Sei Lee

speaker
547 appearances 9 recordings 1 series first heard Feb 2017 last heard Oct 2022

Sei Lee’s voice in public audio — every appearance, attributed to the second.

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Yeah.
So what I would say is just to kind of try to simplify this, what we looked at were these trials.
And so they get a whole bunch of relatively high risk women, and then they get randomized to either a dummy pill or this bisphosphonate.
And then we follow these groups of women, these thousands of women in each arm over time.
And usually what you see is there is a slow rate of increase of some women have fractures, whether they're on the dummy pill or the medicine.
But at some point after the start of the study, after they start, half of the women get these bisphosphonates.
What you see is that the people who got bisphosphonates have lower fracture risk.
And the people who didn't get bisphosphonates have higher fracture risk.
And what we were trying to do was to see when exactly those separation became big enough for it to be clinically meaningful.
So that's the graphical way of explaining what we did.
Of course, we use kind of fancier math to try to come up with quantitative estimates of time to benefit.
Yeah, I mean, I think that is a very thorny question.
And I think I can say, well, one in a billion isn't clinically meaningful.
And one in one is clearly meaningful.
But I think it's quite subjective to see what is a clinically meaningful difference.
And so one of the things that we look at is how frequent the harms are.
If the harms are happening in one in 10 women,
then I think we can say that the benefits have to be at least on par with that.
Maybe it's a little bit less if the preventing fracture is much more important than avoiding the harm.
So that's one way of answering the question of what is clinically meaningful.
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