The response to those who complain about clinical trials

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they thought if they could demonstrate their drug was effective in patients failed by all known treatments – including ipilumimab – they might be able to develop the drug in a single arm trial – without a comparator arm. While normally drugs need to demonstrate superiority to placebo or to standard of care, patients who have been failed by all existing options by definition have no viable alternative. A new medicine that demonstrates compelling success in such a population might garner rapid approval .