Sections
 
Study Design Guidance Tools
 
 
Publications
 Ransohoff DF. How to improve reliability and efficiency of research about molecular markers: roles of phases, guidelines, and study design. Journal of Clinical Epidemiology 2007;(in press) doi:10.1016/j.jclinepi.2007.04.020.

 Ransohoff DF. Response to commentary. Journal of Clinical Epidemiology 2007;(in press) doi:10.1016/j.jclinepi.2007.07.015.

 Pepe MS, Etzioni R, Feng Z, Potter JD, Thompson ML, Thornquist M, Winget M, Yasui Y.   Phases of biomarker development for early detection of cancer.  Journal of the National Cancer Institute  2001; 93(14):1054-61 (July 18).

 Baker SG, Kramer BS, Srivastava S.  Markers for early detection of cancer:  Statistical guidelines for nested case-control studies.  BMC Medical Research Methodology  2002;2(1):4 (February 28).

 Rules of evidence for cancer molecular-marker discovery and validation

 Bias as a threat to the validity of cancer molecular-marker research
 
 
Sample Size Formula and Look-up Tables
 The Diagnostics and Biomarkers Statistical (DABS) Center. This site catalogs current literature and software for statistical studies, study design, and analysis of all the phases of biomarker development.

 Sample Size Calculations for Phase 2 Studies,  326 KB (26 pages) in pdf format.  From the book:  Pepe MS.  The Statistical Evaluation of Medical Tests for Classification and Prediction. New York: Oxford University Press - USA (in press).  (Citation last updated March 11, 2003)
 
 
Related Link
 Bioconductor packages for the analysis of genomic data.  Bioconductor is an open source bioinformatics software project based on R.