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Re: biosectinvestor post# 392772

Sunday, 08/01/2021 3:32:20 PM

Sunday, August 01, 2021 3:32:20 PM

Post# of 726264

What we do know is they did 1) review for safety only, and then at some point 2) they did a blinded review for the paper.



Yes... and in fact, the blinded review was also specified in the protocol:

In addition to the planned interim analyses for the primary outcome, a sample
size re-estimation will be performed after 80% of the 348 patients have been
randomized. An independent statistician (IS) will be provided a dataset with all
available primary outcomes (i.e., times to progression, death, or censoring) for
the randomized cohort, without treatment group assignments. The IS will
calculate the Kaplan-Meier curve for the combined randomized cohort (DCVax-
L-treated and placebo treated patients). The median time to PFS (M) will be
estimated from this curve. The IS will use M as the assumed median for the
placebo group. The IS will then calculate a sample size assuming a median PFS
of M for the placebo group, and the same hazard ratio, Type I error rate and
power used in the original sample size calculation.



And it's obviously from this review that the blinded blended data came that was the basis for the JTM article from 2018.
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