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CLRM-12. HYBRID DESIGNS FOR USING EXTERNAL CONTROLS IN PHASE 3 GLIOBLASTOMA TRIALS

While recent Phase 3 glioblastoma (GBM) trials have failed to establish novel therapies, they potentially provide a high-quality source of external control patients treated with temozolomide. We consider hybrid two-stage adaptive designs that leverage these external controls to safely accelerate Pha...

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Detalles Bibliográficos
Autores principales: Polley, Mei-Yin, Schwartz, Daniel, Dignam, James
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Oxford University Press 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8453812/
http://dx.doi.org/10.1093/noajnl/vdab112.011