Determining priority signs and symptoms for use as clinical outcomes assessments in trials including patients with malignant gliomas: Panel 1 Report

Abstract

Patients with primary brain tumors such as malignant gliomas are highly symptomatic, often from the time of diagnosis. Signs and symptoms (signs/symptoms) can cause functional limitations that often worsen over the disease trajectory and may impact patient quality of life. It is recognized that standard measurements of tumor response do not adequately measure this impact or the impact that a therapy may have to mitigate these signs/symptoms and potentially have clinical benefit. Identifying a core set of signs/symptoms and functional limitations is important for understanding their clinical impact and is the first step to including clinical outcomes assessment in primary brain tumor clinical trials.

Keywords: clinical outcomes assessment; glioblastoma; glioma; outcomes; signs and symptoms.