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Table 1 Ethically acceptable use of Placebo

From: Framework conditions facilitating paediatric clinical research


Ethics of placebo-controlled trials


When there is no commonly accepted therapy for the condition and the new medical entity is the first one that may modify the course of the disease.


When patients have failed to respond to standard treatment, they might be randomised to a new treatment or a placebo because they have exhausted alternative options


When the commonly used therapy is of questionable efficacy.


When the commonly used therapy carries a high frequency of undesirable side effects and the risks may be significantly greater than the benefits.


When the placebo is used to identify incidence and severity of undesirable side effects produced by adding a new treatment to an established regimen.


When the disease process is characterized by frequent, spontaneous exacerbations and remissions and the efficacy of the therapy has not been demonstrated