’Some’ should read the GL (and again, and again) [Study As­sess­ment]

posted by Helmut Homepage – Vienna, Austria, 2019-07-27 13:48  – Posting: # 20451
Views: 1,041

Hi Datacollector,

» […] a well regarded EU regulatory agency has raised objections on public health grounds. Treatment by period interaction has been mentioned. I can't see how that could arise given that the design of the study is fine and assuming there was no major issue in the conduct of the study. I can only infer that the agency suspects that the study has not been executed correctly …

OK, then the agency should trigger an inspection1 rather than just ‘suspect’ sumfink. Again: Statistics2 cannot help. BTW, it is yet another – all too common – misconception that the p-value gives the prob­ability that the Null-hypothesis is true.

» … but is not prepared to say so in black and white.

Well, they are happy to speculate in black and white. As I wrote before, only a failure in randomization can be assessed in an inspection. Everything else: No way.

» Have you encountered this kind of response?

Yes. By the German BfArM three days (‼) ago. :thumb down:

Potential serious risk to public health not already raised by the RMS as major objection.
However, regarding ████, serious concerns on the results from BE-study ████ remain.




  1. Though I don’t see a clear reason in “Guidance on triggers for inspections of bioequivalence trials: Quick scan”.
  2. Even raising the question is some kind of double moral standards. We are not allowed to exclude anything based on statistics alone (not even reanalyse a sample). Quod licet Iovi, non licet bovi?

Cheers,
Helmut Schütz
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