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The gist of it:

-58% acceptance rate for small molecules
-50% of failures demostrated lack of efficacy AGAINST PLACEBO
-30% were for safety concerns
-20% were not safer or more effective than current SoC

-qualitative endpoints failed more than defined endpoints
-novel mechanisms fail twice as often.
-novel mechanisms and less objective endpoints fail 70% of time.

-8% of oncology meds that GET PAST phase 1 pass.
-good guideline: progression free survival as primary endpoint, inclusion of biomarkers, and incorporation of newer designs."

my take home:
-look for second generation drugs with easier dosing
-for cancer meds after phase 2, look for survival rates & biomarkers
-consider shorting novel mechanisms with odd endpoints.
-ferret out efficacy by looking for the aforementioned P2 guidelines; dump those with high safety concerns; compare safety/efficacy to standard of care.
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