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Review
. 2016 Mar;18 Suppl 2(Suppl 2):ii26-ii36.
doi: 10.1093/neuonc/nov270.

Report of the Jumpstarting Brain Tumor Drug Development Coalition and FDA clinical trials clinical outcome assessment endpoints workshop (October 15, 2014, Bethesda MD)

Jennifer L Helfer  1 , Patrick Y Wen  1 , Jaishri Blakeley  1 , Mark R Gilbert  1 , Terri S Armstrong  1
Affiliations
Review

Report of the Jumpstarting Brain Tumor Drug Development Coalition and FDA clinical trials clinical outcome assessment endpoints workshop (October 15, 2014, Bethesda MD)

Jennifer L Helfer et al. Neuro Oncol. 2016 Mar.

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.

Keywords: brain tumor; clinical outcome assessment; endpoints; high-grade gliomas; patient-reported outcomes.

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Figures

Fig. 1.
Fig. 1.
Areas designated as priorities when developing COAs.
See this image and copyright information in PMC

References

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