"I'm not sure what to root for. A trial stoppage for futility would remove AZN's motivation to slow Vascepa approval, but it would also add fire to the nitwits who want to say Omega-3's don't work."
I'm rooting for a stoppage as it would clarify the difference between Vascepa (pure EPA) and other Omega-3's that don't seem to work.
Tasty: QUOTE A trial stoppage for futility would remove AZN's motivation to slow Vascepa approval, but it would also add fire to the nitwits who want to say Omega-3's don't work."
AZN embarked on the Strength trial IMO to save face over the mistake they made when they bought Omthera for 440 million dollars. The drug they acquired in this deal is really just prescription fish oil.... and Epanova at 4 grams a day has just too much DHA, which raises LDL too much to be safe ....every one knows by now that fish oils don't work and the results of the Strength trial should come as no surprise.
One thing to note in STRENGTH is they enrolled an even higher risk of patient than REDUCE-IT - in fact, on average if you compare to REDUCE-IT >180mg/dl or something from memory, these stratified patients just showed something like 40% drop in death in R-IT. Bodes well for AZN that they enrolled such high risk group. Although I still think free fatty acid form will cause more GI side effects and enrolment is going to be much more difficult now... but that being said it will likely show some efficacy. Base case is not futility imo.
The reason you think you don't "understand" the futility boundaries is not because they are too complex; it is because they are too variable from trial to trial.
But here's a <cough> "example" futility scenario for a <cough> "imaginary" 13,000 patient Cardiac outcome trial targeting <cough> 1600 events with <cough> both 50% and 75% interims planned.