Clinical outcome assessment in malignant glioma trials: Measuring signs, symptoms, and functional limitations

Jaishri O. Blakeley, Stephen Joel Coons, John R. Corboy, Nancy Kline Leidy, Tito R. Mendoza, Jeffrey S. Wefel

Research output: Contribution to journalArticle

Abstract

The shared goal of all parties developing therapeutics against malignant gliomas is to positively impact the lives of people affected by these cancers. Clinical outcome assessment (COA) tools, including measures of patient-reported outcome, performance outcome, clinician-reported outcome, and observer-reported outcome, allow patient-focused assessments to complement traditional efficacy measures such as overall survival and radiographic endpoints. This review examines the properties of various COA measures used in malignant glioma clinical trials to date and cross references their content to the priority signs, symptoms, and functional limitations defined through a community survey conducted by the National Brain Tumor Society. The overarching goal of this initiative is to identify COA measures that are feasible and have appropriate psychometric properties for use in this patient population as well as highlight where further development is needed.

Original languageEnglish (US)
Pages (from-to)ii13-ii20
JournalNeuro-oncology
Volume18
DOIs
StatePublished - Mar 1 2016

Keywords

  • clinical outcome assessment
  • clinical trials
  • endpoints
  • malignant glioma

ASJC Scopus subject areas

  • Oncology
  • Clinical Neurology
  • Cancer Research

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