Agreed ... but it is is far from common-sense to understand conceptually why in a P3 confirmatory trial you have a hierarchical structure of outcomes. And when the primary outcome fails statistical significance on your secondary outcomes is meaningless.
You would have to write a book to explain why this is so.
But on your second point about a terrible choice of outcomes … I would disagree agree slightly. The outcomes for CHF and LBP were not bad per se. Rather it was the process that generated them which was flawed. So I agree with dplanes point about overconfidence on weak P2 results.
The trouble is running P3 trials as if they were exploratory P2 trials – to learn as you go and to generate interesting sub-group efficacy signals on different endpoints for later testing in ……more P3 trials is completely un-viable.
Agreed ... but it is is far from common-sense to understand...
Add MSB (ASX) to my watchlist
 (20min delay)
|
|||||
|
Last
$1.15 |
Change
0.045(4.07%) |
Mkt cap ! $1.313B | |||
| Open | High | Low | Value | Volume |
| $1.08 | $1.16 | $1.08 | $4.681M | 4.170M |
Buyers (Bids)
| No. | Vol. | Price($) |
|---|---|---|
| 1 | 99680 | $1.15 |
Sellers (Offers)
| Price($) | Vol. | No. |
|---|---|---|
| $1.16 | 31000 | 2 |
View Market Depth
| Last trade - 16.10pm 19/07/2024 (20 minute delay) ? |
| MSB (ASX) Chart |