Are you ready?
Most importantly, how well do surrogates correlate with what we care about.
(@JAMAInternalMed we did)
Lots of surrogate approvals. With 4.5 years f/u on market few generate OS data
(@JAMAInternalMed paper we did)
That matters b/c regular approvals typically DO NOT HAVE post market efficacy commitments
So, do you think using unvalidated surrogates is bad for regular approvals, with no post market commitment
[See also 2 government accountability office reports: 2009, 2015]