Bioequivalence and Bioavailability Forum

Hi Hötzi,

happy new year.

❝ THX for your summary. I was much too naïve. What a nightmare for inspectors!

Actually I don't think anything is naïve.
I think it is an area where inspectors can do very little and where the need for doing something is pronounced.

So I welcome any and all discussion and I'd be very happy to hear suggestions how to fix things so that it is possible to safeguard against cross-participation. I believe at the moment there is next to no prospects for doing anything with the system (like national data protection laws), and software providers who program and maintain the databases are not too keen on entering a discussion of the functionality at their end. Can something be done then?

I have been thinking a lot about it, but as you know my walnut-sized brain is much better at creating trouble than solving it, so I have only drawn a blank. I believe many regulators would appreciate dialogue and suggestions too. I think some of them are a bit frustrated about the limited options.

I was in Ahmedabad in July 2019, right after a volunteer had lost his life after being sent home from a BE trial. During lunches, dinners, breakfasts, breaks, in the hotel lobby at the Courtyard and Hyatt Vastrapur everyone seemed be discussing whether the guy had been crossparticipating. There was a lot of speculation in the air. Noone could get info on which trial he had participated in, the nature of the study drug, or who the sponsor was. The CRO's name was made public. I had brief dialogue with EU regulators about it - the consensus was that in the absence of proof that the death related to a dossier submitted in EU, no EU regulators could take any action. It makes lot of sense, technically and formally. But it is worrying as hell that this is how it works.
I asked if an EU regulator could ask the CRO if the person who died had participated in an EU trial (and when, relative to the time of death etc). As far as I understood, no CRO was obliged to answer a question like that. Again this quickly becomes a legal discussion whe outcome has to do with the industry protecting itself rather than a discussion of the protection of the trials subjects, present as well as future.
It was hinted to me that no regulator of e.g. the inspectors working group etc can ask such a question of behalf of others. It can perhaps be asked as a purely national matter, but then 20 regulators may need to ask and it is still doubtful if the CRO is under obligation to answer The overarching role of EMA only goes so far.

§2.3: The rights, safety, and well-being of the trial subjects are the most important considerations and should prevail over interests of science and society.