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posted by ElMaestro  – Denmark, 2016-01-28 16:07 (2982 d 05:14 ago) – Posting: # 15880
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Hi all,

❝ According to information (in French) published yesterday by the French Agency, the first group received 2.5 mg per day, over 10 days.


This is a very interesting document.
In hindsight it must have been an extremely difficult decision towards the end of January 10, whether or not to stop the trial at that point. If the hospitalisation was due to the drug (drug product) or its dose, and this is a judgement made by the investigator or/and attending medic, then one can argue the trial could have been stopped immediately. With this being a fim-trial,it has to be enormously difficult to make that judgement in spite of all sorts of preclin/nonclin results, computer modeling, IMPD's etc. How can any person possibly know?
Here the trial was continued with the rest of subjects in cohort 5 dosed the day after hospitalisation of one subject from this cohort. I imagine the decision to continue after January 10 (whether actively taken or passively) will be challenged regulatorily, medically and legally in the aftermath of all this. It would not surprise me if EU regulators will update rules for sequential vs. serial dosing in fim-trials as well as rules for premature termination.

I am not much for the benefit of hindsight and I do not wish to point fingers. I am not saying anyone did anything wrong and I am not implying that any rules or principles relating to dir. 2001/20, ICH E6 or the Helsinki Decl. have not been observed. Hospitalisation of the other subjects in the group could have been the outcome as well even if they had not been dosed on January 11.

Pass or fail!
ElMaestro

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