Sentinel’s “IMPACT” Beyond Safety: Anti-Coagulant Study Is Early Test

 
• By Cole Werble

The Sentinel post-marketing surveillance system is up and running. Now, FDA is ready to explore uses beyond safety.

FDA is close to taking the first concrete step toward opening up use of its Sentinel post-market surveillance network to investigate questions beyond safety: the agency may be ready as early as next year to unveil a project (the IMPACT-AF Trial) that could lead to outreach to patients who are under-utilizing anti-coagulant drugs.

The IMPACT project will attempt to use Sentinel to identify patients with atrial fibrillation who may be candidates for therapy...

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