study results

Hi everyone. i am new here. i have an issue with my tx study nurse. i am on the naive 1a roche r7128. it seems that he is not being straight with the viral load results. he has been off a couple of thousand every time i am checked. i ask him what the level is and i guess he don't remember what he told me the time before and ups the amount. the time before last he says its at 7000. this time he told me is was at 1000 down from 8000. hes done this a few times. i know its not much but at 4 weeks it all matters. i think i am neg and he wants me to believe the virus is still there to keep me on the meds and study. has anyone had this problem? livinlarge

[epiphiny]

Can you request a hard copy of the PCR results?  I was on the Phase 1 R7128 trial and after the intial 8 weeks I was able to get copies of my results in the form of a chart from the lab via my study coordinator.  Mine was a double blind trial and so they didn't give out any information until the 8 week period when I was on study drug or placebo was up as they didn't want to influence my behaviour or attitude toward the trial or drugs.  I can understand that.   I also know they weren't entirely honest with me as I would ask if the results were back and they wuld say no, however when I got the hard copy back the dates the info was faxed through to the centre were in fact within the dates I had been asking for info.  Perhps that was related to the double blind status of the trial.

The other way round it is to get your private PCR/VL test done.  Quite a few folks on this site have done so.

All the best,

Epi :)

[Tippyclubb]

My trial never told me what the vl was until the 24th week.  I needed to know, so I had my doctor write a prescription for a PCR and went to Quest labs and had blood work done.  

The first one I did not have insurance and it cost $450, the second one I did have insurance and Blue Cross covered it.

[livinlarge]

thanks for your comment. it is a double blind but they have access to the test results. the first test he let me see, baseline. however, now he does not let me see any paperwork. i have to ask for results and he seems irritated that i ask. i do believe its neg right now. i guess they feel like they gotta play the game to keep us in. thanks again

[copyman]

you have every right to those results. if they get hard copies then you are entitled to them. the study i was in was blinded only to the pcr, the safety bloodwork CBC, CMP, etc were available to me. as for the PCR i did what tippy did and mine done privately.

[livinlarge]

did your results differ from what you were told? i am thinking of getting pcr ran, my insurance pays for most of it. he said all bloodwork was fine or i would have heard from him. it kinda irritated me. appreciate your input.  

[copyman]

i don't think anything is wrong with the doctor saying "bloodwork is fine otherwise he would have called" but you are still entitiled to the copies! Sometimes the doctor feels the patients don't know how to read the results so why give them copies. Tell him you want them anyway for your records. The other thing is they don't want you to worry so you don't drop out of the study.

[newleaf09]

If the study allows you to be informed, get a copy.  The research site gets enough funding from the sponsor to afford copies for you.  If informing the patient is not permitted (the recent teleprevir trial was that way), get a freindly doctor to prescribe the PCR test for you, as Tippy suggested.  I made a big table of all of my results and have looked back at it a thousand times.

Sometimes it can take quite a while to get the study personnel to see you as an intelligent participant. An awful lot of them think patients either don't care or are too stupid to inquire.  Keep trying to get through to them.  You will be happier and feel a little more in control in the loop.

[livinlarge]

i go back in 9 days.  i will request copies. thanks for all your inputs and i will report again next wednesday.     livinlarge

[Trish77]

I got a copy of my chart every time I saw my study nurse - she told me I was entitled to my results and so I was and so are you.  Just tell him you want a copy of all the results as you go. Sounds like he won't be too thrilled but too bad.  I would also go get a PCR just to be able to have an independent result considering the trust factor is questionable here.  Good luck.

[livinlarge]

talked with study nurse and he says i have no rights to the tests results untill 24 weeks. he says it could influence my attittude about the study.  i had a pcr done on my own this morning.  this is week 7 i figure i was neg at 4 weeks if not before.  i am willing to do 24 weeks of study 100% but i'm not sure about 48.  livinlarge

[Trish77]

Some studies don't release the results. Maybe someone else on the R7128 trial can tell if they release the results?

If this is that doctor's decision, then continue to get PCR's on your own.  Does he at least give you the results of your CBC's?  Tell you what your hemoglobin and ANC levels are?  Give you ANY test results?  If not - well, depending on your circumstances, I'd consider getting off that study and getting on regular treatment or do your homework, find out if others get results on this trial and fight harder for yours.

You could go to the Roche website and call to ask what results patients can have on this trial.  Email them even so that you can print it out and show it to him.  

Just tossing thoughts out here.

[copyman]

That may very well be that studies protocol so just get the copies at 24 weeks. You  are smart to do your own PCR's. I would get another one at 12, 16, & 24. These PCR's will help you make decisions, like stopping at 24 weeks, etc. Keep in mind studies have shown that to shorten TX from 48 to 24 weeks you have to be undetectable at 4 weeks. Don't shorten tx unless you are 100% sure. You cannot "think" you were neg, you have to have proof. Why jepordize the whole tx when you don't really know for sure. This is why it is so important to get a PCR at 4 weeks even if the patient has to get it and even pay for it privately.

[newleaf09]

The opportunity to be randomized out after 24 wks is totally dependent on clearing within their guidelines for early response.  The info should be in your copy of the informed consent.  That is "response guided therapy", a direction researchers are currently pursuing.  I personally would be nervous about making the decision to stop on my own without having the PCR's to back it up.

[Isobella]

Sorry to jump in late to the conversation like a lead brick, but being in a double-blinded study myself, I have to say that double blinding means just that.  From the patients standpoint, they signed on to do the trial knowing they would not get the results until a certain point.  

In my trial, I was given my baseline...meaning the VL from the day I started the trial and wasn't given anymore info on VL until week 48.  But I knew that was going to be the case from the protocol I signed when I started.

Please review the guidelines and your informed consent for your study.  It may very well give you clues as to your status.  Even double-blinded, you will know how you are responding based on whether or not they continue your tx.  

Whether or not you get PCRs outside the study or not, I can't advise you.   I do believe we all are ultimately responsible for making our own medical decisions based on the best data we can get.  But I also think we should try to maintain the boundries set up by the studies we have chosen.  

Best not to make any decisions without absolute confirmation.

I wish you the best with your trial.  My doc seemed to be very excited about this one in particular.  Hope it all works out well for you.

Isobella

[Willy50]

"Please review the guidelines and your informed consent for your study.  It may very well give you clues as to your status.  Even double-blinded, you will know how you are responding based on whether or not they continue your tx.   "
_____

I think I agree with the first sentence.  Your trial guidelines and rights should be spelled out in your agreement.  Read it and understand that's the way it is....

The second sentence is iffy. In some trials and circumstances you'll know; in others, maybe not.

First of all every pharm runs their trials differently.  The trials are similar but each one is a bit different from Roche to Sherring to Vertex.  They all had different parameters on rescue drugs and they have all had slightly different styles on blinding and disclosure of results.
If I remember correctly in a phase 3 Vertex trial they were leaving it blinded for quite some time.  One party was taken off at 24 weeks but not told whether they had not achieved UND or had broken through.  They had only been told they could no longer TX based on the trial design.  They thought they had failed.  I mentioned to them the possibility that they had cleared w/in 4 weeks and maintained the UND through week 12 and 24 and that they were in a 24 week arm.  The odds were that they had succeeded but that they could not be told that since in effect it would be unblinding the results early.  Vertex wouldn't tell people if they had succeeded either; that was to remain blinded.  It was all in the trial agreement.  You have to be careful what you interpret.  You have to be careful NOT to assume.  Read the agreement.  That's where the answer lies, I think.

Get a private PCR so you'll know at appropriate times.  (and I also assume that your agreement forbids you disclosing the results on pubic forums if it is still blinded)

best,
Willy

[Isobella]

Change "will" for "may"

I usuallydon't post absolutes...that one slipped by.