title: Endpoints and cutpoints in head and neck oncology trials: methodical background, challenges, current practice and perspectives.
abstract: This article reviews the methodical and statistical basics of designing a trial, with a special focus on the process of defining and choosing endpoints and cutpoints as the foundations of clinical research, and ultimately that of evidence-based medicine. There has been a significant progress in the treatment of head and neck cancer in the past few decades. Currently available treatment options can have a variety of different goals, depending e.g. on tumor stage, among other factors. The outcome of a specific treatment in clinical trials is measured using endpoints. Besides classical endpoints, such as overall survival or organ preservation, other endpoints like quality of life are becoming increasingly important in designing and conducting a trial. The present work is based on electronic research and focuses on the solid methodical and statistical basics of a clinical trial, on the structure of study designs and on the presentation of various endpoints.
authors.affiliation: Department of Otorhinolaryngology, Head and Neck Surgery and Oncology, University Medical Center Hamburg-Eppendorf, Martinistr. 52, 20246, Hamburg, Germany. m.hezel@uke.de.
authors.forename: Marcus
authors.initials: M
authors.lastname: Hezel
authors.affiliation: Department of Otorhinolaryngology, Katholisches Marienkrankenhaus, Alfredstrasse 9, 22087, Hamburg, Germany.
authors.forename: Kathrin
authors.initials: K
authors.lastname: von Usslar
authors.affiliation: Department of Otorhinolaryngology, Head and Neck Surgery and Oncology, University Medical Center Hamburg-Eppendorf, Martinistr. 52, 20246, Hamburg, Germany.
authors.forename: Thiemo
authors.initials: T
authors.lastname: Kurzweg
authors.affiliation: Department of Otorhinolaryngology, Head and Neck Surgery and Oncology, University Medical Center Hamburg-Eppendorf, Martinistr. 52, 20246, Hamburg, Germany.
authors.forename: Balazs B
authors.initials: BB
authors.lastname: Lörincz
authors.affiliation: Department of Otorhinolaryngology, Head and Neck Surgery and Oncology, University Medical Center Hamburg-Eppendorf, Martinistr. 52, 20246, Hamburg, Germany. r.knecht@uke.de.
authors.forename: Rainald
authors.initials: R
authors.lastname: Knecht
mesh_terms: D002986:Clinical Trials as Topic / Q000379:methods*; D019468:Disease Management; D006258:Head and Neck Neoplasms / Q000628:therapy*; D006801:Humans
keywords: Clinical study; Clinical trial; Cutpoint; Endpoint; Good practice; Head and neck cancer