Iron Mike, does it make sense to take years after a trial ends to decide if results are good enough to approve, cost tens or hundreds of millions in documenting the trial when instead the senses of the evaluators could actually be used to see for themselves, speak with clinicians and patients involved. Don't you think their senses would be adequate to say, this is a good thing, Drs. should be able to use it to benefit their patients.
Why shouldn't the experts actually witness what's happening in the field months, or more probably years before they review tons of paperwork documenting it.
I do believe that we have experts making the decisions. I'd hazard to guess that most worked in the field at some point in their careers. I believe they'd know a good thing when the see it, they could query about negative side effects, observe them for themselves. Perhaps after such observations they still want certain things documented, fine, I'll bet it could be knocked down to a few thousand pages, or less. Years and tens of millions could be taken out of the process.
Gary
Bullish
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