Bear this has bothered me since the very beginning. I always wondered why the company was “forced” to include  atorvastatin in their study. The FDA/EMA requiring this sub group to be part of the trial is equivalent to someone’s mother insisting they take their kid brother to the party with them (only with much greater potential for an undesirable outcome). I agree that this could make a significant difference in the end result of the trial. 

Nike: Our company wants to run a study on how high athletes can jump while wearing these new shoes we designed.

Marketing Group: Okay, but half the participants must be paralympic athletes, because it would be unfair not  to include them. 

DND