Tuesday, January 05, 2021 2:57:46 PM
you are basically saying that unblinded trials should never be allowed. If that were the case GBM patients wouldn't be living longer using optune now.
The key phrase is 'a priori'...that's why the SAPa nd protocol are prespecified...that's what prevents cherry picking even in an unblinded context. For sure some can creep in anyway but it would take an extreme amount to get those two KM curves overlapped. You'd need a lot of MDs in a lot of different centers that were complicit.
"unreasonably forecasting/padding long-term survival stats"
There was no issue with this. They were using standard KM analysis. They simply don't have long enough follow up to say anything meaningful about long term survival and it was immoral of them to quote that 5-year KM stat.
The key phrase is 'a priori'...that's why the SAPa nd protocol are prespecified...that's what prevents cherry picking even in an unblinded context. For sure some can creep in anyway but it would take an extreme amount to get those two KM curves overlapped. You'd need a lot of MDs in a lot of different centers that were complicit.
"unreasonably forecasting/padding long-term survival stats"
There was no issue with this. They were using standard KM analysis. They simply don't have long enough follow up to say anything meaningful about long term survival and it was immoral of them to quote that 5-year KM stat.
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