title: Report of the Jumpstarting Brain Tumor Drug Development Coalition and FDA clinical trials clinical outcome assessment endpoints workshop (October 15, 2014, Bethesda MD).
abstract: On October 15, 2014, a workshop was held on the use of clinical outcome assessments in clinical trials for high-grade glioma of the brain. This workshop was sponsored by the Jumpstarting Brain Tumor Drug Development Coalition, consisting of the National Brain Tumor Society, the Society for Neuro-Oncology, the Musella Foundation for Brain Tumor Research and Information, and Accelerate Brain Cancer Cure. It was planned and carried out with participation from the US Food and Drug Administration. The workshop also included stakeholders from all aspects of the brain tumor community, including clinicians, researchers, industry, clinical research organizations, patients and patient advocates, and the National Cancer Institute. This report summarizes the presentations and discussions of that workshop and the proposals that emerged to move the field forward and toward greater inclusion of these endpoints in future clinical trials for high-grade gliomas.
authors.affiliation: National Brain Tumor Society, Newton, Massachusetts (J.L.H.); Center for Neuro-Oncology, Dana-Farber/Brigham and Women's Cancer Center, Boston, Massachusetts (P.Y.W.); Department of Neuro-Oncology, Johns Hopkins University, Brain Cancer Program, Baltimore, Maryland (J.B.); Center for Cancer Research, Neuro-Oncology Branch, National Cancer Institute, Bethesda, Maryland (M.R.G.); The University of Texas Health Science Center at Houston, School of Nursing, Department of Family Health, Houston, Texas (T.S.A.).
authors.forename: Jennifer L
authors.initials: JL
authors.lastname: Helfer
authors.affiliation: National Brain Tumor Society, Newton, Massachusetts (J.L.H.); Center for Neuro-Oncology, Dana-Farber/Brigham and Women's Cancer Center, Boston, Massachusetts (P.Y.W.); Department of Neuro-Oncology, Johns Hopkins University, Brain Cancer Program, Baltimore, Maryland (J.B.); Center for Cancer Research, Neuro-Oncology Branch, National Cancer Institute, Bethesda, Maryland (M.R.G.); The University of Texas Health Science Center at Houston, School of Nursing, Department of Family Health, Houston, Texas (T.S.A.).
authors.forename: Patrick Y
authors.initials: PY
authors.lastname: Wen
authors.affiliation: National Brain Tumor Society, Newton, Massachusetts (J.L.H.); Center for Neuro-Oncology, Dana-Farber/Brigham and Women's Cancer Center, Boston, Massachusetts (P.Y.W.); Department of Neuro-Oncology, Johns Hopkins University, Brain Cancer Program, Baltimore, Maryland (J.B.); Center for Cancer Research, Neuro-Oncology Branch, National Cancer Institute, Bethesda, Maryland (M.R.G.); The University of Texas Health Science Center at Houston, School of Nursing, Department of Family Health, Houston, Texas (T.S.A.).
authors.forename: Jaishri
authors.initials: J
authors.lastname: Blakeley
authors.affiliation: National Brain Tumor Society, Newton, Massachusetts (J.L.H.); Center for Neuro-Oncology, Dana-Farber/Brigham and Women's Cancer Center, Boston, Massachusetts (P.Y.W.); Department of Neuro-Oncology, Johns Hopkins University, Brain Cancer Program, Baltimore, Maryland (J.B.); Center for Cancer Research, Neuro-Oncology Branch, National Cancer Institute, Bethesda, Maryland (M.R.G.); The University of Texas Health Science Center at Houston, School of Nursing, Department of Family Health, Houston, Texas (T.S.A.).
authors.forename: Mark R
authors.initials: MR
authors.lastname: Gilbert
authors.affiliation: National Brain Tumor Society, Newton, Massachusetts (J.L.H.); Center for Neuro-Oncology, Dana-Farber/Brigham and Women's Cancer Center, Boston, Massachusetts (P.Y.W.); Department of Neuro-Oncology, Johns Hopkins University, Brain Cancer Program, Baltimore, Maryland (J.B.); Center for Cancer Research, Neuro-Oncology Branch, National Cancer Institute, Bethesda, Maryland (M.R.G.); The University of Texas Health Science Center at Houston, School of Nursing, Department of Family Health, Houston, Texas (T.S.A.).
authors.forename: Terri S
authors.initials: TS
authors.lastname: Armstrong
mesh_terms: D014408:Biomarkers, Tumor / Q000032:analysis*; D001932:Brain Neoplasms / Q000188:drug therapy*; D002986:Clinical Trials as Topic; D005910:Glioma / Q000188:drug therapy*; D006801:Humans; D054547:National Cancer Institute (U.S.); D017063:Outcome Assessment, Health Care; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D014408:Biomarkers, Tumor
keywords: brain tumor; clinical outcome assessment; endpoints; high-grade gliomas; patient-reported outcomes