title: Lessons for tumor biomarker trials: vicious cycles, scientific method & developing guidelines.
abstract: Interview with Daniel Hayes, by Claire Raison (Commissioning Editor) Daniel F Hayes, M.D. is the Stuart A Padnos Professor of Breast Cancer Research and co-Director of the Breast Oncology Program at the University of Michigan Comprehensive Cancer Center (Ann Arbor, MI, USA). Dr Hayes has extensive experience in clinical and translational breast cancer biomarker research, and in drug development and clinical trials. Around 30 years ago, he led the discovery of the circulating breast tumor biomarker, CA15-3, which started his career into further tumor biomarker work. The main thrust of his work since then has been in clinical trials, tumor biomarkers and trying to integrate the two. Dr Hayes is Chair of the Correlative Sciences Committee of the North American Breast Cancer Group (now called the Breast Cancer Steering Committee), and co-chairs the Expert Panel for Tumor Biomarker Practice Guidelines for the American Society of Clinical Oncology.
authors.affiliation: Comprehensive Cancer Center, University of Michigan, Ann Arbor, MI, USA.
authors.forename: Daniel
authors.initials: D
authors.lastname: Hayes
authors.forename: Claire
authors.initials: C
authors.lastname: Raison
mesh_terms: D000970:Antineoplastic Agents / Q000494:pharmacology / Q000627:therapeutic use; D014408:Biomarkers, Tumor / Q000378:metabolism*; D001943:Breast Neoplasms / Q000188:drug therapy / Q000378:metabolism* / Q000473:pathology; D005260:Female; D006801:Humans; D058990:Molecular Targeted Therapy; D009360:Neoplastic Cells, Circulating / Q000473:pathology; D017410:Practice Guidelines as Topic; D057285:Precision Medicine; D057170:Translational Research, Biomedical
chemical_list: D000970:Antineoplastic Agents; D014408:Biomarkers, Tumor
keywords: biomarker validation; breast cancer; clinical validity; companion diagnostics; oncology; regulatory