That hasn't been designed with the plan for a surrogate endpoint.
There are papers on the use of real world data AFTER accelerated approval, talking about the pros and cons and feasibility.
So maybe that's a potential. But that's for the confirmatory trial, not the initial.
Use your head people, come on, how would retrospective real world data be used? It would create the same statistics issues as post hoc analysis because that is what it is!
2024 Here we go again., page-205
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