Abstract
The biomarker pipeline to develop and evaluate cancer screening tests has three stages: identification of promising biomarkers for the early detection of cancer, initial evaluation of biomarkers for cancer screening, and definitive evaluation of biomarkers for cancer screening. Statistical and biological issues to improve this pipeline are discussed. Although various recommendations, such as identifying cases based on clinical symptoms, keeping biomarker tests simple, and adjusting for postscreening noise, have been made previously, they are not widely known. New recommendations include more frequent specimen collection to help identify promising biomarkers and the use of the paired availability design with interval cases (symptomatic cancers detected in the interval after screening) for initial evaluation of biomarkers for cancer screening.