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Are dropout rates in trials higher than SOC?
by Andiamo1, Apr 06, 2008 01:04PM
Many people refer to the high dropouts from the Vertex trials. Having just completed the prove 3 trial, I have come to believe that trials are not for the faint of heart. There was a 25% chance of getting a placebo in Prove 3 and we are flying blind, since we can't see viral loads for 24 weeks!
My personal feeling is that if I knew that I was responding well and not on a placebo AND I had rescue drugs, I would be less likely to drop out.
Just curious about what other people think about the impact this would have on the end result.
Eric
My personal feeling is that if I knew that I was responding well and not on a placebo AND I had rescue drugs, I would be less likely to drop out.
Just curious about what other people think about the impact this would have on the end result.
Eric
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People have to be blinded. That is how the world has proven that even "nothing" (sugar pill) can treat an illness if one or more people believe it can cure or help (placebo effect is REAL!).
We take part in the trial because our life is shot and we want an early chance to get better, or a chance to speed up a cure. We know when we go in that it is an experiment and some things have to be standardized if the results are to mean anything.
Yes the trials can be very unfair and can even ruin your life, they can also change it for the better. Everyone takes their chance, it's a **** shoot.
cheese
doing vx/riba/peg and loving it so far!
Doesn't anyone play dice?
But more than you know - this treatment --- any treatment stinks... and it stinks for a long time. So SOC or TX via Trial are both NOT for the faint of heart.
I think there is more hope on the Trials --- because you get more of a chance to test something --- that "MAYBE" "MIGHT" "COULD" possibly be that "MIRACLE" cure.
I also think that you are watched more closely on Trials -- you have other people that depend on you. So I think the chances could be lower of dropping out on normal TX than on a trial...
However, that being said - I really don't know how many people drop the TX on their own and never mention it. I know that on SOC TX - it's hard... and harder for some than others. I also know that you don't get a lot of follow up with your regular doctors, unless you have a really aggressive and hospitable group of doctors who really care about their patients... It's more like: "here ya go --- take this... see you in a few months - too bad about the side effects --- never heard of anyone else having these problems, as a matter of fact... this 70 year old just came in and told me he was doing fine after a year of TX and he's off to Aruba... Oh, here's my next patient. Call if you think you're having any more problems, but I don't expect any..."
They don't know. These doctors. Any of them. If they haven't had the TX --- whether SOC or Trial. They have no clue what is happening both mentally and physically to the patient.
But----on the Trials --- they are looking for anything out of the ordinary. They are searching for problems... They are trying to solve the problem. They take into consideration more of the issues than a regular SOC doc might...
At least... That's kind of my take on it. LOL!
I just wanted to post that I've thought of you often and of your determination and bravery. And I missed you!
Super Hugs,
Meki
Great to have you back!!
Eric
Eric
Eric
I agree with your points as well. I got so excited when I saw your post that I forgot the question I had asked!!! LOL
Eric "
LMAO --- love you too!
Doing ok - had a very long 4 to 5 months. Got deathly illl - probably from just coming off of TX and having no antibodies... Plus the girlie things going wrong... Had the surgeries - feel incredibly better... but they cracked my pubic bone (which believe it or not can be painful... LOL!) and the mesh implant they put in tried to come out through my skin - which was a bit uncomfy... LOL! (to say the least)... Got the implant fixed 2 weeks ago... Still trying to not hurt every time I sit or walk or climb stairs (live in a 3 story home... LMAO!)... But life is getting MUCH better...
And my brain is almost functioning.
Amazing --- how much a difference a year can make... You know?
Didn't know for sure if I would even be able to start functioning again at the type of work that I do... But it's all starting to make sense again.
Much HUGS to you... How are YOU doing?
As non-responders, I do not think anyone should underestimate the "motivation" of the non-responder group of patients. If I am typical at all.......I feel like an arrow, ready to be launched at Telaprevir and boy, I'm getting strung pretty tight! I am overflowing with motivation, abounding in determination and ready to go. So, yes, I think there will be some impact on the general public and the numbers relating to SVR when Telaprevir is approved. The numbers will be impacted both positively and in a negative way......a big giant world/trial for SVR. Just give me the chance.
Willow
Willows: I think you are correct. There are positives and negatives and they probably balance in the end.
I have been very difficult to get along with since I stopped. I have been fighting with everyone for two weeks. I am starting to feel much better now and things are settling down a bit. Mafalda is smiling again, so I must be better - LOL.
Jim has a theory that I must be SVR and that my immune system was so revved up by fighting the virus for 40+ years, that now it is just going crazy. I like that theory!
Sounds like you had a tough time, but you are starting to feel better. I am so glad to hear that everything is starting to look up now.
Eric
Oooooooooooooooooooooh Baby! I'll bet she is!!!!! Hopefully in more ways than one!
"""Jim has a theory that I must be SVR and that my immune system was so revved up by fighting the virus for 40+ years, that now it is just going crazy. I like that theory! """
Jim has some pretty interesting theories... LOL! that is just fantastic... I know that when I first came off of the TX --- I was grumpy... Grumpy was not in my vocabulary prior to TX.
The stuff messes with your hormones --- and hence your emotions. Maybe you turned into a woman! (ROFLMAO --- just kidding --- but it was a funny thought... for a moment!)
I'll bet after so many years on it - your poor body doesn't know which way is up. Breathe sweetie. Cause now it's just patience... and well --- sometimes it's just about the breathing too.
You've fought harder than most - and no matter the outcome - you've stood up to the challenge and faced it head on.
She should be proud of you - and you should be proud of yourself.
Rescue drugs might be discovered against rash, nausea (gravol works wonders), anemia and mental meltdown. That would reduce droput and possibly increase svr.
Then is the possibility that the person in the trial might stand a better chance for response due to character (positive outlook, risk taker, willing to suffer for less than positive outcome...)
Who knows.
Susan
especially for retreaters...it'd be like...tell me this is going somewhere of forget it...
of course if they did...then the placebo factor is nullified but for my money especially with no recue drugs, and anemia risk higher for retreaters...they owe us that.
Besides, there's also the old are we creating an more resistant strain argument.
I still don't get how you treated so many times. You either have the constitution of a horse, or something!!
as to your personal feeling....one might argue knowing you weren't responding could also increase the drop out rate.
So how was the rash for you? Did you have Riba skin stuff and was it worse or better on the Vertex/teleprevir?????
The underlying question in my mind is: would the SVR rates improve if fewer people dropped out? The question you raise is interesting because if people dropped out because the didn't respond, there would be no impact on the SVR rate. But, if people stayed in because the were responding, there would be an increase.
I hope you are well. I see that you are now undetectable - I am happy for you.
Eric
Eric
Thanks Eric.
Trish
By the way, the more I read about the trial you are in, the more it looks very promising. Perhaps the next trial will include both drugs.
Eric
I am thinking that the picking of the participants would not affect the outcome. If it did, then the study would be of much less value.
In a trial situation, they handpick the cohort of people they will use in the trial and the parameters for acceptance (sex, age, disease characteristics, previous treatments, etc.) depending on what they are trying to prove or disprove. They will assign the patients at random from the cohort to different treatment arms (different TX vs. placebo or SOC). This is done at random so that, if the sample size is large enough, they can compare the rates of SVR, etc. between the treatment arms. There would be no "handpicking of which patients go to different arms of the study. Any biases in the picking of the cohort would apply to all TX arms of the study.
I felt lucky to get in the study to begin with however if I thought in my heart that I wasn't getting the 'real thing' then I don't think I could have made it. There are several queues to know what is going on and some are even encouraged to go to independent sources to verify the efficacy of the drugs they are taking.
So I think it's about the same drop out rate to the degree that one doesn't know if they are truly being treated or not. I KNEW I was being treated by the symtoms and 'other methods' to know so that gave me great motivation to continue. As well as you and others that were open with their struggles and hung in there.
Warmly (4 weeks to go)
Scotty
A study with only one arm is hard to draw tight conclusions from. That is why the double blind ones with multiple arms are of the greatest scientific benefit. If the entire cohort is on one TX arm, then there is no comparison unless other studies and TXs had the same qualifications on their cohort.
Also, there is what Scotty says: "I KNEW I was being treated by the symtoms and 'other methods' "
It is hard to quantify what the result of motivation and attitude are on disease. I am a believer that it helps whether there is scientific evidence to back it up or not. I am a little soft, here.
I am not sure the study design can eliminate all forms of bias. Maybe the best we can do is identify the potential sources of bias, like you have pointed out.
Brent
I am glad I made sense to you, but I am not sure how that reflects on your judgement ;)
Igottagonow! Sleep bekons.
Best to you,
Brent
In some ways, in a double blind trial and with these drugs, it's hard to "hand pick" I think....but the screening process itself does eliminate certain things by necessity. Those who've ever had a history of various health situations aren't getting in. That makes sense to me too. There are no rescue drugs, so you don't want extra health complications thrown in to deal with when you don't have the tools to apply to them. Also, the data is more pure. You're getting "baseline" results, so to speak. Beyond that, when the arms are multi and double-blinded, it's all left to the pick of the draw.
Trish
When this trial started they said no rescue drugs allowed, but when my blood counts crashed a couple of weeks ago they desided to allow me Procrit and Nuepogen. So in this trial Roche is allowing rescue drugs.
Thank God because I would have had no choice but to drop out.
So there is a heck of a lot of "cherry-picking" going on, but considering the cost of the trials and the difficulty of getting a drug approved...Vertex can cherry pick all they want! The ultimate goal is to get the drug approved and available to all of us.
How could anyone insure a fair, representative sample of patients anyway? There is a whole world of unique folks out here? What's important is the approval of the drug.
Willow
Percentage of drop-out rate in regular SOC is around 5 - 9%. Now.. I need to research that a bit MORE to conclusively settle on that number. That is one of the figures quoted in a comparison between regular SOC dropout rates and the trial in question, which was SOC for those with end stage renal disease and HCV.
In general however .. reasons for drop-out rates in clinical trials included:
* Location - the further away from the trial centre, the greater the chance of drop-out due to non-compliance
*Depression - considered a major reason for drop-out in both clinical trials and SOC - I know my trial was very stringent on depression and now I begin to see why. I imagine they all are, yes?
*Intolerable side effects
Telaprevir trial drop-out rates in a couple of the articles were noted as 9% in Phase I and 12.5% in Phase II apparently. I don't know about Phase III/ Prove 3? I do get confused as to the difference between Prove 3 and Phase III - could you enlighten me please?
So .. with such scant data as I've provided, it seems that clinical trials have a few extra reasons for drop-out. Distance, more sensitivity to depression, intolerable side effects when you take into account that there are no rescue drugs or a great reluctance to use rescue drugs until absolutely necessary.
With that in mind, the drop-out rates for Telaprevir don't seem that out of line.. IF my numbers are right.
And Laurie was right .. our R1626 trial does allow rescue drugs but they'd rather do just about anything else first. So it's not NO rescue drugs in our trial but certainly they won't be coming easy and unless absolutely necessary. Dosage reductions will come first.
I know this comes very late ... but it's been simmering on my "really want to do" list and it finally came up. Hope it's not totally redundant by now. :)
Take care.
Trish
My own experience with the Vertex trial is that it was very demanding. I had to keep a diary and had many visits to the medical center. The most difficult part of the trial for me was the lack of PCR results. If I had known that I became undetectable by week 2, it would have been much easier to take.
I do think that Prove 3 will have fewer dropouts than the rest of the trial, because the trial was made up of people that failed prior treatments. I think those of us in Prove 3 worked hard to get into the trial and were very motivated to stick with it.
I think that after some experience using the new drugs, the docs will be better able to treat the side effects and coach the patients how to better deal with them.
Thanks for doing some research. I think this is an important topic.
Take care,
Eric
I also remember somewhere getting the information that the trial Eric was in observed that non responders did not fair well with tele. Maybe arm C was sort of their control for this.
I agree with you .. that the PCR's are important. We are getting them all the way through. We're still considered double blind, in that neither us nor the researchers will know what arm we're in til we're done the protocol .. however, we do get our results each time we go, the CBC and the PCR. Our Australian friend in the same trial, Emi, wasn't going to get his until 24 weeks and when he found out we will get ours at each visit, advocated for himself and now he will get his every other week at least. Interesting.
Do you think PCR's can also work the other way? That people would drop out if they knew the results were not favourable? I knew what I was getting into and I already knew I would not .. but then I have some time on my side and I felt I could afford to make that kind of commitment.
Gluck: that is the only reason I would drop out .. if the side effects were too threatening for one reason or another.
Wonder if rescue drugs introduced as a last resort as in my trial would make a difference? Laurie had them and is still in the trial.
Interesting discussion, Eric. I too think it's important. Partly to understand the results better and to understand the risks to ourselves better.
Regards,
Trish
I've heard about the rash but not this. Do you have more information on this?
Trish
Like Trish, I never heard of any organ failures and that is not included in the Vertex paperwork to the best of my knowledge.
Trish: You make a good point about the dropouts caused by people being aware of not responding.
I think if you look at the impact of dropouts on SVR the results will be different if the PCR tests are revealed, but perhaps not when you just look at total dropouts: more people that are likely to relapse will dropout and less people that are likely to succeed will dropout. What do you think?
Eric
I think that if I hadn't seen at least a sizable drop in my viral load in the beginning I may have dropped out by now.I'm 10 weeks in.
As it is I went undectable at week 2...so it causes me to stay in.
The trial is an aweful lot of drugs. Side effects are very ruff. Roche is allowing rescue drugs for me....but even those come with their own little sides.
If the trial wasn't working I don't think I'd be putting myself through all of this. I'd probably dropout and seek out reg. tx.
One thought though.....
"more people that are likely to relapse will dropout and less people that are likely to succeed will dropout. "
Are they relapsing because tx didn't work for them or because they dropped out before completeing tx?
Laurie
_______________________________________________________________________
I meant that in blinded trials, dropouts would be random, so people with a great chance of SVR would be included in the dropout rate. In unblinded trials, people with EVR would be less likely to dropout and people with poor viral response would be more likely to dropout. This would be a positive influence on total SVR rates.
Eric
We DO get our results as we go along, both viral load and CBC. Is it possible that getting your results along the way has nothing to do with being blinded? I can't imagine being in a trial that tells you NOTHING about how you're doing until you're done. That seems reckless. Can you explain further please? Thanks Eric.
Trish
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See now this brings up an interesting point. A trial is different things to different people.
I wondered how much response plays in a trial. I wondered how many people would drop out if they weren't doing well .. or as well as they wanted ... as they'd be less committed to finishing a trial than treatment, particularly when you don't know your dosage and you think you might do better with regular treatment.
Also, in Laurie's case, if you feel the trial drug is impacting you negatively and you're not responding as well as you'd like...there may be not much incentive to hang in there.
If you're later stages ... then perhaps even less because you don't want to use up one of your "nine lives" for what is now appearing to be a waste of a remainder of 30+ weeks when you could be taking more targeted treatment.
One of the reasons for me going into my trial was that I was Stage 1 damage. A throw of the dice means I might just get the trial drug .. and while I don't want to have to go through this more than once .. felt I could tolerate that if I had to for the chance at a kicka$$ drug that might knock this out of the park much better than SOC would.
So .. have been meaning to post that speculation on my part and Laurie's comment was a good segue into that.
Trish
Trish
Viral loads with Telaprevir respond very differently than SOC, so a trial with previous non - responders would allow people to figure out what arm they were in, since they would see a radical difference if Telaprevir was in the mix. I think that might not be true for naive patients with no frame of reference.
Eric