Bioequivalence and Bioavailability Forum

Hi wienui and all,

I think this is an excellent topic.
This is not so much discussion of what the current rules are but more about considerations that could make the rules better.

Clearly, one can speculate that a corporate link between sponsor and CRO could somehow bias the result.
I am not saying it does, but I certainly agree it could. That would depend on the details, and these details are completely in the dark in the sense that some of them could be matters that are outside the scope of any type of regulatory scrutiny incl. inspections.

In a wider sense, perhaps this isn't just about CRO vs Sponsor. In my ideal world the Sponsor would not pick the clinical site/CRO or bioanalytical site/CRO; these choices would be at the discretion of some independent party. In my ideal world, the Sponsor would not be trusted to appoint monitor but the need for and extent of monitoring would be dictated by an outside unbiased entity. In my ideal world, the name of the Sponsor would be blind to the assessor after the dossier were submitted. I am saying this for a reason. And so forth.

The theoretical feasibility for such ideas is low or nil, though. Perhaps because my ideas of the ideal world are not shared by anyone else but also be because the system just moves very slowly. A member of the forum mentioned how ideas aired at Crystal City in 2006 materialised only in 2022. Go figure... That's 16 years.
So, a lot of the discussion related to regulatory science is not just science. It is science given a system which happens to be somewhat inert.