Replies to post #75806 on Amarin Corp Plc (AMRN)

[amarininvestor]

OK this is very informative. Then do you have an estimation on what could be the composite rate if interim hits on March?

[Whalatane]

AV excellent post

Thanks for contributing .

Kiwi

[marzan]

Thanks AVII. Are you our Dr. Gainowitz we just inducted into our executive team??

[jessellivermore]

AVII

"It's fairly straightforward. For modeling, once a patient has his first event remove him from the "at risk" population. So, for example, suppose your model shows we are at full enrollment (8000) and 900 events. The population at risk for having a first event is 7100"

Let me see if I get this straight...The relative risks for the population who stays "at risk", control and active arms is not changed. What is changed is the number of enrollees in each arm. Hopefully more are being diluted out of the control arm..The effect is to delay the date of interim.

It seems we should be in a situation like the one you describe..A reduction of 8000 "at risk" to 7100 would have an effect of decreasing the event total 40 primary events over the course of one year, if the composite risk rate was 4.5%. (This compared to a theoretical trial where the risk, and enrollees remain constant). I understand determination of the population probably involves some integral math. But we do know the at risk population is less than 967 souls lower than the RI total population. We start out with no events and a fraction of the final enrollees..The risk rate/1000 pt hours is going to increase over time..I'm guessing the early years total loss of "at risk" patient events is about 40...With a total loss (including the last year 7100) somewhere near 80 events..80 events is about 2.5 months months worth.

calculations done by the "ignorant" method would be off by roughly two and a half months.. ie delayed .."engineering approximation". It could be a little lower than this.. Guess we'll have to wait and see..

Thnx again for the information.

":>) JL

[BioChica]

I like your posts and step by step explanations! Not to mention some screen shots to backup your information!

[sts66]

For modeling, once a patient has his first event remove him from the "at risk" population. So, for example, suppose your model shows we are at full enrollment (8000) and 900 events. The population at risk for having a first event is 7100

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How do you compensate for patients who had an event prior to entering the trial? It would be "first event" for them if it happened while in the trial, but not their "first event" ever. Wondering how this relates to overall risk statistics - those who've had an event before joining the trial are at higher risk for a second one, so how do you weed out overall risk reduction when you include those who don't have a first event until after they're in the trial? Perhaps it all comes out in the wash - they form two groups who are analyzed as separate pools, so you have four main groups, two in control group two in drug group. RRR results would show reduction of 1st event ever for control/drug groups, and a different RRR for a 2nd event, but first while in the trial, i.e. "V reduces chance of 2nd event by X, V reduces chance of 1st event by Y". The former case is the only type of trial where statins have shown any success, the latter zippy.