The Slippery Slope: Is a Surrogate Endpoint Evidence of Efficacy?

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Language/s: English
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Short Description:

A discussion of the dangers of relying on surrogate outcome measures.

Key Concepts addressed:


Like the others in the clinical trial, Patient No. 11561004 already had tried other treatments for his advanced kidney cancer, but those didn’t work.

So the 69-year-old man volunteered to try an unproven drug that offered some hope he might live longer.

Less than 4 months after starting the novel drug, axitinib (Inlyta), the man — identified only by age and a number in an FDA review of the clinical trial — developed severe abdominal pain, was admitted to the hospital, and died that day from gastrointestinal bleeding.

The drug designed to keep him alive may have hastened his death.

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John Fauber, Elbert Chu
Staff Writer, MedPage Today
October 26, 2014