Bioequivalence and Bioavailability Forum

Alpha? [Power / Sample Size]

posted by ElMaestro  – Denmark, 2013-10-28 15:23 (4617 d 04:07 ago) – Posting: # 11794
Views: 9,485

Hi Hötzi,

❝ Hhm, why do you think so? IMHO, whatever we do here might only affect power. The pivotal study will stand on its own and doesn’t need any α-adjustment.

We're on the same page. Pilots and pivotals are traditionally stand-alone events. It gets a little tricky if applicants specify that a successful pilot must be accepted as a pivotal, which happens and is ok with some authorities. Success at the pilot sage is in itself rare though.
In such a situation alpha speculation may be relevant due to type I errors. I am fairly sure a reviewer would raise the point if a paper is submitted. Especially if it ends up in hands of people who have reviewed Potvin's paper and the sequelae.

Complete thread:

• “Ideal” sample size of a pilot study? Helmut 2013-10-27 14:15 
  • “Ideal” sample size of a pilot study? ElMaestro 2013-10-27 16:47
    • “Ideal” sample size for TSDs’ n1? Helmut 2013-10-27 18:27
      • “Ideal” sample size for TSDs’ n1? ElMaestro 2013-10-27 19:09
        • “Ideal” sample size for TSDs’ n1? Helmut 2013-10-27 19:19
    • Alpha? Helmut 2013-10-28 13:29
      • Alpha?ElMaestro 2013-10-28 14:23
        • Alpha? Helmut 2013-10-28 15:01
    • 12 = bad Helmut 2013-10-30 23:49