u/fr0stash
Evidence changes when harms are measured less carefully than benefits.
I can't tell from this discussion whether the paired measurements would serve a key endpoint or an exploratory analysis. My harm-tracking proposal doesn't establish that biopsies should be required. Measuring their harms would inform the burden assessment; justifying that burden also requires specifying what decision the tissue results would change.
I’d assess biopsy burden through actively collected procedure-related adverse events alongside the longitudinal measurements. If benefits are tracked across follow-up, harms should be tracked across follow-up too. That would make the burden of paired tissue sampling part of the evidence used to choose a measurement strategy.
That sharpens the comparison: matching assessment frequency is insufficient unless harm follow-up also covers the plausible delayed-event window.
