The FASTEST trial demonstrated that while recombinant Factor VIIa reduced intracerebral hemorrhage growth by less than 2-3 ml (a clinically meaningful difference), this did not translate into improved patient-oriented outcomes, highlighting the critical importance of focusing on patient-centered outcomes rather than disease-oriented metrics in clinical trials.
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FASTEST: rFVIIa vs Placebo for Acute Intracerebral Haemorrhage追加:
Intracerebral hemorrhage continues to have a high mortality and morbidity rate. Authors in the fastest trial attempted to see if factor 7A has any role in ICH. However, was there any clinical benefit? I think what's interesting here to me, and probably to you as an EMA listener, is there's a dissociation that was observed between what was supposed to be a clinically meaningful difference in intracranial hemorrhage growth. That's what they said. If this thing grew by less than two or three ml, that is going to translate into clinical benefit, and it just didn't it. And I think for me, that highlights the importance, and we talk about it on the show a lot, of focusing on these patient-oriented outcome assessments. So, they got exactly what they wanted out of the disease-oriented outcome, but it didn't impact the patient-oriented outcomes at all.
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