<i>Instead, they say, the standards should take into account the severity of the diseases that the drugs seek to address.</i><p>The FDA already does this.  Take a look at the Duchenne&#x27;s muscular dystrophy drugs currently up for review.  One of them fail to show a statistically significant difference from the control group and the other one only had a single trial of 10 patients.<p>The likelihood is that one or both of the drugs will be approved since no treatments currently exist.<p>Then take a look at diabetic drugs.  Any hint of cardiovascular side effects and the FDA slaps a black box warning on the package and asks for a 10,000 patient follow-up trial.  This makes sense because drugs already exist to control diabetes.<p>This article seems to lay out a more mathematically driven method for statistical testing, but it&#x27;s a bit ingenuous to say this is something new for the FDA.