I've been searching high and low to find a reason why we may get poor results ( eg published papers why phase 3 fail) given the ongoing extension etc. Can only come up with a few. Must be other potential Black Swans - Anybody got one?
1. Control arm doing as well as study arm
2. Study design flawed
3. Sudden, heinous toxic side effects
4. Data from Eastern Europe not robust
5. Over optimistic management
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