2 ms·
They already do this. It’s not unusual to add “treatment arms” to a study. However, that still wouldn’t be enough. This was a single arm uncontrolled study.
by refurb 4y ago
They already do this. It’s not unusual to add “treatment arms” to a study.
However, that still wouldn’t be enough. This was a single arm uncontrolled study. No control arm, every patient knew they were getting treatment as did the doctors.
And since you need to pre-define your study design and endpoints, you’d basically need a more rigorously designed trial to actually get approval.
But all this is intentional. You start with quick, cheap studies to see if it’s worthwhile spending more.