Failed study [Study As­sess­ment]

posted by Helmut Homepage – Vienna, Austria, 2021-04-26 22:33 (9 d 01:16 ago) – Posting: # 22328
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Hi mittyri,

» 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?

Yep. To quote myself:

»[…] we cannot distinguish between lack of compliance (the subject didn’t take the drug), a product failure, and a subject-by-formulation interaction (the subject belongs to a subpopulation).«


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