What are the issues surrounding experimental procedures?
The video What are the issues surrounding experimental procedures? requires the Adobe Flash Player. You can download the latest version of Flash here.
You can also read the transcript of the video below.
Gregory Dolin, M.D., J.D. John M. Olin Fellow in Law
Oncofertility Consortium
Feinberg School of Medicine, Northwestern University
So, if a patient goes into an experimental procedure, there are certain things that he should know or she should know and expect, and usually those will be covered when they sign up for the procedure by the investigators and by the legal team. But there are really several issues. First, they do have to realize that in a lot of studies there are so called double-blind studies where you have a group of patients who are getting just the placebo and then the group of patients will get experimental treatment, or group of patients who’re getting the old treatment and the group that would get a new treatment so that you can then compare which treatment is more efficacious.
The second point that they should be aware is that even if they do end up in the experimental group, and, again, they won’t really know, but I mean if they do end up in the experimental group precisely because it's still at its experimental stages, there are absolutely no guarantees that that will be successful or that will be better than the old way of doing things. And, of course, a lot of patients wanna take the risk because they’ve already tried the old method and it failed to cure their problems or to alleviate their problems. But I think those are two really overriding issues at least on the treatment side, on the medical side.
On the legal side and, again, in some ways, it's state by state and some ways there are some sort of federal law involved but they at least should be aware that they may be waiving certain legal rights that they may have, and those will generally be outlined in the contract that they enter into with the investigator, with the clinic that is doing the studies. But they're slightly in a somewhat different territory than just going to the doctor’s office and getting what's generally known as a standard acceptable medical care.
And, of course, understand that a lot of people are willing to go through all that because that’s really their only option, having tried lots of other things, but those are the kind of the three issues that I think they should be aware that they may not be getting what they wanna be getting, that if they are getting what they wanna be getting, it may not be of any help or of very minor help, and that even if it is of help to the extent that there may be some side effects, some detrimental side effects, they may, depending on the local law, may be waiving certain rights for compensation or for remedies.
