I’m not sure where you’re getting your ideas about not allowing comparisons to Historical Controls (HC), but you’re wrong. Regulatory agencies, including the FDA, allow use of HC in situations where it’s a rare disease with little or no approved treatments that extend beyond the SOC, when the disease course is highly predictable and the treatment is showing dramatic results in comparison, where the endpoints are easily Objective (OS) and the impact of variables associated with treatment and baseline are well established...i.e. there’s plenty of data out there from other trials as well as real life data.
You have every right to be nervous about all of this but your seemingly indignant dismissal of allowing comparisons to Historical Controls isn’t being objective at all in my opinion.
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