9

Vesnarinone, Losartan, Amlodipine, and a lot from my area in heart failure; that initial

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trials went one direction with small events. Then when the real trial was done with larger

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events, it went dramatically in the other direction. So I have this just sense of unease

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anytime you deal with just such small numbers, granted, you can do the same, you can do

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multiple statistical tests on the same numbers and that helps, but it doesn’t get rid of the

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fact they are just really small numbers. So, one of the things that I propose, is later on, is

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to do kind of a simple sensitivity analysis saying, so how many more patients would have

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had to shown up in the Saxagliptin group to move the point estimate or the confidence

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interval into the 1.3, 1.8 test.

1

series, actually the DCCT trial was an example that was almost stopped because of

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harm, because of low event rates, but then because they didn’t believe it even though it

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was a statistically significant test with confidence intervals that were positive, were

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actually worse. So the point estimate was on the wrong side, the confidence intervals at

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95%, confidence intervals were on the wrong side. They decided to keep going, because

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I said, you know, we don’t really have enough events to evaluate what’s going on here,

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and they decided to continue the trial and low and behold they found a big benefit.

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moved to have changed, and my guess is that number would be not big, I don’t know

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how big, but probably not big, and that may give a better sense of - that’s a true

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sensitivity analysis. Saying okay, if patients kind of moved one direction or the other,

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how confident are we and how sensitive are these numbers to the fact that we only have

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40 events. I am not a statistician. I don’t know the ways to do that, but that would have

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been helpful to me.

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We have a whole - after seventeen years. We have lots of examples from

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How many patients out of that 4000 plus trials would have had to have

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