If a physician doses 10 patients with an investigational drug as part of a registrational trial, does that implicitly bias him for or against that product? If a medical professional with an expertise in a rare disease is a co-principal investigator, should that categorically exclude her from an advisory committee – even if she is one of the few global experts in that orphan condition?
US FDA Advisory Committee Reboot (Part II): The Right Balance For Conflicts Of Interest
After back-and-forth tinkering with CoI restrictions, CDER is still finding it challenging to seat the right experts. Maybe more realistic guidelines are needed.
