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February 19, 2012 no comments

Avoiding the pain of the not-so-mystical placebo effect with the almost-magical run-in period

Nothing kills biotech companies like an active placebo.  More often than not the press release after a failed trial points the finger at a “surprisingly large placebo response” against which the active drug had little scope to excel.

It’s easy to assume that this placebo effect has its origins in some almost mystical neuropharmacology, where simply believing you are being treated with a powerful new drug is sufficient to induce a miraculous recovery – and as a result that there is little you can do to mitigate against the effect.

But in reality by far the largest proportion of the placebo effect originates from the design of our clinical trials, and can be readily neutralised by careful adherence to a few simple principles.  The first step to eliminating the avoidable failure that comes from high placebo response rates is to recognise that it’s not in the lap of the gods – but in the hands of your Chief Medical Officer.   All you need is the almost-magical power of a run-in period.

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