Surrogate endpoints, or endpoints that take the place of primary disease endpoints, can be measured quickly and cheaply, and allow randomized trials to reduce sample size, study duration and ultimately the cost of drug/device development for regulatory approval. Sound too good to be true? Dr. McCulloch will discuss some of the methodologic controversies, dating back over 30 years, regarding what it takes to prove adequate surrogacy. Dr. Black will discuss a project in which a group he is leading is attempting to gain formal FDA approval for bone density change as a surrogate for fracture risk for trials of osteoporosis therapies.
Speakers: Charles McCulloch, PhD | Dennis Black, PhD | Professors, Epidemiology & Biostatistics, UCSF
Register: http://eepurl.com/g1X35P