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.
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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