The Slippery Slope: Is a Surrogate Endpoint Evidence of Efficacy?
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.
John Fauber, Elbert Chu
Staff Writer, MedPage Today
October 26, 2014