Identifying appropriate external control datasets in support of future glioblastoma clinical trials leveraging external data.

ABSTRACT:

Background

Recent interest in leveraging external data for clinical trial design and analysis in glioblastoma has raised questions on the identification of appropriate data to use as external controls for future trials. We perform a comprehensive analysis assessing candidate sources of external data and comparing clinical trial and real-world datasets in newly diagnosed glioblastoma.

Methods

Individual patient-level data (PLD) from several clinical trials, a large academic institutional database and a registry (National Cancer Database) were used for analysis of patients receiving standard of care radiation with concurrent and adjuvant temozolomide. Data summaries from randomized trials 2012-2022 were analyzed to account for trials without available PLD. Multivariable modeli

SUBMITTER: Rahman R 

PROVIDER: S-EPMC12309709 | biostudies-literature | 2025 Jul

REPOSITORIES: biostudies-literature