Circumstances that placebo may be incorporated in paediatric IBD trials
| Add-on to an effective treatment | As an add-on treatment to an effective treatment. Medications commenced prior to the trial and allowed to be continued after randomisation cannot usually be considered ‘effective’ since they have typically failed by the virtue of the need to start the study drug. |
| No prior adult trials | In trials of drugs without prior adult approval so there is equipoise about the efficacy of the product under investigation; the use of placebo may be justified if all approved medical treatments have been exhausted and the child is in remission at the time of randomisation to placebo following open-label induction. Complete clinical remission should be the minimum standard. This may be used in a randomised withdrawal trial in which children are randomised into placebo following several months of treatment with an effective drug (rather than few weeks’ induction). |
| No other valid alternatives exist | In rare circumstances placebo may be considered in active patients, such as when no other approved or off-label alternative drugs are available and the patient is in stable non-severe condition. |