Is Placebo Response Responsible for Many Phase III Failures?

The "gold standard" for demonstrating effectiveness of investigational drugs is through randomized, double-blinded, placebo-controlled (R-DB-PC) trials. This assertion is further supported by meta-analyses of antidepressant trials suggesting that high placebo response rather than low medication response explains most of the variability in drug-placebo differences.[3] Recent summaries of placebo and treatment effects for successful drugs in depression[5] and attention deficit hyperactivity disorder[6] have suggested that drug effects also increased over time. Placebome data described in the paper by Hall and Loscalzo[23] further support that the effects of placebo and active drugs are not additive, the tenant of our R-DB-PC trials. [Extracted from the article]