i have a question pertaining to drug trials. do you think it is fair for a patient to have to stay with a trial [for 18 months or ever how long the trial is] if they are going downhill and it is obvious that they are getting the placebo or even if they are getting the drug and are still going downhill? there just is no way i would let my dh stay in a trial,if he was getting worse. do you have to stay in a trial for the duration,even if the outcome is bad? if so,no trials for us,out of the question. jav
jav, excellent question. I am not the person to answer because I chose no trials when I came here and discovered there were trials out there. Because my husband's dementia is EVENT driven he probably wouldn't be eligible for one anyway, but...
I think you need to ask yourself if he wouldn't have continued to get worse no matter what was going on. In some of the trials they require no other drugs. In some of them they require certain drugs but no changes during the trial. If the patient is already on one or more of the standard drugs, does the trial drug really make a difference? Right now, is there really anything better? For the most part the answer is no.
For a lot of the people here who are on trials, it is because it is the best thing they can think of that they can do. Maybe their LO will be the miracle. It is a gamble. And miracles do happen. But it isn't as if what is now standard procedure is actually good medicine because it stinks.
We have been assured by our physician that we can opt out of the study at any time. Indeed the consent form signed for the Elan study states that you are free to withdraw from the study at any time without giving a reason. Until something better comes along, what do we really have to lose and if something better does, then we will opt out of the study and try the new promise of hope. As Starling said" it's a gamble" and so sad in this case when it involves our lives.
jav, as Inge says, you can stop participating in any trial at any time, for any reason.
Also, many trials have more than one stage. Your spouse may be placebo during the first stage, but then go on what they call "open label" (that is, you know your spouse is getting the drug) during the next stage.
And some trials do not have a placebo group at all -- all patients get the drug.