Bootstrapping BE: Desultory thoughts [Study As­sess­ment]

posted by ElMaestro  – Denmark, 2021-07-09 18:29 (1109 d 10:11 ago) – Posting: # 22466
Views: 4,003

Hi Hötzi,

❝ Oh dear! Any details?

Read here.

"The Applicant should demonstrate that the consumer risk is not inflated above 5% with the proposed design and alpha expenditure rule, taking into account that simulations are not considered sufficiently robust and analytical solutions are preferred."


❝ Yep. Another issue are ‘outliers’ like in my example. Does it make sense to assume to face them in the pivotal as well? I hope not. Then what? Drop them from the pilot data and bootstrap that?

If you believe an observation is an outlier, for one reason or another, probably it does not make sense to include that observation in the planning. Ot at last this sounds like a healthy argument. On the other hand if you do take the outliers into consideration for the subsequent steps then often the sample size just gets larger.
At any rate, that aberrant value -whether you call it an outlier or not- is more or less what causes the residual to have a bonkers distribution. There may be several of them in the worst case. And then of course there's the issue with a positive and negative residual of equal magnitude subject-wise for a 222BE design. This is more of a triviality-by-design. When it rains it pours. :-)

Pass or fail!

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