title: Design of tumor biomarker-monitoring trials: a proposal by the European Group on Tumor Markers.
abstract: A major application of tumor biomarkers is in serial monitoring of cancer patients, but there are no published guidelines on how to evaluate biomarkers for this purpose. The European Group on Tumor Markers has convened a multidisciplinary panel of scientists to develop guidance on the design of such monitoring trials. The panel proposes a 4-phase model for biomarker-monitoring trials analogous to that in use for the investigation of new drugs. In phase I, biomarker kinetics and correlation with tumor burden are assessed. Phase II evaluates the ability of the biomarker to identify, exclude, and/or predict a change in disease status. In phase III, the effectiveness of tumor biomarker-guided intervention is assessed by measuring patient outcome in randomized trials. Phase IV consists of an audit of the long-term effects after biomarker monitoring has been included into standard patient care. Systematic well-designed evaluations of biomarkers for monitoring may provide a stronger evidence base that might enable their earlier use in evaluating responses to cancer therapy.
authors.affiliation: Department of Clinical Biochemistry, Hillerød Hospital, University of Copenhagen, Hillerød, Denmark.
authors.forename: György
authors.initials: G
authors.lastname: Sölétormos
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Duffy
authors.forename: Daniel F
authors.initials: DF
authors.lastname: Hayes
authors.forename: Catharine M
authors.initials: CM
authors.lastname: Sturgeon
authors.forename: Vivian
authors.initials: V
authors.lastname: Barak
authors.forename: Patrick M
authors.initials: PM
authors.lastname: Bossuyt
authors.forename: Eleftherios P
authors.initials: EP
authors.lastname: Diamandis
authors.forename: Massimo
authors.initials: M
authors.lastname: Gion
authors.forename: Per
authors.initials: P
authors.lastname: Hyltoft-Petersen
authors.forename: Rolf M
authors.initials: RM
authors.lastname: Lamerz
authors.forename: Dorte L
authors.initials: DL
authors.lastname: Nielsen
authors.forename: Paul
authors.initials: P
authors.lastname: Sibley
authors.forename: Bengt
authors.initials: B
authors.lastname: Tholander
authors.forename: Malgorzata K
authors.initials: MK
authors.lastname: Tuxen
authors.forename: Johannes M G
authors.initials: JM
authors.lastname: Bonfrer
mesh_terms: D014408:Biomarkers, Tumor / Q000032:analysis*; D002986:Clinical Trials as Topic; D005060:Europe; D006801:Humans; D008991:Monitoring, Physiologic; D009369:Neoplasms / Q000175:diagnosis* / Q000473:pathology
chemical_list: D014408:Biomarkers, Tumor