Study Rules

Just a question for those who have participated in a study before or know of anyone who has. I'm currently enrolled in a study (study drug PF-00547659), and am reading through the consent form. One section has me pretty confused.

It says "If you choose to be in this study, your participation will be for approximately 43 months. During this time, there will be a 19 month active treatment period, followed by 6 months of on site follow up. After this, you will be contacted every 6 months by telephone for 18 months. The on-site and telephone contacts make up a total of 24 months follow up period. The purpose of the 24 month follow up period is to monitor how you're feeling and continue to learn more about the safety of the drug".

Now, all I basically get from this, is I get treatment for 19 months. If this drug works great, puts me in remission, they take me off it after that treatment period and I'm pretty much left on my own. Im sorry, but is that not INSANE!? Why on earth would they want to suddenly stop giving us a medication if it's working? I'm so bothered by this. I'm already 12 weeks in (no effects yet, but I get the therapeutic dose on Monday), and I almost don't want to continue.

My disease is so bad I can't work or pretty much do anything right now, so something has to be done. But a temporary fix with a substance that isn't approved is not the route I want to go. I'm in Canada, and Vedolizumab won't be available here for probably another 6 months or so. Do I wait?

Also, during the 12 week's I've so far been in the study, I could have been getting Placebo or 4 different doses. I won't ever find out what those doses are either. That greatly affects my decision on weather or not I'd like to continue. If I'm currently getting a higher dose, and have seen no results, I'd rather not go into the extension study. But if I'm getting placebo or a low dose, there may still be hope (for a short 19 months at least).

Sorry for the long post that's all over the place. Really bothered right now. At the beginning of the study I even asked the nurse running it, "what happens when the studies over, do they continue to give it to me until its available to the public?" and she said yes. Clearly thats not the case according to the consent form.

Have you been getting the drug for the 12 weeks that you have been in the study or are they starting it on Monday, I'm a little confused.

And if you have been getting the drug for this whole time is it helping at all?

Are you willing to continue just to help other UC'ers who will benefit from this study?
I probably would not if it was causing me unemployment, financial distress and a generally bad life.

Write a letter to the study head and ask if you will have access to the drug after the 19 months if it proves to be good for UC.

Studies like this are bad for at least 1/3 of participants who get the placebo.
Imagine if you had life-threatening cancer and got the placebo.
Some studies end early because of this to give all participants treatment because it would be ethically wrong for people to die. But UC does not kill us….just feels that way.

I think they do it because they do not yet know the safety profile of the drug they are giving you so to keep all other factors constant, they give everyone the drug for the same amount of time. You never know, the drug might help with UC and then give you something else that might be dangerous. It's a difficult situation to be in for sure, but it is a new drug they know nothing about so that's why I think they try to err on the side of caution.

Studies like these are often designed such that at the endpoint of the original treatment period, if you were in the placebo group you can request to be switched into the treatment group. If I were you I would certainly ask about that.

Regarding not getting it anymore after 19 months... that is a long time into the future to be playing the what if game. Since you're talking about vedolizumab's approval date, I assume that you have tried everything else that is currently on the market in Canada. Why not stay in the study for 6 months, which should be adequate time to see if you're experiencing an improvement on the study drug, and if it isn't helping you, you can drop out and try vedolizumab?

Your participation in a clinical trial is completely voluntary and you can quit at any time. Sometimes I feel like that isn't communicated clearly enough to participants. If vedolizumab comes on the market and you feel that you would be better off trying it than staying in the study, you would be completely within your rights to do so.