Failed study [Study As­sess­ment]

posted by Helmut Homepage – Vienna, Austria, 2021-04-27 02:33 (1037 d 01:03 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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