I was originally going to add this to my post on my first infusion, but I figured not everyone would want to read my personal experience. These are my worries about going on a clinical trial and how I assayed those fears.
I was definitely a clinical trial hater. Why would I want to put something in my body that isn't even FDA approved? Who knew if I was going to get some awful side effect? I thought I was going to be treated as a number and a lab rat to the pharmaceutical companies.
Here is a list of my fears, and how I got past them:
1. I'm just a number to the company funding this project, how do I know it's in my best interest?
-This was the point where I knew I had to trust my doctor. He gave me his honest opinion that this was my best option, I did my own research, and it seems like this may actually work.-
2. If this isn't FDA approved, how do I know this won't give me really awful side effects?
-I was totally freaked out by the thought of getting cancer from this medicine. My doctor explained the process of clinical trials. First, they go through Phase 1 in which they inject the drug into humans and see whether or not they actually stay in the blood and will do what they are meant to do. If it actually works, it goes to Phase 2. There, they test for side effects. They see if anything awful crops up. Although I wondered about long-term side effects, what research has shown us so far, is that side effects in medicine are not very different in 20 years than they are in the first 5. Finally, if they pass these two phases, they make it to Phase 3. Here is where they see if the drug actually helps the patients. The patients fill out paperwork and possibly a journal which gives a CDAI (Crohn's disease Activity Index). A certain dosage is decided, either one dose or something else determined by the company, and administered to the patients. Depending on the time frame in which the drug is again administered, a new CDAI is taken to see if the quality of life is actually improving. They are testing to see if the drug can bring a patient to remission. A part of Phase 3 which only occurs if patients' CDAI is lowered is an extended Phase 3 which sees if the drug can keep a patient in remission. If the drug isn't quite FDA approved, but the company decides to keep it in study, the drug enters a Phase 4 which could last up to 4 years or longer.
Basically - a drug has to be very safe in order ot enter Phase 3.-
3. It doesn't really fit in my schedule, can that be changed?
-Unfortunately (Actually... fortunately), clinical trials are very strictly monitered by the FDA. They have to be extremely regimented or people can go to jail. You have to either make it work, or the clinical trial isn't your option. You have to decide if it's right for you.-
If you have any other questions or doubts about going on a clinical trial - send an e-mail or post a comment and I will help you the best I can!