Who's running this study?

I just received an interesting article from a colleague:
http://www.tampabay.com/news/business/article463686.ece
The article discusses a clinical research unit in Florida where the PI oversight isn't exactly verifiable. This is always an issue for us as monitors, especially when the Dr. practices from one location and the study is conducted in another. I apply extra scrutiny in this case to ensure everything is in order and that the data isn't "too perfect" (do the subjects even exist? qualify? are they being followed properly as per protocol?, etc.)

As a monitor, I always like to have the sponsor pin down (before conduct begins) exactly which actions can be delegated (lab draws, EKG, etc) and which actions must be reserved for the PI or medically licensed personnel. In many studies, the assessment of Inclusion/Exclusion Criteria, Physical Exams, Dose escalations/de-escalations, and Lab/safety reviews are responsibilities that must be reserved for the physician. It is best if this is written in a statement on the Delegation of Authority Log but I take what I can get and always include this as a topic at site selection and initiation visits.

I always prefer to work with sites where the PI is highly involved but as monitors we don't always get that choice and the quality of the data can suffer. However, I recently worked with a site that enrolled almost 30 subjects in one month. They were the highest enroller and the numbers shocked everyone -- I immediately suspected that the PI may not have been very involved in the conduct due to the volume and time commitment that would require. The site had been initiated at the IM so by the time I had my first visit, they had enrolled over 10 subjects in this 7 week study. I conducted 4 routine monitoring visits over the 2 months and even brought co-monitors with me to handle the volume and "sniff out the deficiencies". At each visit the PI was available and very informed about his subjects and was constantly asking me to go back to the sponsor for clarifications on the protocol and to discuss changes he witnessed in his patient's lab values. My instincts were good but the reality is this PI was also very good and very involved in the oversight and conduct of the trial so I had nothing to worry about after all. The site was organized, fast at CRF entry/query resolution, and thorough. I would work with the site again in a heartbeat. That just goes to show that you don't always have to compromise quality when you have quantity.

On the other hand, I had a few other high enrollers in this study where PI oversight would have gone a long way to improving conduct. So the takeaway here is be especially wary when the PI is MIA and you have an over-zealous coordinators who always reassures you that "it's fine" ,"I'm handling it", "oh really, I didn't realize the protocol meant it that way..." and other red flag statements. Make sure the PI is available to meet with you at every visit. If you have had 2 visits in a row where the PI isn't around, escalate it to your lead CRA or the sponsor or refer to your SOPs. When an investigator signs a 1572, that is a legal contract that they agree to personally oversee the conduct of the trial. If you aren't satisfied that this is happening, document it in your report and follow-up via phone or meet with the PI to discuss your concerns. It is an uncomfortable conversation but that is one of your responsibilities as a monitor. I know from experience that this conversation is easier to have in the beginning rather than at the last visit before data lock, or when it is time to sign off on the casebook, or even after a (gulp) sponsor or FDA audit.