NorthWest Biotherapeutics Inc (NWBO)

[manibiotech]

As usual wrong again:

From chatGPT:

“Yes — under the MHRA’s recent guidance (May 2025), external control arms (ECAs) are explicitly considered a use of Real-World Data (RWD) and the evidence generated from them qualifies as Real-World Evidence (RWE).

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📌 Key points from the MHRA guidelines:

✅ External control arms use RWD as a comparator group instead of a concurrent randomized control group.
✅ They can be constructed from:
• Historical clinical trial data
• Registries
• Electronic health records (EHRs)
• Administrative or insurance claims data
• Other observational datasets

✅ ECAs are a subtype of RWD study, where the control group comes from real-world sources instead of being randomized within the trial.
✅ When properly designed, ECA-based studies can support regulatory decisions — but the MHRA guidance emphasizes:
• Ensuring data quality (accuracy, completeness, traceability)
• Minimizing bias (e.g., through careful matching, statistical adjustment)
• Using pre-specified protocols reviewed by regulators.

✅ The MHRA draft guideline explicitly calls out ECAs as a legitimate approach in rare diseases, oncology, or settings where randomization is unethical or infeasible, provided the RWD source is robust.”

https://www.gov.uk/government/consultations/mhra-draft-guideline-on-the-use-of-external-control-arms-based-on-real-world-data-to-support-regulatory-decisions

https://assets.publishing.service.gov.uk/media/6825bab1a4c1a40fde4e63e5/Draft_MHRA_Guideline_on_Studies_with_RWD_ECA_May2025.pdf?utm_source=chatgpt.com

Only glitch is that they mention patient level data matching in their guidance .