Administrative inspection preliminary outcome [Off Topic]

posted by Ohlbe – France, 2016-02-05 00:30 (2974 d 16:30 ago) – Posting: # 15928
Views: 39,675

(edited by Ohlbe on 2016-02-05 16:23)

Dear all,

The interim report of the "Inspection générale des Affaires sociales" (IGAS, general inspectorate for social affairs) has been published today (in French). The IGAS is more of an administrative overarching inspection body, not specialists in clinical trials. However, their interim report occasionally refers to the interim report of the ANSM, the French competent authority.

To summarise:

❝ The decision to continue cohort 5 on Jan 11th was a tough one and IMHO, more than questionable.


IMHO that's indeed the most interesting part of the report (see from page 23, some chronology also on page 29). Basically:Biotrial apparently say that they expected the subject to come back from the hospital on Monday morning (well, in a way that's understandable if the hospital tried to transfer him back during the night), and that they never received a call from the hospital to inform them that he was worsening.

The IGAS investigations are still ongoing. The ANSM inspection report has apparently been sent to Biotrial for their response, with some requests for additional information. But in any case, it looks like none of the two inspections will identify the root cause of the accident.

Other investigations are still ongoing - including those of the judges assigned to the case. The cops have probably seized the remaining IMPs and sent them to a lab for analysis. Maybe we'll learn more from this.


Edit: Biotrial apparently claim that the subject had his first brain MRI on the Monday at 9 AM, i.e. after the other subjects were dosed at 8 AM, and that they got the information at 10 AM that he had had a stroke.

Regards
Ohlbe

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