Table 1 Ethically acceptable use of Placebo
From: Framework conditions facilitating paediatric clinical research
References | Ethics of placebo-controlled trials |
|---|---|
[36] | 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. |
[10] | 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 |
[36] | When the commonly used therapy is of questionable efficacy. |
[36] | When the commonly used therapy carries a high frequency of undesirable side effects and the risks may be significantly greater than the benefits. |
[36] | When the placebo is used to identify incidence and severity of undesirable side effects produced by adding a new treatment to an established regimen. |
[36] | When the disease process is characterized by frequent, spontaneous exacerbations and remissions and the efficacy of the therapy has not been demonstrated |