Site Visitors

There are different types of research studies. There are nonfunded studies, federally funded studies, not-for-profit or nonprofit funded studies, and industry sponsored (both investigator initiated and company initiated) studies. I'm sure there are other types as well, but I haven't done those.

At this job, I work mostly with nonfunded studies, but we do have a few industry sponsored studies...and I am actually most familiar with those, since that's all I did for the 12 years I did psychiatric research.

When we do an industry sponsored study, the pharmaceutical or device company has to send out a couple of people to look us over and make sure we have what it takes to do the study. It's always seemed a little silly to me -- after all, this is a university medical center -- but I suppose they want to be certain that we really, really do have access to a lab, and ECG machines, and MRIs, and surgery suites, and a centrifuge, and surgery imaging...you get the picture. Before they give us any money, they have to be sure that we can do the study.

They also ask about a million questions about the credentials of the people who will work on the trial, the Institutional Review Board, the Scientific Committee screening process, how we plan to find people to participate, how many similar trials we've done...and on...and on.

That's what I did last Wednesday -- some folks from a Canadian company came and looked us over. And I got to give 'em the tour...which explains a lot about why my leg got so much worse last Thursday.

Usually they give us a list of what they want to see -- and often a peek through the door is sufficient -- but these folks wanted a thorough, indepth tour of several facilities, none of which they'd asked for in advance. They even OPENED the lab freezers to make sure there would be space for their stuff, noted the last inspection dates on the MRI machines, and asked for the imaging equipment to be demonstrated. I had to make some frantic phone calls, call in some favors, and eventually they did see most of what they wanted, although the ECG people did NOT allow us to tour. Which is typical for cardiology...they need to get over themselves, really.

At any rate, we're approved for this study now -- which means we have something else to offer our terminal head and neck cancer patients. This treatment won't cure them, but might make those last months easier...and doesn't look like it'll detract from quality of life...and might help someone else down the line if it works.

Not only that, but I get to take a trip to Toronto in early July for the start up meeting.