Repetitive testing? [Outliers]

posted by Helmut Homepage – Vienna, Austria, 2014-07-10 17:42 (3256 d 00:07 ago) – Posting: # 13256
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Hi Pankaj,

❝ […] the data shows only one outlier subject by Lund's procedure in 2X2 crossover design study. After removing this outlier subject, when the data is again run for Lund’s test, another outlier subject is observed.

❝ Can we perform Lund’s test in such repetative manner to remove outliers from the data?

Please read the original publication.* IMHO, repetitive testing is statistically doubtful (politely speaking). We once faced a similar case 15+ years back when two outliers were detected and the French agency ‘discovered’ yet another one in the reduced data set. Agencies can do almost everything. I would not do it voluntarily. ;-)

Some remarks:

❝ Is it acceptable by usfda regulatory subject to redosing study with multiple outlier subjects with control subjects)?

In principle, yes. However, the FDA has a strict policy against removal of outliers in non-replicated studies and accepts re-dosing only if the procedure was stated in the protocol. I would not recommend performing a re-dosing study without controled correspondence with CDER/OGD’s review staff (see this recent draft guidance; lines 644–647).

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