Rules acc. to Health Canada [Outliers]

posted by Shuanghe  – Spain, 2019-02-06 11:48 (903 d 08:45 ago) – Posting: # 19880
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Dear all,

On slightly related issue. Canadian guideline says max 5% outliers can be removed and one criterion for outlier test is studentised residual > 3.

I had an incidence in a pilot study where there are more than 5% subjects having studentised residual > 3. Since it's a pilot, it doesn't matter too much but in the protocols of pivotal studies I made it very clear that if this happens, the 5% subjects to be removed will be chosen by the magnitude of the residuals: only remove those with highest residual (in absolute value, e.g., those with residual -7 will be removed before those with residual 5). For the rest of those subjects, even though they are identified as outlier, they will be included in the BE evaluation, in accordance with guidance's 5% rule. Unfortunately (or fortunately), it never happens to my pivotal studies so I have no idea if Canadian agency is really ok with this.

Do any of you have such experience?

All the best,
Shuanghe

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