Pros & Cons of Studies??

[fretboard]

I talked to a nurse yesterday at UCD which is part of a training Hospital in my area, University of CA, Davis.  Anyway, I went there because my wife has a friend who is in one of their studies and recomended it to me.  I got on a list to get into a study prior to going to my doctor's Appt.  Can someone tell me the pros and cons of being on such a study?  Their sucess rate is 70 percent which is really what caught my attention.  My viral load is at 4 million, I am a Grade 1=minimally active, Stage 1 to focally 2, RNA quant. is 6.6.  I don't really know what all that means except I can wait for 6 months to see if a study happens and if it don't then I can just get the standard treatment from the Gastro doctor I went to see, we agreed on it.  thank you much.

[eagle1950]

I was in the clinical trial through Mayo Clinic in '95/6 to establish the interferon/ribavarin cocktail. High dose (5 million units) alpha interferon everyother day for a year. Ribavarin daily. It was kinda rough and many dropped out. But I swore to stick it out. And I was in the control group that got the real therapy. The other group was offerred that therapy free when they did not respond to placebo trial. It was a kinda tough year. I see people now with a series of 14 shots and can only think - how lucky. I musta done 175 of them for one every other day.........but I am and have been since 6 mo check up negative pcr for viral load. I am happy with that. The way they were talking I probably wouldnt be chatting right now if I hadnt gotten in the study - - do your homework - mine was in '96 - its been worth it - just keep the long term goal in sight......

[Trish77]

No problem.  Message whenever you like.

[fretboard]

Yeah, that's funny.  I was thinking it was something like that, it certainly makes more sense than where I took it.:)  Most likely when I find out more I would like to message you if that's ok cause I have other issues going on as well that I will have questions about.  later

[Trish77]

"naive" in this context means that you haven't had any treatment of any kind before, not that you are clueless. :)  And you're not clueless...have seen you from the time you hit this forum to now and you've picked up speed rather quickly.  I think you're doing very well.

[fretboard]

Yes and I'm a naive genotype 1A, I don't know why they put the word "naive" in there but they called that one right in my case.  I'm hoping to get into one of the studies and the results so far with Telaprevir are very encouraging.  My wife's friend can't say enough good things about the study that she's in, the people and doctors working at UCD etc.  I'm hoping to get into the one you referenced but I won't know for sure which one until they get their protocol and I fit the criteria.  thanks    

[Trish77]

Sounds like you are getting into the Phase III Telaprevir VX-950 for naive Genotype 1's.  Yes?  If so, I hope you get in this study. Good luck to you.

Trish

[fretboard]

Thank you and Jim for responding to my post, I will certainly look into the specific study drugs' side effects and post again when I find out more.  I feel more informed with your responses and I didn't even think of doing some reading on the side effects of the study drug because I was told that they are going into their III phase of the particular study that I just missed getting into.  Of course the protocol is not even in yet for the study I'll be offered so I will stay tuned and be asking more questions.  many thanks and God Bless

[jmjm530]

Some of the general "pros" and "cons" of being in a study have already been stated. The biggest "pro" in a general sense, is that you are able to try something not available to the  general public and the biggest "con" is that you may be in effect a guinea pig, because they may not know a lot about the effects of the drug they are trialing.

That said, what I think you're looking for are the pro's and con's of a *specific* trial. For that, you should collect as much information as possible about the trial, including what drug(s), what is the protocol, etc, etc. This hopefully  should be available from the trial coordinator in some written form. '

Once you get all that, you might want to post some of that info here -- along with your stats -- for more imput on that particular trial. But keep in mind that none of us are doctors here.

-- Jim

[Trish77]

In addition....

You need to look at the side effects of the trial drug.  On top of the regular side effects from SOC, you need to see what else you're in for.  

You need to read up on other studies on this trial drug and see what the risks are, particularly if it's in Phase I or Phase II.  Phase III trials are the least risky, have the most bugs worked out but are not risk free.  Just less risky.  For my trial, there was a noted risk of neutrophenia in the 78%ile...and I note they've dropped the top dosage to half as a result in the next phase of the trial.  So...ask questions and check it out before signing the agreement.

You will be limited in what "helper drugs" you can have.  Some people say you will get NO helper drugs.  Perhaps that depends on one's definition of those.  I can have Tylenol for headaches.  I can have sleeping pills from my family doctor.  Other than that.. not a whole lot.  So you will have to suffer through the sides more than others might with less relief.

[Trish77]

Pros:
The drugs and supplies are free
You are usually under the care of a research / teaching team.
You get more frequent and meticulous testing and they monitor you very closely.

You have a shot at a drug that is not available on the open market and that can increase your chances of a cure.  This is particularly poignant for Geno 1, as our cure rate is lower and to have it potentially shoot up to 80 - 85% with a trial drug is a chance not available to us on regular SOC without experimenting with the dosages and the treatment regimens IF you can get a doc who will go along with that.  It's also important for the other genotypes.. a cure is a cure, regardless of percentages.  I'm just saying...to have your odds shoot up like that is a big motivator.  At least..it was for me.  If it didn't have such good odds...I might have gone with regular SOC and played with my dosages.

If you don't clear, you are often offered the next round of SOC at no cost to you or something similar.

Cons:

You cannot tweak your treatment in any way whatsoever.  You have to stick with the trial regimen.  You have the option to drop out .. but .. well, I'd consider very carefully before getting into a trial in the first place as a trial is nothing to take lightly in my opinion.  They are doing research and they need results.  And WE need the results. To get results, they need people to participate.  So if someone is not truly committed to the protocol, they should leave it to those that are.  Now....that is my OWN opinion on that one.  Drop out if it's detrimental to your health as you go along.  That's the dealbreaker.

Sometimes you have to drive longer distances and much more frequently if the teaching hospital participating in the trial is a distance away from you.  In the beginning, that means frequent visits - for me it's once a week for four weeks, then every two weeks for four weeks, then four weeks after that and tapering off.  This is a Con for some people.

You don't get to choose or know what "arm" you are in.  This is not necessarily a pro or a con, simply a fact you should be aware of.  

I've heard some mention on here that you risk building up a resistance to the trial drug and if it doesn't work, then it won't do you much good the next time around.  This applies mostly to Phase I or Phase II trials where they're still tweaking the dosage and trying to determine what dosage works best.  Perhaps others who know better than me can weigh in on this one.

Food for thought....not saying I'm right...just offering my own perspective.  You'll sort out your own.

Good luck.

Trish

[fretboard]

Yes Dr. Rossaro, he oversees all the studies and he is the Chief of Hepatology.  I'm sure he's unfortunately come across this areas most sickest HepC persons.  I haven't met him yet, but I went there and had my intake paper work completed.  I hope someone chimes in here cause I'd definetly like to hear from someone who is going, or has gone through a study.  God Bless