The problem with clinical trials

[ConcernedInNY]

Heres the thing...if you get selected for the clinical trial....theres only a 50% chance you are even given the drug they are testing.

Is there a way around this?  I understand that since a particular drug is not FDA approved and due to lawsuits, etc etc., that this is the way things are done.

Cant they give a patient the drug out of compassion - like if we sign a waiver or something?  Or maybe hospitals have a cancer advocacy program where they fight to get patients these drugs?  There could be new drugs out there better than whats already approved and with this disease, women dont have the years to wait for FDA approval.

Im sure some of you have been through this or know someone who has been through this and Id sincerely appreciate it if you could offer some guidance or suggestions on how my family can proceed.

Thanks!

[sdp4314]

Maybe some facilities do it a bit differently.  My husband was in a clinical trial for renal cell cancer with many other patients and they all received the same medication.  The work on our part was to document everything in a log and turn it in.  As long as she meets the criteria, I don't see why they won't administer it.  I just don't understand--there are people fighting to live and why won't they just give 'em the chemo and see if it works or not.  There's always that hope that it could and/or will work!  

I am sorry about your mom.  I've been reading your posts and have always wanted to say something, but never did. My thoughts and prayers are with your mom, you and the family.  I know what it's like to feel like your hands are tied.  I also know what it's like to watch someone you love fighting to live.  I pray God gives you the strength to continue to be there for your mom.


Hugs from Texas,
Shawn

[shengirl]

I believe there is a law that requires patients who are end stage or have almost no other options, to be allowed to receive treatments that are still in trials. But the problem with this is that since it is still a trial treatment, no insurance company will cover it. And if you've looked at the cost of regular chemos and treatments, I hate to think the cost of an experimental drug.

[Barney22]

I think it depends entirely on the type of trial - the one I was on was a 50:50 random controlled one with 50% of us on a placebo.  As we weren't strictly speaking under treatment ie it was immediately after we had completed a chemo course (a drug to try to prevent recurrence was being tested) it didn't really mean we lost out if we were on the placebo as they had little information as to whether it would make a difference - do you see what I mean?  I think you need to look out for trials of a drug where they are simply testing different methods of delivery eg another one at my hospital gives random selection on whether you have the new drug via a 3-hour or a 1-hour IV infusion.  So, all patients get the same drug.  Others are testing a new drug against an existing one ie comparing outcomes but I don't think those are random controlled as you have to be told about possible side effects and those would be different?  Having probably been on the placebo I mentioned earlier I can ruefully sympathise with you on this.  They do try to apply true scientific principles in order to prevent ideas influencing facts but other issues intrude when they are looking at cancer - when patients drop out during the trial because of recurrence that may change the whole numbers quite quickly so what they are comparing changes also.  It is a really difficult area in cancer though.

[Barney22]

Sorry - I should have said I am in the UK and I believe the protocols are much the same for clinical trials pretty well all over the world - in order to have some sound scientific basis for any claims they make for drug efficacy.  I think the FDA issue is mainly about protecting patients and having covering insurance - we have something similar here.