How many deaths prove a drug is significantly unsafe?

April 30, 2010

So a clinical trial designed to study safety shows that a treatment produces significantly more death and survivable complications is presented to a group of people with several hundred patients. In the group with no treatment there was a 25% complication rate and with the group getting treatment there was a 75% complication rate. However, the mortality between the two groups was higher in the treatment group, more people died, but those numbers were not statistically significantly different. Because the complications were more frequent, but considered manageable, and the mortality did not reach statistical significance more people are going to be treated. A lot more people with a much larger clinical trial. (MedCity News)