Regulatory Open Forum

Nancy, what a great question.  In the distant past I've dealt with the issue of employees of the Sponsor serving as PI and also as subjects, but of course today it's easy to see how this question would extend to CROs as well.

The CRO's interest is to get Sponsors to pay them to manage and monitor their studies.  The PI's interest is to get CROs to pay them to conduct the studies.  So I guess from that perspective, you could say their interests are perfectly aligned, lol.

As I'm sure you know, both the IND and IDE regs make provision for an organizations to use one or more of its own employees to conduct an investigation that it has initiated. I don't like it, but there it is. Probably it is well past time for the regs to accept the fact that very sponsors rarely field their own trials any more.  I haven't looked at the Financial Disclosure form lately, but I'm guessing it fails to account for this scenario?

I think the main stumbling block is in the monitoring. In this scenario, the monitor probably works directly for the PI, meaning they are not independent.  However, FDA has always been more flexible about independence than pretty much any RA or QA person I've ever known, so what that means from a regulatory standpoint, I can't say.  I can say that, if I were a Sponsor, I would have problems with it, and would want to arrange for an independent monitor.  On the other hand, some Sponsors might be more than happy with this arrangement. 

I was also just hit by the thunderbolt realization that these disclosures should really be part of informed consent, shouldn't they?

HI Julie.

That's an interesting point that you make regarding the inclusion of a statement in the IC form for the purpose of describing the relationship between the PI and the CRO.  However, I think that might be overthinking the issue a bit.  That is something that needs to be understood at the IRB and FDA and sponsor levels.  I really don't think it needs to be granularly included in the IC.  Think of it this way - many of the IC forms already extend to more than a dozen pages to obtain informed consent.  Now, reality is - speaking as someone who has a bit of IRB experience - I don't believe that anyone being presented with these documents truly "reads, comprehends and asks appropriate questions" after being informed that there is a potential clinical trial they might qualify for - especially if that trial could save their life or the life of a loved one.  Adding anything more into that document makes it less likely that any information is understood and questioned. 

To me - best way to handle this situation - insistence on an independent monitor for these sites.  Or, the sponsor monitors the site directly.

Nancy, what a great question.  In the distant past I've dealt with the issue of employees of the Sponsor serving as PI and also as subjects, but of course today it's easy to see how this question would extend to CROs as well.

The CRO's interest is to get Sponsors to pay them to manage and monitor their studies.  The PI's interest is to get CROs to pay them to conduct the studies.  So I guess from that perspective, you could say their interests are perfectly aligned, lol.

As I'm sure you know, both the IND and IDE regs make provision for an organizations to use one or more of its own employees to conduct an investigation that it has initiated. I don't like it, but there it is. Probably it is well past time for the regs to accept the fact that very sponsors rarely field their own trials any more.  I haven't looked at the Financial Disclosure form lately, but I'm guessing it fails to account for this scenario?

I think the main stumbling block is in the monitoring. In this scenario, the monitor probably works directly for the PI, meaning they are not independent.  However, FDA has always been more flexible about independence than pretty much any RA or QA person I've ever known, so what that means from a regulatory standpoint, I can't say.  I can say that, if I were a Sponsor, I would have problems with it, and would want to arrange for an independent monitor.  On the other hand, some Sponsors might be more than happy with this arrangement. 

I was also just hit by the thunderbolt realization that these disclosures should really be part of informed consent, shouldn't they?