Bioequivalence and Bioavailability Forum

Hi wienui,

❝ Should I understand that you think these kinds of studies "performed in CRO belong to the pharmaceutical Company" should be blocked and not accepted due to the high risk of COI and the possibility of manipulating the studies' outcomes.

❝ Is there any guidance, or literature on which we can rely on it to regulate this issue?

❝ Please kindly express your opinion clearly and frankly, it will help a lot.

I think I see your point, but I think it is asking too much in practice. Claiming that an existing relationship between Sponsor and CRO implies a high risk is a postulate, but I must emphasize that I agree to some extent. There is just no good alternative, is there? It may be impractical if we require that CROs can't be owned by the Sponsor.
a. I do not know of any guidance that really helps directly here but there are plenty clauses in ICH E6r2 that could be used on interpretation. If you think a COI exists and it will bias the outcome, then something like §2.5 or §2.13 might come in handy.
b. We need to bear in mind that many originators still have clinical departments that act as the company's own CRO (the only real difference being it may be called a division rather than a CRO). Would we also enforce a COI concern over those clinical departments? Why? Why not?
c. Defining what a "relation" is, and what is means to be "owned" etc is a legal mess. This is the playground of lawyers. I am sure that if we were to make an amendment in a guideline to the effect of "CROs cannot be owned by Sponsors" or whatever wording we use then I am sure it would change very little as CROs in question would just change the corporate setup to escape the issue.