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Optimizing eligibility criteria and clinical trial conduct to enhance clinical trial participation for primary brain tumor patients


Abstract

Building on an initiative to enhance clinical trial participation involving the Society for Neuro-Oncology (SNO), the Response Assessment in Neuro-Oncology (RANO) Working Group, patient advocacy groups, clinical trial cooperative groups, and other partners, we evaluate the impact of eligibility criteria and trial conduct on neuro-oncology clinical trial participation. Clinical trials often carry forward eligibility criteria from prior studies that may be overly restrictive, unnecessary, and needlessly limit patient accrual. Inclusion and exclusion criteria should be evaluated based on the goals and design of the study and whether they impact patient safety and/or treatment efficacy. In addition, we evaluate clinical trial conduct as barriers to accrual and discuss strategies to minimize such barriers for neuro-oncology trials.

Abstract

Building on an initiative to enhance clinical trial participation involving the Society for Neuro-Oncology (SNO), the Response Assessment in Neuro-Oncology (RANO) Working Group, patient advocacy groups, clinical trial cooperative groups, and other partners, we evaluate the impact of eligibility criteria and trial conduct on neuro-oncology clinical trial participation. Clinical trials often carry forward eligibility criteria from prior studies that may be overly restrictive, unnecessary, and needlessly limit patient accrual. Inclusion and exclusion criteria should be evaluated based on the goals and design of the study and whether they impact patient safety and/or treatment efficacy. In addition, we evaluate clinical trial conduct as barriers to accrual and discuss strategies to minimize such barriers for neuro-oncology trials.

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Additional indexing

Item Type:Journal Article, refereed, original work
Communities & Collections:04 Faculty of Medicine > University Hospital Zurich > Clinic for Neurology
Dewey Decimal Classification:610 Medicine & health
Language:English
Date:15 May 2020
Deposited On:23 Mar 2020 16:22
Last Modified:29 Jul 2020 14:39
Publisher:Oxford University Press
ISSN:1522-8517
OA Status:Closed
Free access at:Publisher DOI. An embargo period may apply.
Publisher DOI:https://doi.org/10.1093/neuonc/noaa015
PubMed ID:31974566

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