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New guidance on DVT trials launched

The European Medicines Agency is revising the way drugmakers conduct studies for drugs to treat blood clots, for the first time separating out the clinical requirements for different types of clots.

The European Medicines Agency is revising the way drugmakers conduct studies for drugs to treat blood clots, for the first time separating out the clinical requirements for different types of clots. The updated guideline adds recommendations for testing drugs for superficial vein thrombosis, or clots that are close to the skin, as opposed to deep in the legs. Trials for sVT should enroll patients with extensive, symptomatic clots that are at least 5 cm long, the guideline says. Primary endpoints should focus on extension or recurrence of these clots — via documented extension or recurrence of superficial clots, or documented

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