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Re: Trial design alexandra_k

Posted by ed_uk2010 on February 16, 2015, at 14:36:41

In reply to Re: Trial design, posted by alexandra_k on February 16, 2015, at 13:23:50

>I'm shocked about all this talk of minimising placebo response in trials, honestly.

I do understand why, but.... part of the problem with recent drug trials in psychiatry is that they are too 'lush'. This is temporarily good for the participants, no doubt, but bad for the millions of people who then go on to take (or not take) the drug based on poor quality evidence. Minimising placebo responses in clinical trials gives a more accurate picture of what the drug itself is actually doing... or failing to do... as the case my be. Good quality trial data leads to a better understanding of the drug's effects.... very valuable information for psychiatrists and hence patients alike. The fact that participants are provided with an unusually large number of consultations appears to increase the placebo response so much that the trial is no longer of much scientific value - which is indeed a problem!

You might say that this shows we need to spend less on new drugs and more on providing a good therapeutic environment, which should include frequent consultations. That would be a good point. The problem is that patients in clinical trials are not very representative of the 'average' person visiting a psych. This is due to the complex entry criteria which clinical trials employ, sometimes out of necessity. The result may be that those selected are more responsive to placebo that the 'average' pt who has more complex problems eg. including suicidal behavior, which would normally prevent trial entry, for example. Many people visiting a pdoc have already tried several meds from their GP over a period of many months, and not improved.... this removes a lot of placebo responders from those who see pdocs. As a result, psychiatrists really do need to know which meds work better than placebos.

>But, honestly... I don't want my medications to be better than those ineffective placebos. I want my medications to be better than the best placebos money can buy! I mean... Placebo's are pretty effective... Done well... Probably more effective than standard meds.

Once trials have been done on those little weight tablets, companies can go to all the effort they like to make their products better placebos. Fancy packaging, attractive branding, advertising, nicely designed capsules (!) etc etc.

>Not by YOUR talk of it, because I know that you are just informing me of 'standard talk'...

I am, yes, but it does have a purpose for pdocs and those who see them. It's not just a case of benefiting the manufacturers! We all need accurate information of the effects of meds.




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