coordinators aren't going to like this at all.

As I was reading over some CFRs today (that is my life, unfortunately), I came across something of interest in the financial disclosure section (21 CFR part 54, for those of you who are interested). It mentions that financial disclosure is required for any investigator who contributes or evaluates data in a clinical trial. Now that could be loosely interpreted to be any physician (or health care provider) investigator listed on the 1572, but if one thinks about it...coordinators often play a vital role in contributing study data. Take for example hypertension or weight loss trials. Study coordinators will take blood pressure or weight according to a "standardized" system established by the study sponsor. The sponsor is doing its part by standardizing both the collection method as well as the training, but how is the sponsor ensuring that the coordinators providing this essential data are not financial invested in the results? I know it's not a terribly likely scenario, but it is worth considering, especially since there is so much information available for public use today.

A louche coordinator with a hidden financial stake in a study result could very easily "modify" results to help push data that will benefit him/her in the long run. Oh, and let's not forget that according to 21 CFR part 54, financial disclosure also applies to the spouses/dependent children of those investigators providing it. That nugget of information only complicates matters. Given that this situation is probably not going to happen, I think that requiring financial disclosure by coordinators would be an effective mechanism to ensury validity of data collected by coordinators because we all know that the coordinator plays a much larger role in clinical trials than I think the FDA would like to admit.

So how would all this go down? I would consider adding coordinators universally to the 1572 for all studies where coordinator assessments are part of the primary or secondary endpoints of the trial as described in the protocol. I think this would provide sufficient protection for the sponsor that their trial is being conducted appropriately with no financial influences at any level. Additionally box 6 of the 1572 asks for the names of all subinvestigators assisting the principal investigator in the conduct of the trial. You could say that subinvestigators are only licensed health care providers, but one could very easily interpret this to mean that coordinators are investigators for some studies and they are indeed assiting the PI, so they should be listed on the 1572. Granted this would created additional headaches for sites such as the need to acquire FDF part Bs at the end of studies and that might be difficult if coordinators leave the site, but I think the overall benefit to the site/sponsor would far outweigh those minor annoyances.

I'm not terribly optimistic that this trend would catch on because there doesn't seem to be much formal guidance on who signs FDFs other than the loose language in 21 CFR part 54, but with the FDA's apparent trend toward more regulatory enforcement (as well as the growing public microscope on clinical trial results), it might not be a bad idea to consider it.

By the way, check out EyeonFDA today. Good piece on healthcare reform.