Bioequivalence and Bioavailability Forum

hi nobody,

❝ Experience in humans before this trial according to protocol: zero, null, niente.

That’s why such studies are called First-in-man (or lately more “politically correct” First-in-human), right?

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:

• no explanation was found so far regarding what happened...
  
• no observation regarding the way an authorisation was granted to Biotrial to run Phase I studies (by the way, they don't recommend to suspend that authorisation)
  
• the favourable opinion of the Ethics Committee and the authorisation by ANSM followed the French laws and regulations
  
• some discussion on administrative aspects, some bullshit here and there.

❝ The decision to continue cohort 5 on Jan 11^th 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:

• the subject had some transient, non-specific and non-worrying signs from 9 AM on the Sunday;
  
• after he woke up from an afternoon nap, the other subjects called a staff member around 18:30 (no detail given on the symptoms);
  
• the MD on night duty examined him and called a subinvestigator. The decision to transfer the subject to the hospital was taken after further examinations and phone discussions. The subject was then immediately transferred;
  
• at 20:40, the MD on night duty informed by phone the MD who was to administer the IMP on the next morning, that the subject had been hospitalised;
  
• Monday at 07:55, the MD on night duty gave feed-back to the second MD, and informed him that he had refused the transfer of the subject from the hospital back to Biotrial during the night (no reason given in the report);
  
• the remaining subjects were dosed;
  
• then around 9 AM, a MD called the hospital to get some news regarding the status of the subject who had been hospitalised... So apparently, after dosing the other subjects.

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.

works as expected, huh?

That's what I meant with "cover up" from the very beginning. Drop responsibility somewhere else, protocol might be fu** up, but in NO WAY the authorities were involved or could have stopped this.. NOOOOOWAAAAYYY

Dear ElMaestro,

❝ PS: Hey where did 'strikethrough' letters suddenly go?!? Hötzi, you naughty boy, have you been messing up the board again? *sigh* What shall we do with you?

Seems you have re-discovered the strike-through letters .

To demystify this for others:
durchgestrichen is coded with the tag [d].

Sometimes RTFM helps .