Avoiding placebo arms in clinical trials - Advanced Prostate...

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Avoiding placebo arms in clinical trials

Darryl profile image
DarrylPartner
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Avoiding placebo arms in clinical trials can be tricky, but there are strategies to improve your chances of getting active treatment. This video breaks down how different trial phases work, which designs typically include or exclude placebos, and how to find trials that offer real treatment. You'll learn about single-arm studies, open-label trials, crossover designs, and expanded access programs. Plus, we’ll cover key questions to ask before signing up, so you can make informed choices about your treatment options.

More information at malecare.org and canceracademy.org

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JohnInTheMiddle profile image
JohnInTheMiddle

Wow! The mind boggles. There are studies showing apparently that medical research study participants on the whole don't benefit as much as one would like to believe. After all studies are studies! Not concierge medicine.

Now we have here a how-to on "avoiding the placebo arm of a trial". I can understand that. One wants advanced treatment, although it's important to remember that any such treatment is some sort of experiment, either as hypothesis generation or to confirm a hypothesis. ("Experiment", as in guinea pig.)

Big randomized control trials of perspective new drug therapies are quite likely sponsored by a corporation, or by an institution that would like the trial to be successful. But the whole purpose of the trial of course is that we don't actually know if the hypothesis is correct. Thus, the placebo or "current standard of care" trial arm. We're going to look at what happens if you take the drug versus what happens if you don't.

In statistics, there is the concept of "p-hacking" - where the researcher keeps squeezing their data until they get the level of significance that justifies their work. The result is meaningless or fraudulent research (see "replication crisis").

Now we have the same sort of thing from the patient's perspective. Maybe we could call this "trial-hacking". Economists call this "moral hazard". Which simply means that the motivations and rewards for participants in some process are not aligned in the same way. If "trial hacking" is possible for a given trial, it's a recipe for corrupted scientific results and exposure of participants to unknown risk.

This is all very entertaining, except I've recently become aware of a real-world result which apparently is derived exactly from the situation under discussion here.

I have noticed in various online and written forums concerning metastatic prostate cancer how the new Pluvicto radioligand therapy is being promoted and enthusiastically received. I would almost call it a situation where ostensibly neutral moderators are actually cheerleading for this hugely expensive and very new almost science fiction therapy. Some say that Pluvicto is almost being oversold.

Why is this relevant in the contact stuff "avoiding the placebo arm" for the "current standard of care arm" or what I called above "trial hacking"? Because apparently early trials of Pluvicto were "open label". So trial participants new which arm of a trial they were in, the real therapy or the placebo or SOC. And a large number of placebo or SOC participants dropped out. And this may have resulted in statistics that were more positive than they might have been otherwise. Pluvicto science is amazing and it might be a great therapy for some people. But it seems that the social enthusiasm for the therapy by lay people is not yet justified.

For participants in this forum, I think this video is excellent. Because you have to get the edge you can get. (Although you should be aware of the risks.) I also am of the opinion that trials of experimental therapies are scary. But then I'm doing okay right now and my back isn't against the wall. How research could be better conducted where moral hazard is not such a problem and motivations and benefits were better aligned between research participants would be a great thing.

(Edited a few times...)

LifeQuality profile image
LifeQuality in reply toJohnInTheMiddle

Excellent response, JohnITM

cigafred profile image
cigafred

Does not give guidance on avoiding the placebo arm (and for a valid trial choice cannot be possible), only discusses choosing trials without a placebo arm.

GP24 profile image
GP24

In prostate cancer there are almost no trials with a placebo arm but with a standard of care arm as the control arm instead. Therefore if you are randomized to the control arm you get the treatment you would get if you would not take part in the trial. The control arm is also very important and essential for the trial. You should not drop out if you think you got into the control arm.

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