The document discusses the role of metrology and statistics in biomarker development. It outlines different statistical approaches for classification based on cases and controls as well as measuring interval-scale variables. It emphasizes developing measurement protocols through metrological experiments before assessing if a protocol is adequate for a purpose. Such experiments explore the relationship between a measured property and the protocol, and assess the protocol's performance, repeatability and reproducibility. The document concludes that statisticians can help formulate overall experimental strategies and allocate efforts among different statistical approaches in speeding biomarker development.

1. Metrological Experiments in Biomarker Development (Mass Spectrometry—Statistical Issues) Walter Liggett Statistical Engineering Division Peter Barker Biotechnology Division National Institute of Standards and Technology