Saturday, June 25, 2022 2:58:03 PM
There are several ways ECAs can try to address this.
As you say, patient level data on the ECA is best, NWBO has flat out stated they do not have that.
If everything fits into subgroups that are presented in the ECAs, they can adjust patient level data of the trial to match the ECA composite, They did perform this, but details are not disclosed.
Even with the above analysis, the problem is that not every variable fits into nice subgroups, and even when do not all trials disclosed the data,
The actual extent of resection is an obvious concern. The presentations have disclosed subgroups on "very little" or "more than very little". What they have zero data on "a modest amount" vs "a lot".
They cannot fix this.
People should actually read the paper by Pazdur et all on ECAs. It discloses why this is a problem.
but there are many others.
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