Research Question

I am doing similar research now, both pharma trials and device trials in head and neck cancer. I've previously done pharma trials in psychiatry and also worked in a federally funded center doing NIH trials (15 years experience in research at this point). In the cancer trials I am doing now, the doc actually does quite a lot, especially with the device studies, which has not been my experience in the past.

It is a lot of work, depending on the study. Sometimes the sponsor will loosen enrollment criteria if they are not getting patients fast enough, and every once in a while you can persuade them to take an exception, someone who doesn't quite fit criteria.

Since I work for a university, my paperwork is probably triple yours because I have to jump through the university hoops in addition to everything else!

This is my firsrt research project that he's done since I've started working there. The company sent me this huge binder with all the paperwork and such in it....plus all the boxes with the stuff for the pts who do the study. It was VERY overwhelming to find all the right places to put the stuff...I've never seen a filing system like this one..it had sub tabs! There were sections for the pharm company (and sub tabs for communication, forms....) a section for the study name group (and sub tabs) and a tab for the company thats running the study (and even MORE sub tabs)

The study is pretty neat, but we are still having a heck of a time getting qualified pts. The pts must be insulin naieve (sp?), A1c over 8.0 and so on and so forth. Most of our pts are either already on insulin, have a disqualifying heart problem, or the a1c isn't high enough.

We had one lady that was PERFECT for the study, but she didn't want to test her BS 8 times on the day before each appt (which are about monthly) and that was the ONLY reason she declined signing up. ARG! She ended up on the same insulin as the study used!

Well, I guess I'll have to come back to this thread more often!

Jules

You may be able to find patients by asking for referrals from some of the clinics in your area which serve fixed-income or low-income people. Since the study pays the MD, patients can get their study visit and medication free and maybe even a travel reimbursement...people who can't afford their medicine otherwise may really benefit from participation, depending on the study. And I could often persuade my docs to follow the most indigent cases for 3-6 months afterwards (and supply them with samples).

Those binders CAN be overwhelming! It's important to fill everything out as it happens, because if you wait it can be a nightmare (I am currently cleaning up one such nightmare -- the previous coordinator had not filled out any of her study books FOR A YEAR -- I just can't tell you how awful THAT has been!).