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Evidence Tier Framework Tier 1 FDA-approved therapy large randomized trials Tier 2 human trials demonstrating biological effect Tier 3 small human studies or limited clinical data Tier 4 animal models or anecdotal reports Stacking should generally involve: at least one Tier 1 therapy no more than one Tier 3 compound Stacks composed entirely of Tier 34 compounds should not be considered clinical protocols

ACS Omega 5:2795327961

And, by the time the next Barbie drug reaches the mainstream, it may already be too late to call it experimental

Konopleva M, Tsao T, Ling X, Kojima K, Watt J, Mak DH, Verhaegen M, Bornmann W, Soengas M, Andreeff M