failed study? [Study As­sess­ment]

posted by mittyri – Russia, 2021-04-26 21:01 (651 d 09:44 ago) – Posting: # 22326
Views: 1,898

Dear Ohlbe,

❝ In Europe, subject B could be excluded according to the EU BE guideline, but subject A could not as the period with all BLQ was after the test product. EU regulators will tell you that this might be due to your product and you can't exclude the data just because they don't suit you. In such a situation: you're screwed.

what is the proposed solution for such situation?
say the subject did not swallow the IMP (just for fun) and investigators missed that.
There's no way to prove this without direct subject's confession. Game over? The study failed?

Kind regards,

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