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

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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,… Click to show full 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.

Keywords: clinical trial; trial; eligibility criteria; trial participation; neuro oncology; oncology

Journal Title: Neuro-oncology
Year Published: 2020

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