NorthWest Biotherapeutics Inc (NWBO)

[Lykiri]

Randomized trials can selectively enroll. But to then compare against historical norms is an issue. Trials DESIGNED to be compared to historical norms will be DESIGNED to have matched patients.

At least that is what Dr Pazdur says.

exwannabe,

I don't think it's an issue for the FDA. Here's a good example:
SNO 2020 Think Tank on Neuro-Oncology Clinical Trials-November 6, 2020.
Slide at 6:46:03

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)