Saturday, September 24, 2022 1:20:35 PM
A crossover design was innovative?
It has been very common for these type trials long before this one started.
BTW, and exemplary design would have seen that the only approved DC vaccine had run 2 trials with PFS primary endpoint and OS secondary. Though the OS gold standard was a success, the PFS primary endpoint failed. The FDA told them to try again and they ran a trial with OS as the primary endpoint Despite crossover it worked and it was approved.
It has been very common for these type trials long before this one started.
BTW, and exemplary design would have seen that the only approved DC vaccine had run 2 trials with PFS primary endpoint and OS secondary. Though the OS gold standard was a success, the PFS primary endpoint failed. The FDA told them to try again and they ran a trial with OS as the primary endpoint Despite crossover it worked and it was approved.
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