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Author Topic: Question about Placaebos  (Read 2333 times)

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Offline Esquare

  • Member
  • Posts: 237
Question about Placaebos
« on: October 05, 2007, 12:42:09 AM »
After reading several bits of study data a thought came in my head that I don't know the answer to. When you are a part of a study do you ever find out if you were given a placaebo or not? If you quit the study before it ends do you find out and do you find out if you had the placaebo if complete the study?

Offline anniebc

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  • Posts: 5,914
  • AM member since 2003
Re: Question about Placaebos
« Reply #1 on: October 05, 2007, 01:00:42 AM »
Quote..."Appropriate use of a placebo in a clinical trial often requires or at least benefits from a double-blind study design, which means that neither the experimenters nor the subjects know which subjects are in the "test group" and which are in the "control group"...Unquote

Not sure if this little piece of information helps...but I would take a guess that the answer to your question would be no...but don't quote me on that.

Take care
Jan


-----------------------------------------------------------------------
Never knock on deaths door..ring the bell and run..he really hates that.

Online emeraldize

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  • Posts: 3,327
Re: Question about Placaebos
« Reply #2 on: October 05, 2007, 01:19:25 AM »
Hi Esquare

While the study is in progress, the participants and researchers do not know as Jan quoted. However, if you're in a study you DO get to find out after it's complete. I don't know if they let you know if you bail out early, I doubt it unless there could be a complication if you are not on placebo and instead on a drug which may have a lingering life in the body.

I learned this because of participating in a study at the NIH. The study tested the potential for Alethia, a drug used for arthritis patients, to have an effect on HIV patients CD4 cells.

At the end of the study, they informed me I was on the drug. Then, I had to take another substance regimen to remove the drug from my system.

If you're asking because you're considering participating in a study, I encourage you to try. It's quite a process to join a study and they don't allow you to sign lightly.

Offline whizzer

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  • Posts: 363
Re: Question about Placaebos
« Reply #3 on: October 05, 2007, 12:46:26 PM »
Some studies "unblind" the drugs and give everyone the study drug at some point during the study.  It all depends on the study and how it is set up.  They should tell you this during the consent discussion when you're enrolling in the study.

Offline Customer

  • Member
  • Posts: 98
Re: Question about Placaebos
« Reply #4 on: October 05, 2007, 02:05:50 PM »

In the future, it will may be a problem, in HIV studies, that people receiving placebo will find out about it.
If you find out you are on placebo, and you decide to cancel the trial on your part, tell about your decision to the doctors. Otherwise the scientist are prone to make false conclusions. The information that you quit the placebo is important to the doctors.

Valid scientific conclusions can be made without placebo control group. Placebo is helpful, alllows more accurate results, but placebo is not imperative for scientific study. A research group estimating the effect of a drug, could for instance compare the disease progression of test group to a group of people receiving knowingly other medicines, or people knowingly off HAART.  Placebo is nowadays considered almost "a must", even if it is not, and sometimes people are put to risk on basis of placebo experiment. Therefore alternatives to placebo should be always considered. Obviously the "rotating campaing" mentioned by whizzer is an alternative, but requires long test-duration. One possibility would be to offer all the participants the option of receiving optimized dose of drug afterwrds, in the case they were selected to placebo group. This would reduce disappointments.




Online emeraldize

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Re: Question about Placaebos
« Reply #5 on: October 06, 2007, 09:22:44 PM »
Weren't the questions...

When you are a part of a study do you ever find out if you were given a placaebo or not? If you quit the study before it ends do you find out and do you find out if you had the placaebo if complete the study?

?

Offline HIVworker

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  • Posts: 918
  • HIV researcher
Re: Question about Placaebos
« Reply #6 on: October 06, 2007, 09:32:16 PM »
Yes, when you finish a study you find out what you were on.

R
NB. Any advice about HIV is given in addition to your own medical advice and not intended to replace it. You should never make clinical decisions based on what anyone says on the internet but rather check with your ID doctor first. Discussions from the internet are just that - Discussions. They may give you food for thought, but they should not direct you to do anything but fuel discussion.

Offline Esquare

  • Member
  • Posts: 237
Re: Question about Placaebos
« Reply #7 on: October 07, 2007, 04:18:53 AM »
Yes, when you finish a study you find out what you were on.

R

Ok good deal. I was hoping that was the case. All I am trying to do is gather some more information on how the studies work. I really appreciate all of those people that have been a part of a trial study on a drug.

Offline flip408

  • Member
  • Posts: 21
Re: Question about Placaebos
« Reply #8 on: October 10, 2007, 03:14:22 AM »
I am in the 5202 ACT.  I am on the arm with Norvir, Reyataz and either Truvada or epzicom.  Of course its a double blind study, my research nurse, doctor and I don't know which one it is.  Its kind of fun to do investigative work to figure it out.  I think I'm on Truvada, because I had a lot of gas when I started, a lot of general itchy scratchy, and slightly elevated triglycerides.  My reaserch nurse didn't want to guess, she says she's always wrong.  My doctor thinks its epzicom, though I really havn't figured out his theory.  I am pretty sure the protocol calls for disclosure if you have some kind of side effects that are intolerable, drop out of the study for some reason or the study ends (so you know what to continue with). 
Start where you are, use what you have, do what you can.    A Ashe
05/14/11  501  <50  20%
4/14/11  483  <50  19%
2/10/11    523  <50 18% start Rilpivr/trvda
11/15/10  470  <50
1/6/10    430  <50  16%
7/13/09  345  <50  12%
1/26/09  347  <50  16%
7/22/08  306  <50  6%
11/26/07 238 <50  8%
6/11/07  253  <50  5%
11/9/06  122  <50 7%
9/05/06  <25 >100000  PCP

Offline Tim Horn

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  • Posts: 799
Re: Question about Placaebos
« Reply #9 on: October 10, 2007, 12:02:08 PM »
One thing I'd like to point out is that, in most (but not all) studies evaluating an experimental antiretroviral, volunteers are usually provided with much more than just a placebo (at least in industrialized nations). Back in the old days, when drugs like Retrovir (AZT) and Videx (ddI) were being developed, the only option was to compare the effects of the drug to placebo... meaning that a sizeable number of volunteers in the study went without any treatment whatsoever.

Today, things are a bit different. In most Phase II and III studies involving treatment-naive patients -- study volunteers beginning therapy for the first time -- the experimental agent will usually be combined with two standard drugs and compared with a three-drug regimen consisting of the standard-of-care. For example, a new drug will be combined with, say, Truvada (tenofovir plus emtricitabine) and compared to Sustiva (efavirenz) plus Truvada. This way, researchers can get a real sense as to how the drug compares with current options... not to mention keep things ethical.

When it comes to testing new agents in treatment-experienced patients, a placebo may be used... but, again, it is almost always combined with an approved combination of drugs. In this case, the combination is often referred to as "optimized backround therapy (OBR)", consisting of drugs that have been individualized based on a patient's drug resistance testing results and treatment history. So, a novel agents will be combined with OBR and compared to a placebo plus OBR. And the OBR used in the placebo, or control, "arm" of the study reflects the best options currently available. While this may not be ideal for a significant number of patients enrolled in the study, it's not unethical.

There's a much greater "risk" of receiving a placebo -- without other medications -- in Phase I or early Phase II studies.  These are necessary to determine, quickly, if the experimental agent offers any promise and to determine if it should be explored in more advanced Phase II and III studies. Of course, there are still Phase II and III studies come about that don't provide adequate treatment coverage to those randomized to placebo or another type of study control arm. And these studies are frequently shot down by treatment activists and ethical researchers.

Even if you stop receiving medications in a study, you'll probably be asked to remain a participant. Even if you've switched to a regimen under the care of your own doctor, the study researchers may still want to examine you and draw blood from time to time to see how you're doing -- this also provides a lot of information. And by remaining in the study -- or at least in contact with the study investigators -- you'll learn if you were on the active drug, or in the control arm, once the study is "unblinded," although this may not happen until the study has been conducted for at least a year. Only patients who are "lost to follow up" -- meaning that they totally dropped out of the study or failed to remain in contact with the study investigators -- run the risk of never finding out if they were in the treatment or control arm.

Tim Horn   
« Last Edit: October 10, 2007, 12:13:00 PM by Tim Horn »

 


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