Doc...thanks for grounding all of us in the reality of dealing w/regulatory bodies during times of change. Can you say ,in this context, how the new "precision Medicine" trials rules are being developed/applied. Are these guidance or are they requirements being applied to the first trials and how is RWE being treated? If new learning occurs which change the trial plans, do they stop/go back and restart or evolve as they go? TIA
How does an enterprise establish a IND protocol with these process controls in place?