Here is FDA's current thinking on CHF end points, still in draft. However, it gives an insight of FDA's softening stance on the gold standard primary endpoint of survival rate (probably after much pressure form industry) and why DREAM-HF went for the lower risk softer primary endpoint: https://www.fda.gov/media/128372/download
I'd be curious to see how many current P3 CHF studies in clinicaltrials.gov are even using survival as a primary endpoint. Almost looks like the industry has given up on it for any type of study which has a relatively short time frame. Big Pharma may not like what SI stated today that using hospital admissions may not be a good surrogate for survival as show in this study! LOL . He better wait till he signs the contract before he makes those type of statements.
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Here is FDA's current thinking on CHF end points, still in...
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