Mass spectrometry proteomic diagnosis: enacting the validation paradigm
  This paper presents an approach to the evaluation and validation of mass spectrometry data for construction of an `early warning' diagnostic procedure. We describe implementation of a designed experiment and place emphasis on the consistent and correct use of validation based evaluation - which is a key requirement to achieve unbiased assessment of the ability of mass spectrometry data for diagnosis in this setting. Strict adherence to validation as a scientific principle will however typically imply that the analyst must make choices. Like all choices in statistical analysis, validation comes at a cost! We present a detailed and extensive discussion of the issues involved and propose that much greater emphasis and requirement for validation would enter clinical proteomic science. 
Bart J. A. Mertens, M. E. de Noo, R. A. E. M. Tollenaar, A. M. Deelder