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What happens when a trial ends?

I am alive
Posts: 269
Joined: Jul 2012

Ok. This is probably a really stupid question - so glad this board is anonymous - but what happens if you are in a trial that is working for you and it ends? Are you just out of luck? I'm in a trial with two already FDA-approved drugs. But I guess the way this works is that their combination as a viable treatment has not been approved, and so therefore insurance would not cover use of the two drugs together until official approval? Is that right?
And what about other trials? What happens if you enjoy tremendous success with a drug that is being tested and the trial ends? Must you then give up on that drug and find another, and hope you live long enough to see the drug you really want wind it's way to FDA approval? Yikes.
Now some old hands at this might smile at my naïveté, knowing that all drugs have limited effectiveness. But, wading into the waters here, us newbies cling to the gold standard, those wonderful success stories of folks benefitting from the same drug for years and years.
(sigh) This is such a chess game, isn't it?

pjune127's picture
pjune127
Posts: 127
Joined: Dec 2011

Don't ever feel stupid. I don't know the answer to that question either and I need to know for sure! Certainly someone knowledgeable on these boards knows the answer. If not I will ask when I go back to Nashville on 11/8.

Max Power's picture
Max Power
Posts: 60
Joined: Sep 2012

the trial lasts 2 years for those who continue to have positive results. If, after the 2 years you stop and show progression, they will allow you one more year on it. After that, you are cut off, period. I guess the hope is that it is FDA approved by then.

Don't know the answer to your case.

Texas_wedge's picture
Texas_wedge
Posts: 2807
Joined: Nov 2011

Different in the UK, I don't doubt, and I'm not the knowledgeable person you need. (I feel certain an accurate answer could be had at once on ACOR.)

Meantime, it's interesting to know that there are folks around who've been on Avastin for 8 years. It was FDA-approved for use with interferon alpha in 2009 (approval rescinded for use in breast cancer treatment in Nov 2011 and there have been scares lately about counterfeit Avastin - the only legit source being from Genentech, part of the Roche Gp).

Presumably there are separate issues of its post trial accessibility prior to FDA approval (and cost issues, also, of course) and its continued viability as treatment, which must vary enormously between individuals?

When you're in Nashville, Paula, I hope you'll 'record' your results!

foxhd's picture
foxhd
Posts: 2213
Joined: Oct 2011

I've been told that my trial could last up to 4 years. I guess that is as long as I demonstrate a positive response. I hope I have nothing to respond long before that.

Hanno's picture
Hanno
Posts: 45
Joined: Aug 2012

As I understand it in Australia, unless a drug is FDA approved at the end of a trial, the patient can either participates in another study, or revert to receiving the standard level of treatment for their illness. This is regardless of whether or not the drug worked for them. A chess game indeed. Couldn't have said it better myself.

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