Should clinical monitors have expertise in specific therapeutic areas before conducting a trial?  In my experience, it truly depends on the client.

Pharma sponsors are very invested in their compound or device and want to be sure that monitors know exactly what they are doing.  However, many don’t understand the value and array of cross-over skills a monitor brings to the table or the additional training they will receive on this therapeutic area/protocol.

In my experience, it is possible to apply practical experience in one therapeutic area to another.  Especially if a monitor has a scientific background, they are able to connect the dots from disease state to disease state.

Case in point, I have worked on a trial for lupus nephritis testing Rituximab, an intravenous drug used to treat rheumatoid arthritis and B-cell non-Hodgkin’s lymphoma. I know the drugs’ mechanism of action, which I can transfer to another trial in a different therapeutic area.  Lupus nephritis, as the name implies, has to do with how lupus affects the kidneys; I am able to transfer my knowledge of this kidney disease to trials for areas such as hemodialysis or renal cell cancer.

I do agree that there are different complexities to a trial and if a monitor has typically worked on a fairly simple trial, we wouldn’t necessarily assign them to a very difficult trial.  For example, if a monitor worked primarily on out-patient studies that involve low-risk diseases (i.e., skin rashes, eye infections, hemorrhoids), we wouldn’t assign them to an in-patient pancreatic cancer study, with no prior experience.  The monitor would need to “work their way up” to this type of trial.