No More Poop!

After 7 long months of screening patients for our C. diff study, I finally got the email that I've been waiting for:

Dear Sites,

Good News!

Optimer has decided to end enrollment for OPT 80-004!

IVRS will be deactivated for ALL sites at 4PM EST tomorrow (11 November 2009).

You will also receive an official site specific letter via courier to be filed in your regulatory Binder.

If you have any questions, please let your CRA know.

Kind Regards,

The 004 team

That's right! No more playing with poop samples!

Ok, let me explain a little about this study. It is a clinical trial that is testing a new drug against one of the current drugs used to treat Clostridium difficile infections. C. diff is a bacteria that infects your intestines, fights with the good bacteria in your digestive system for colonization, and causes you to have diarrhea and other symptoms. It is a fairly common disease and everyday, patients with C. diff symptoms have stool samples sent to the microbiology lab for testing and subsequent treatment.

It is my job to go down to the micro lab daily and test these samples with our own test kit provided by the study company (the micro lab probably knows me as the "poop girl" by now). If the patient tests positive, I have to look into their medical history to see if they qualify for the study. There is a HUGE laundry list of inclusion/exclusion criteria that very few meet. If they do meet them, I and one of the physicians approach the person and ask if they want to be part of a research study. Medication is then administered to the patient, specimen samples are collected, and I follow them throughout the study and fill out a bunch of paperwork about them and their progress.

Just to let you know how frustrating this study is: I screened ~450 patients. After all that poop testing and patient screening, only ONE patient was enrolled. SO much work and effort was put into trying to track down these dang patients and find ones that met all of the criteria! In fact, recruiting patients was so hard that they called all the site coordinators together to Las Vegas in August to discuss better recruitment methods.

Screening patients for this study was ridiculously tedious, frustrating, and annoying, mostly because of how much of a waste of time it was, considering the patient screened to enrolled ratio. I have been waiting for the day that the research company would tell us to stop enrolling patients and seriously had doubts that the email would ever come. I didn't even know how to react when I saw that email in my inbox today!

I used to be kind of embarassed to tell people I work with poop samples for a job, but towards the end of the study, I kind of embraced it and even made jokes about it. I can't say I'll miss the screening patients part of it, but the study itself was pretty cool and the perks were even better (business trips and free lunches all the time!).

I can't guarantee I'll be done with poop forever, as I'm sure they will be starting up more studies after they evaluate the data collected from the current one, but it is a welcome relief to get a break from that for now.

Next up for me, work in the burn unit with shock therapy treatment and an H1N1 study collecting blood samples from swine flu patients. Yay infectious diseases!