Boceprevir Question

Just trying to understand all this unblinded and plebcebo stuff...if the study nurse and me dont know if im taking the the real drugs...who does know and how do "they" know...does it go by a number system?....someone has to know whos taking what?

[kickboxingmom]

I don't know about HCV and the study but my husband was in a study for Humira and Crohn's .I ask him the same question and his reply.You just know.Your body tells you somehow.I don't know if this will help but it can't hurt.
Tammy

[Bill1028]

From what I understand each person is assigned an identification number.  The drug company decides which arm we are in and supply us (by the identification number) with the corresponding drugs.  We will not find out which arm we are in until all of the results are in.  Waiting is the hardest part.

In response to your other question in the other thread.  If you are in Arm 1 and receiving the placebo and do not clear at week 12, you have the option to stop or continue and be given the real drug.  Hopefully we are all undetectable before week 12.

[Rockerforlife]

YOU SAID:Hopefully we are all undetectable before week 12...

Not really...if you are in arm 1 doing the SOC drugs along with the fake drugs...you will continue 48 weeks with just the SOC drugs..i guess it all depends on what arm you are in...put it this way...if i am in arm 1...i want to be detectable at week 12 so i can get the real thing....am i making any sense here?

[epiphiny]

If it is UNblinded then, yes, the sponsors will know whether you are on placebo or not.  If it is blinded then absolutely nobody knows who is on what and this is so that the results cannot be influenced in anyway.

As to how the placebo or study drugs are divvied up they use a randomization protocol which is as Bill has already described.  You are assigned a number and then that number is randomly assigned a protocol which is decided in random fashion.  For example the way they play the lotto balls in a lottery.

If you google randomization you should come up with some good info about how it is done.

Epi

[Rockerforlife]

looks like arm 1 is a bad arm to be if you clear at wk 12....better to be detectable at week 12 in this arm ...this way you get into the PROVIDE  trial...thet will also give you the real thing ...sounds strange to me

[Rockerforlife]

epiphiny....but someone has to know...or how do they determine who continues and who dont?....the drug company has to know?

[FlGuy]

And more, a blind study means the patient doesn't know the drugs. Double-blind means neither the med folks nor patient knows. Yeah, like anything else you're just a number.,

[epiphiny]

Not sure how you are going to control whether you are detectable or undetectable!!  It's pretty nerve wracking,isn't it?

[Bill1028]

Yeah, I understand what you are saying.  My point is that the interferon and riba are not working, and under ideal circumstances all 3 drugs are working.

[Bill1028]

sorry, posted in the wrong thread

[epiphiny]

Oh yeah, I forgot that, double-blinded.  

My study was double blinded.  In my trial your response was what governed who continued on.  But mine was slightly different in that everyone got SOC afterwards EXCEPT if you didn't respond to tx.  And if, when it was unblinded, you were on a placebo then you went onto another trial in 6 months time that assured you got study drug.

I still don't know whether I was actually on study drug or not, but by my results it appears that I was.

Also, I knew that I was on study drug, as Kickboxingmom has mentioned, as I could 'feel' it in my body.

Epi.

[Rockerforlife]

If they say there is an 80% chance i get the the real thing....i wonder if this refers to each indivdual study group or the 80% to the whole study?....what im getting at is if there is 10 people in my group.will there be a chance we all get the real thing...how are the drugs radomized  on the whole or in specfc groups?  sorry if im not making sense

[whiteonyx]

I agree, I hope I'm detected on week 12, I want to see if and I pray this new drug is the answer, because last time didn't hold and my levels are up one since...

[epiphiny]

You are making perfect sense to me as I had all the same thoughts and questions when I was starting out on my trial.

As far as I understand it, the % relates to each group, or arm, or cohort, or whatever language your particular trial is using.  So, it means that 80% of arm 1 will get study drug or 4 out 5.  In other words, 1 person out of every 5 in your arm or cohort will be on placebo.

[can-do-man]

From what i was told that sense this study is "double blinded" that it is done by a computerized system, maybe all in your group could get the real thing or nobody gets the boceprevir. which would be unlikely.

If i do get in this trial being that i was not und at week 12 in SOC then i will have a good ideal this time. So if i'm not und i will just go into the "provide" study knowing for the rest of tx. i will be getting all three drugs.

cando

[kitkat14]

I think the study works like this...

The study doctor (and you) do not know what arm you are in, but the company running the big test does.  This way the study doctor does not inadvertantly skew the results in either direction, for or against the new drug.  The results are presented to the testing company in statistical data (number) form, and then the results are sorted by the corresponding arm of the trial to come up with the various percentages.
If you do not reach UND by 12 weeks, and you are in arm 1( placebo group), you are given the option of continuing with the new drug or discontinuing altogether as a non-responder.  As to whether it isn't best to NOT be UND by 12 weeks if you are in arm 1, I think it really depends upon whether you were previously a relapser or a non-responder.  If you were a relapser, you would want to make sure that you got the new drugs during this treatment time even if you had to start all over because SOC hadn't adequately worked the last time.  If you were a non-responder the last time around, and this time you were UND despite being in arm 1, I'd say go with the flow and just keep doing what you have been doing maybe it will work this time.
Because the test is randomized, you could have all participants in a study group receive the real thing the first time round, or far less likely you could all receive the placebo the first time around.  It's all in the odds in the end.  That said, I think it looks promising for anyone particpating in this trial because they give you the guarantee that one way or another you will get to try their new drug.
k
  

[Rockerforlife]

Well said...but to to me a non-responder and relapaer are pretty close to being the same thing...now a nul responder is a whole different animal all together...i cleared sometime between wk 12 an 24 so i consider me a slow responder..either way...if im still detectable im going for the" PROVIDE" part of the trial...i want the BOC bad...thank you for you little article...LOL...it does help.

[Rockerforlife]

The worst thing that could happen here is if i clear before wk 12 and im in the control group...this means i would have no choice but to continue on with the fake drugs...BUT the ods are i will not clear by week 12 if im in the control arm because in my last tx i dint clear at weel 12....so this looks ok then....yahoooooooo

[Rockerforlife]

sorry bout the spelling....

[kitkat14]

You're right, when I said non-responder, I was really talking about a nul responder (as in no change in viral load at all).  If you're a slow responder, you probably wouldn't clear by week 12 anyway so you would be offered the real drugs at the 12 week mark.