The Drug Olympics: FDA To Test Consumer Comprehension Of Composite Endpoints
• By Martin Berman-Gorvine
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 says it plans to use the analogy of an athlete competing in a decathlon in planned studies of consumer understanding of composite endpoints in clinical trials used to support drug efficacy claims.
The agency has been considering studies of how consumers and physicians understand the information in printed drug labels and advertisements...
