http://seekingalpha.com/article/256697-why-phase-3-trials-fa...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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