Surrogate Endpoints and Non-randomized Trials. Roseann White Humble Biostatistician. Type of non-randomized trials. Diagnostic/Natural History trial Single arm trial that shows superiority/non-inferiority in clinical endpoint Example: Safety concerns for placebo or current practice.
Example: Safety concerns for placebo or current practice
Re-statement of Prentice Criteria for a surrogate endpoint
What if there is no therapy?
*Chapter 17 in The Evaluation of Surrogate Endpoints edited by T. Burzykowski, et. al. Springer, 2005
what\'s a statistician to do?
Example: Using angiographic binary restenosis as a surrogate at 6 months for drug eluting stent whose drug has not completely eluted at six months