Abstract

Despite the unmet need, clinical trial opportunities for primary and metastatic central nervous system cancers are limited and clinical trial enrollment is poor. Multiple stakeholders have launched efforts to improve the clinical trial landscape for patients with primary and metastatic central nervous system tumors, including work that promotes the inclusion of patients with brain tumors into clinical trials, re-examination of eligibility criteria, and careful consideration of trial design aspects that may uniquely impact the patients with this disease. Herein, we consider regulatory perspectives from the U.S. Food and Drug Administration and clinician-trialist perspectives from a neuro-oncologist and a medical oncologist.

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