, so the test for futility was the only analysis possible, considering the slower than anticipated recruitment. No great catastrophe imho."

Agree, it is no catastrophe, but nor is it an absolutely successful read out on efficacy and no reason for anyone to be much more excited than before. Apart from the works of fiction in the online reporting, there is absolutely no detail on efficacy. We were already confident about safety, so it really has become an over-blown exercise.

With your comment around "they had reported that an interim analysis would be done by end 1q 2017, so the test for futility was the only analysis possible,", this is another example of how the message changed over the past year. If you recall the 2nd interim analysis was originally going to be triggered by the trial reaching a 50% level in expected MACE, at which point "overwhelming efficacy" was on the agenda. It was originally an event-triggered activity, not time based.

It was promoted quite widely, and then got watered down to the current situation - a futility test in 1q 2017.

As usual, we were just left to guess what might be happening.