Thursday, April 14, 2022 12:32:21 PM
To challenge effect size observed in the Phase 2b study and to explore use of an ECA as a viable comparator arm for the Phase 3 study, Medicenna recruited an eligibility matched control group for comparison against outcome of the Phase 2b study.
Subjects recruited in ECA were identified from patient registries at two major neurosurgery centers with access to GBM tumor tissue banks under IRB-approved protocols.
In order to avoid potential bias, Medicenna was blinded to the survival data throughout the project.
An expert group in regulatory statistics and real-word data (Acorn AI) was contracted to analyze the data employing propensity score weighting methodology to adjust for baseline differences in the 2 groups (i.e. MDNA55 versus ECA)
(source: SNO 2020 Think Tank on Neuro-Oncology Clinical Trials-November 6, 2020.)
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