The US Food and Drug Administration has approved lecanemab for patients with Alzheimer s disease, even though trial results showed modest cognitive benefits and cases of amyloid-related imaging abnormalities.
Clinical trials have become too costly and burdensome and it s time to reinvent how they are conducted, leading cardiology societies say in a joint opinion.
Looking back on 30 years of successes, such as the game-changing approval of tissue plasminogen activator (tPA), as well as failures in stroke research and treatment.
The DUMAS study showed no benefit on the primary outcome of all ICH with low-dose alteplase followed by mutant pro-urokinase; but there were promising signs of a potential reduced bleeding risk.