TY - JOUR
T1 - Design of tumor biomarker-monitoring trials: a proposal by the European Group on Tumor Markers
AU - Sölétormos, György
AU - Duffy, Michael J.
AU - Hayes, Daniel F.
AU - Sturgeon, Catharine M.
AU - Barak, Vivian
AU - Bossuyt, Patrick M.
AU - Diamandis, Eleftherios P.
AU - Gion, Massimo
AU - Hyltoft-Petersen, Per
AU - Lamerz, Rolf M.
AU - Nielsen, Dorte L.
AU - Sibley, Paul
AU - Tholander, Bengt
AU - Tuxen, Malgorzata K.
AU - Bonfrer, Johannes M. G.
PY - 2013
Y1 - 2013
N2 - 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
AB - 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
U2 - https://doi.org/10.1373/clinchem.2011.180778
DO - https://doi.org/10.1373/clinchem.2011.180778
M3 - Article
C2 - 23034139
SN - 0009-9147
VL - 59
SP - 52
EP - 59
JO - Clinical Chemistry
JF - Clinical Chemistry
IS - 1
ER -