Clinical Trials good or bad

It seems many are big on jumping to trials when tx fails.

Since most, if not all trials, involve study and control groups, is it really realistic to rely upon them as possible alternatives. Especially, since one could easily end up in the control group and be no better off than they were already on a tx which failed them?

I've also experienced where once tx fails you, the level of attention you receive seems to drops precipitously to the point that you almost have to beg to get the time of day from anyone in the medical profession.  Which has me wondering what one can expect if the participate in a trial and drop out or fail to achieve the desired results?

[friole]

I hear what you are saying. I am in the same boat with you but maybe have more options since my liver is in pretty good shape. Entering a trial is one option, but waiting for the new drugs to hit the market is another.

I don't think we can rely on a trial for a cure, but we sure can consider the option.   Do ALL trials have control groups?  I hate the thought of wasting a year of my life injecting sugar water.

As of yet, I have not found that the medical community is ignoring me.  What has happened to you to make you think this?  Even if your care is beyond the scope of the doctor you have been using, is there not someone else to confer with?  Have you emailed Dr. Cecil?

Oak, I think you are pretty depressed right now and I am sorry.  But you were getting nowhere with the current protocol and you really did give it your all.  No one could ask for any more of you.  Surely you have helped your liver with the treatment you have done.  I hope your anemia resolves soon and you can get into researching the options.  
kathy

[NYgirl]

I thought all studies had one arm placebo one not type structure so that they could compare one to the other?

I always figured it just wasn't worth it and I KNOW my luck.

[Alady1620]

The study I was in did not have a placebo.  There were 4 arms of the study with different dosages of NM283.

[mremeet]

Not all trials have control/placebo groups. Especially later phase (i.e. phase 2b -> 3) trials are often unblinded and without control groups. The best bet if you're looking for a cure is to avoid short term early phase 1-2 trials and stick to more advanced longer term trials. For instance, I'm pretty sure the upcoming VX950 trial for SOC non-responders does not have a control group (might wanna check on that though). Plus it is of sufficient duration (in length) to have a good chance of curing you...if in fact the VX proves to be as effective as we all suspect, AND it doesn't have an overly harsh side effect profile (as it turned out to for myself and PDS).

Best of luck...

[orleans]

Hey, Is'nt NM283 the same as valopicitabine. I'm looking at the trial with peg/riba. How did that go for you. jm

[APKhaos]

Its not just when TX fails. New drugs are coming, and they are being tested in trials. As mremeet says, trials in the later phases may not have control groups. Even so, the number of control group subjects is usually a small proportion of the entire subject cohort.

When I looked at this, it was a case of choosing SOC with less than an even chance to clear [Geno 1, VL of 27million] or joining a trial which had the potential for a higher chance of achieving SVR. There are no guarantees, but the trial seemed a good choice at the time. I've read a lot more now than I had then [largely due to the terrific knowledge & experience right here], and I'd choose the trial again without hesitation.

The fact that drugs, labs, and clinical visits are free of charge can be a godsend for some, as well.

Given the large numbers infected and still being infected, we need more effective [and less debilitating[ treatment that today's SOC. We only get there if people are willing to take the risk of participating in trials.

I agree that they are not for everybody.  

[APKhaos]

The VX 90 Prove 3 trial is specifically for geno 1 non-responders.

The earlier Prove trial were for treatment naive subjects, but that's changing. The Prove 3 trial is signing up subjects pretty soon, so now is a good time to put yourself on the 'interested' list. Look for a site that is participating in the Prove 1 trial. They are most likely to be running a group in the Prove 3 trial too.

Somebody here has a list of the Prove 1 trial sites too.

[HCA]

I have observed that phase 2 seems to be restricted to naives and phase 3 plan to admit relapsers/non-responders to a branch of the trials.I agree that trials are weighted to give the best results for corporate reasons.I guess we cannot object to that,for the sooner FDA approval is granted the sooner the rest of us poor suckers can get on board.

[chcnme]

Hi Grand Oak. Sorry you've felt this way (or been treated this way).  The reason I am considering trials is because I'm treatment naive (with the exception of two weeks prior in 2003 with peg/rib) and because I was intereted in the VX and bumping my chances up at first attempt, and because I feel that being under the care of the docs at this research clinic gives me the best care I can receive -- whether I wait and do nothing now,  or whether I get in a trial, or whether I decide to treat now with standard combo.  In my case (since the only trial I will consider at this time will be with the newer drugs given in combo with the Peg/Rib) I really don't mind if I wind up getting a placebo as long as I can get an SVR. I kind of look at it like -- SVR is SVR no matter what, and SVR can be had with SOC.  The fact that a trial also gets me the drugs at no cost is great,too.  The fact I can pull out at anytime I want is good, too.  

As far as having concerns about getting the "real deal", my main concern is safety and drug resistance.  

About the Vertex -- they have been very strict on their criteria according to my doc and research coordinator (and according to what I've read here and at other sites.)  HCV 796, on the other hand, that will be launching a Phase II sometime after 2007, possibly March/April  (not sure yet - just know it's coming and is for tx naive and nonresponders) is not as strict with their treatment naive studies, apparently. My doc has told  me that even though I've had two prior weeks of treatment, I can still get in this trial (whereas with the VX-950 a waiver of those two weeks was not possible.)   I will get SOC with this one, too.  He's also told me that this could position me better on down the road with future trials with them, and that if I don't respond or have to be pulled,  the treatment does not stop.  He has been very reassuring that they will remain very much involved in my treatment  (or he will, and that my options will in no way "run out"  if the HCV 796 doesn't work for me) .  If anything,  he has indicated it will possibly give me better options  (as far as trials.)  

Doc also told me today there may be future concerns with the VX-950. He didn't say this to me as if he knew of any bad news on the horizon or anything like that.  It came up because I mentioned to him that I had met some people on-line who were in the tx naive trial and that one had been notified recently to stop the VX  (and that's when the doc said we could see some problems with this drug in the future.)  He didn't say this as if he had inside knowledge of any known problems right now or to sound discouraging (don't want anyone thinking that.)  He just said it as a matter of fact, as any good doc would comment about these newer drugs and the risk some won't make it.  We were also talking about drug resistance at the time.  

[avidreader]

I think one of the biggest reason people who relapse or are non-responders pursue trials is because their insurance companies won't authorize a second round of treatment or treatment extension. I know that when I was treating my doc was already looking for trials for me in the event that I relapsed because he knew my insurance company wouldn't authorize a second round of treatment.

[crsrph]

i just got taken off the vx950 trial 2 days short of 12 week compleation would still do it again if given the chance . aside of some blood dyscrasias low platelet low hg had no physical sx and actually feel beter than when i started tx . i was at trial location today they treated me very nice and sent me home with 4 months of copegus pegasys so i can not complain about the treatment i have received which I think has been 1st rate .

[nick m]

Hi all
first time on. I' m on the vx950 stage 2 trial. last screening appt wednesday then treatment starts 4th  jan 2007.wish me luck. I got a lot of ID off this site - laughed when i saw the familiar phrase -'knowing my luck' re the vertex lottery. 75% for the vx950 then 50% chance of clearance with combination therapy if i get the control arm. I've only been eligible for funding for treatment since august and am in good health - but finally persuaded this thing doesnt stay still - like rust - so now or never. I'm writing it up on my blog which is 'nickaround'. seasons greetings to all. love and fellowship nick m xxx
AKA honest leopard
"I create a world of safety through courage honesty and humour"