FDA Course

The Statistical Evaluation of Medical Tests for Classification and Prediction

Margaret S. Pepe
Rockville, MD
December 16, 2002

Lecture Slides:

• Session 1: Topics in Study Design
  
• Session 2: Topics in Data Analysis
  

Downloadable Stata programs:

• scrsize.ado, scrsize.hlp- determine power for a one-sample screening study; binary test outcome data.
  
• rocsize.ado, rocsize.hlp - power for a one-sample screening study; continuous data.
  
• aucsize.ado, aucsize.hlp- power for a one-sample screening study based on ROC area under the curve (AUC) improvement
  

These programs require Stata version 7.

Text material

from The Statistical Evaluation of Medical Tests for Classification and Prediction by MS Pepe. Oxford University Press. 2003.

• Chapter 8 : Study design and hypothesis testing
  
• Chapter 8: figures
  
• bibliography