Issues in clinical trial design for tumor marker studies.

摘要: Scientific inquiry into the discovery, development, and application of tumor markers is proceeding rapidly. Despite this explosion in research interest, design studies to formally assess value clinical practice inconsistent immature. Indeed, few have been widely accepted standard practice. Many issues must be prospectively considered a methodical, systematic, scientific fashion if progress made development validated tests that will management patients with cancer. The purpose report present discussion involved designing putative which provide sufficient data result incorporation marker We focus on demonstrate validate utility both prognostic predictive markers. Topics covered include patient sample heterogeneity, prevalence marker, capture rate, choice endpoints. This followed by explicit consideration study design, specifically trial randomization schema for factor studies.