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Thread: placebo vs non placebo

  1. #1 placebo vs non placebo 
    Forum Junior brane wave's Avatar
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    do you think the concencus is a viable clinical method of research?
    i tend to agree.most research will not inform the patient either way in a test for research(uk).its seems to me,that if the treatment works,it will not be down to the patient,to influence the results(placebo).hopefully,the treatment is fully justifiable regardless of the patients bias.in particular im referring to recent stem cell studies,which indicate,that stem cells can repair problems related to the particular treatment diagnosed,which are being treated for...excuse my ignorence,on this important issue,but its all good as far as real results show...


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  3. #2  
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    Not sure what you want to talk about. The value of placebo controlled trials in stem cell research?


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  4. #3  
    Forum Radioactive Isotope skeptic's Avatar
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    The placebo effect is real, and sometimes powerful. However, is it not better to give a patient a treatment that has real organic benefits, so that the patient gets a placebo benefit as well as a true therapeutic benefit?
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  5. #4  
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    The Declaration of Helsinki states:

    Consolidating on the tenet of safeguarding patient interest further, the declaration explicitly forbids use of a placebo group if an accepted treatment exists. It is mandatory to compare the drug under study to the best available treatment. In any medical study, all patients, including those of a control group, should be assured of the best-proven diagnostic and therapeutic methods.
    However, the FDA and EME will only license novel medications if they have been tested placebo-controlled trials. Leads to some pretty convoluted trial designs trying to satisfy these 2 contradicting positions.
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  6. #5  
    Moderator Moderator TheBiologista's Avatar
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    Quote Originally Posted by Prometheus View Post
    The Declaration of Helsinki states:

    Consolidating on the tenet of safeguarding patient interest further, the declaration explicitly forbids use of a placebo group if an accepted treatment exists. It is mandatory to compare the drug under study to the best available treatment. In any medical study, all patients, including those of a control group, should be assured of the best-proven diagnostic and therapeutic methods.
    However, the FDA and EME will only license novel medications if they have been tested placebo-controlled trials.
    In my experience, most modern drugs trials use a standard of care medication as a comparator. The FDA and EMA are fine with this (also pretty sure the EMA don't give MAs for drugs, they just coordinate functions between local European reg authorities like the MHRA and BFARM which are the ones that give local marketing authorization). This does raise some other problems though- novel drugs need to demonstrate not just efficacy, but superiority (in efficacy or safety) to standard of care. In my view, that's not necessarily appropriate, say if your new drug costs 1/10th that of the standard. It's an imperfect system.

    Placebos are only used for drugs (novel or marketed) where no standard of care exists. Another example, using a specific drug in combination with another drug/medical device when this combination has never been used before- it's ethically okay to have a placebo arm in this case, at least until a clear efficacy signal emerges during an interim analysis. Pharma companies consider that to be a good thing though.
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  7. #6  
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    Yeah, you're generally right about the regulations but there are some interesting caveats; just look at the add-on and emery designs in epilepsy trials. Also, there have been cases where a sub-therapeutic dose of some standard treatment was used as comparison for an agent - making superiority easy to demonstrate. Usually happens in phase 4 trials where regulatory standards don't need satisfying as the drug is already licensed - still can't believe they get it past ethics though. I'll try to find out some specific examples.

    There are also plenty of non-inferiority trials to demonstrate the novel agents are at least as effective as some standard treatment.

    What was this thread about about again?
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  8. #7  
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    The scientific method requires a placebo if you think about it. It's important to know with absolute certainty if your methodology is the cause of a result whether we are talking drugs or psychological studies. Even studies in animals have placebo groups. It sucks for the patient who gets a placebo, especially if the efficacy of a drug seems sound. But I fail to see a better solution until better computer modelling is invented>
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  9. #8  
    Moderator Moderator TheBiologista's Avatar
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    Quote Originally Posted by rossbalch View Post
    The scientific method requires a placebo if you think about it. It's important to know with absolute certainty if your methodology is the cause of a result whether we are talking drugs or psychological studies. Even studies in animals have placebo groups. It sucks for the patient who gets a placebo, especially if the efficacy of a drug seems sound. But I fail to see a better solution until better computer modelling is invented>
    There are a lot of situations in which a placebo group would be unethical as well as unnecessary. If you compare Drug A to placebo and establish safety and efficacy, why not use the same test to compare Drug B to Drug A instead of the placebo? Scientifically nothing wrong with that.
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  10. #9  
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    Quote Originally Posted by TheBiologista View Post
    Quote Originally Posted by rossbalch View Post
    The scientific method requires a placebo if you think about it. It's important to know with absolute certainty if your methodology is the cause of a result whether we are talking drugs or psychological studies. Even studies in animals have placebo groups. It sucks for the patient who gets a placebo, especially if the efficacy of a drug seems sound. But I fail to see a better solution until better computer modelling is invented>
    There are a lot of situations in which a placebo group would be unethical as well as unnecessary. If you compare Drug A to placebo and establish safety and efficacy, why not use the same test to compare Drug B to Drug A instead of the placebo? Scientifically nothing wrong with that.
    I'm not saying that every trial needs to involve a placebo, like in your example of a comparative study, if a drug is know to be safe and to have an effect then there's no need for a placebo group, however all trials of drugs must start with a placebo controlled group if the safety and efficacy is not already established.
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  11. #10  
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    Quote Originally Posted by rossbalch View Post
    Quote Originally Posted by TheBiologista View Post
    Quote Originally Posted by rossbalch View Post
    The scientific method requires a placebo if you think about it. It's important to know with absolute certainty if your methodology is the cause of a result whether we are talking drugs or psychological studies. Even studies in animals have placebo groups. It sucks for the patient who gets a placebo, especially if the efficacy of a drug seems sound. But I fail to see a better solution until better computer modelling is invented>
    There are a lot of situations in which a placebo group would be unethical as well as unnecessary. If you compare Drug A to placebo and establish safety and efficacy, why not use the same test to compare Drug B to Drug A instead of the placebo? Scientifically nothing wrong with that.
    I'm not saying that every trial needs to involve a placebo, like in your example of a comparative study, if a drug is know to be safe and to have an effect then there's no need for a placebo group, however all trials of drugs must start with a placebo controlled group if the safety and efficacy is not already established.
    Absolutely, but I think this is the case.
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  12. #11  
    Forum Junior brane wave's Avatar
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    Thank you all for the responses..most helpful
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