ONTY: OK so he was referring to the total alpha of 0.025. Is that one-sided or two-sided?
I have always thought it was 2 sided, and this CC should end that discussion. But never knew the exact reason why the FDA imposed it as a requirement for the SPA.
Is this always the case, if one wants a SPA on a single trial the FDA wants to see a lower P?
Or was this partially because the P2 data was statistically bad (in combo with the single trial)?
OK so he was referring to the total alpha of 0.025. Is that one-sided or two-sided?
At a conference prior to 1st interim announcement, Kirkman used the phrase to describe trial design as "at the .025 level". Back then I asked the same question on the IV board you are asking now. I got a succinct reply from Nono that it was 1 sided. I have not been able to confirm this independently. But I will say Nono has been a pretty reliable source of info on START.
Perhaps this is a German pharma thing. A Bayer presentation on regorafenib in last line mCRC (CORRECT trial) had a slide showing trial design with the statement "1 sided overall alpha = 0.025"
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