You may be aware that I’ve been going to investigator meetings and finding them kind of out-of-date. We’ve got to get away from what’s easy for the sponsor, and instead move toward what is effective for the investigators and their
To clarify this complexity, I have to step back, calm down, and ask myself a question, such as, “What seems to be the problem?” Then I have to look at the rat’s nest of black wires, and begin the delicate surgery of extricating one wire from the clutches of the other…
Right now I’m sitting in the back of a hotel meeting room near Washington, DC, where two dozen physicians are rehearsing for a presentation to the regulatory authorities. They are debating what point they are trying to prove. The question