FDA will explain to study participants that just as a decathlon athlete may not win at the long jump, the shot put, or the 50-yard dash but may still be the best overall, a composite score in a clinical trial may not guarantee a drug’s efficacy against any given symptom that is a component of the whole.

FDA expects to see an increase in direct-to-consumer drug comparison ads after the Agency for Healthcare Research and Quality completes its comparative effectiveness compendium.

FDA's Risk Communications Advisory Committee is set to discuss how quantitative risk information can be presented in such a way as to inform rather than mislead consumers.