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.

journal_name

Neuro Oncol

journal_title

Neuro-oncology

authors

Helfer JL,Wen PY,Blakeley J,Gilbert MR,Armstrong TS

doi

10.1093/neuonc/nov270

subject

Has Abstract

pub_date

2016-03-01 00:00:00

pages

ii26-ii36

eissn

1522-8517

issn

1523-5866

pii

nov270

journal_volume

18 Suppl 2

pub_type

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