Lessons From the Placebo Effect: A New Design for Clinical Trials?
This is not easy to explain (at least not for me), so please hang in with me...
As I mentioned last time, the standard design for a clinical trial tests a new drug or treatment against a blank or fake treatment - the placebo. But designing a study that way means that at least some of the participants will not receive the treatment. They will only receive the placebo. Because they are usually 'blinded', they know that they may or may not be receiving the actual treatment, but they don't know whether they are or not. Given that now there is a better understanding of what happens when an individual experiences a placebo effect, there is growing support for changing the way placebos are used in clinical trials.
In this new scheme, participants would all be told they were receiving the experimental treatment. Whether they are given the real or placebo treatment, their bodies (and minds) will react to the thought that they are receiving the treatment. In this way there is a better comparison between the two arms of the study. Why? Because both arms will experience whatever placebo effect is associated with the study. Any differences observed between the two groups can be attributed to the drug or treatment itself. The analysis will not be compromised by the placebo effect because everyone will have experienced the placebo effect.
The problem with this approach is this: Suppose most or many clinical trials are designed in this new way. Everyone is told they will be receiving experimental treatment. It's called 'covert' administration, and it would mean that those who actually get placebo are lied to. This would not break the rules governing human subjects research, provided a) it was necessary to the scientific purposes of the study and b) the study was approved with this design by the Institutional Review Board overseeing the research. I suppose it might make some of us feel better if participants were told after their participation was completed that there actually was a placebo arm. I am anticipating a number of annoyed participants, however...
From a strictly scientific point of view, it is probably better science to design trials with covert administration of placebo. We probably should have been designing clinical trials this way all along. If we can get past the perceived ethical hurdle of deceiving participants, it just might become the standard.
I would love to hear from clinical trial coordinators and others on this issue.
-Joe
Related Topics: Are 'Dummy Pills' a Dumb Idea, or Do They Really Help?, Placebo and sham treatment
Technorati Tags: placebo, clinicaltrials, medicalresearch
As I mentioned last time, the standard design for a clinical trial tests a new drug or treatment against a blank or fake treatment - the placebo. But designing a study that way means that at least some of the participants will not receive the treatment. They will only receive the placebo. Because they are usually 'blinded', they know that they may or may not be receiving the actual treatment, but they don't know whether they are or not. Given that now there is a better understanding of what happens when an individual experiences a placebo effect, there is growing support for changing the way placebos are used in clinical trials.
In this new scheme, participants would all be told they were receiving the experimental treatment. Whether they are given the real or placebo treatment, their bodies (and minds) will react to the thought that they are receiving the treatment. In this way there is a better comparison between the two arms of the study. Why? Because both arms will experience whatever placebo effect is associated with the study. Any differences observed between the two groups can be attributed to the drug or treatment itself. The analysis will not be compromised by the placebo effect because everyone will have experienced the placebo effect.
The problem with this approach is this: Suppose most or many clinical trials are designed in this new way. Everyone is told they will be receiving experimental treatment. It's called 'covert' administration, and it would mean that those who actually get placebo are lied to. This would not break the rules governing human subjects research, provided a) it was necessary to the scientific purposes of the study and b) the study was approved with this design by the Institutional Review Board overseeing the research. I suppose it might make some of us feel better if participants were told after their participation was completed that there actually was a placebo arm. I am anticipating a number of annoyed participants, however...
From a strictly scientific point of view, it is probably better science to design trials with covert administration of placebo. We probably should have been designing clinical trials this way all along. If we can get past the perceived ethical hurdle of deceiving participants, it just might become the standard.
I would love to hear from clinical trial coordinators and others on this issue.
-Joe
Related Topics: Are 'Dummy Pills' a Dumb Idea, or Do They Really Help?, Placebo and sham treatment
Technorati Tags: placebo, clinicaltrials, medicalresearch
5 Comments:
Hi Joe,
Just wanted to say that, as a previous participant in several clinical trials, I would not be offended in the least, nor would I be angry afterwards, if I were informed that a study had been conducted in the manner which you have described.
I'm certain that there would be plenty of study participants who would feel much differently than I do, but you can't please everyone all of the time, right? As long as the trial is conducted in an ethical manner, I think that the pros far outweigh the cons. Clinical trials are, after all, conducted to advance medicine, not to please their participants. (Although, if the study participants receive a benefit during the trial, that is certainly an added bonus.)
Personally, a big part of the reason I have taken part in clinical trials is for the potential that they have for improving future outcomes for other people. I won't say that I've never participated for selfish 'selfish' reasons, but again, receiving a benefit while participating is something I consider a 'bonus'.
Most trials provide some form of compensation to partipants, which in my experience has made up for any 'inconvenience' I may have been subjected to. But again, I take part because I have hope that by participating, someone else might someday be helped by whatever it is that is being researched. The prevention of future dis-ease is much more important to me than are my own current problems. After all, I already have them! But the thought of being able to potentially prevent someone else suffering the same fate is incentive enough for me. (I'm sure I'm not alone in feeling this way, either.)
I just wanted to let you know that I agree with your take, and this comes from someone on the 'other side' of the clinical trials street. Thanks for the informative discussion! I hope to hear more about this idea in the future.
Take care,
gina
Thanks for posting your thoughts, Gina! I appreciate hearing from someone with first-hand experience as a research participant. And, while it sounds as though you already realize this, you ARE contributing to a better future for others. Best of luck to you!
-Joe
Is this truly ethical? Aren't you effectively lying to a patient? Patients are vulnerable and obtaining "informed" consent means just that. Yes, they need to know there are no guarantees of benefit, however in my experience hope of benefit plays a large role in people taking part. You have to bring people down to earth sometimes when they have unrealistic expectations of potential benefit, but it needs to be done in a supportive way.
Joe, Hi, Jmal dotson here. i would like to thankyou for your information on clinical studies, foremost. i too am a test subject for a paticular study. i personally would not be angry if the research center conduct the research in this mannor, it gives the study subject something to research besides their meds they are taking. Now i'm studying each research center i'm involved with.
Joe, Hi, Jmal dotson here. i would like to thankyou for your information on clinical studies, foremost. i too am a test subject for a paticular study. i personally would not be angry if the research center conduct the research in this mannor, it gives the study subject something to research besides their meds they are taking. Now i'm studying each research center i'm involved with.
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