Regulators at the US Food and Drug Administration (FDA) are planning to conduct a study on consumers' understanding of composite endpoint scores used in direct-to-consumer (DTC) advertising.
Composite scores are essentially a collection of clinical endpoints combined into a single overall score. An allergy drug might, explains FDA, use a composite score that measures a patient's runny nose, congestion, nasal itchiness and sneezing.
Do Consumers Understand What a Composite Score Is?
The study, announced in a 22 August Federal Register posting, is intended to assess whether patients understand that though a drug may have a better composite score than a competitor's product, it is not necessarily better in every single area reflected in its composite score. For instance, one hypothetical allergy drug might have a higher overall composite score, but its competitor could still be better at treating a patient's nasal congestion.
"Because most DTC prescription drug ads do not explicitly state that they used composite scores to demonstrate efficacy or they provide little explanation of how these scores are calculated, it is also important to understand whether consumers recognize how composite scores are used for measuring drug efficacy," FDA wrote.
The agency acknowledged that prior research in the area is "scant," and its own preliminary research found that public knowledge of both the term and its use was minimal at best. When FDA informed its study group about what composite scores were, it said participants fell into one of two groups: those who said they would appreciate drug advertising including information about the composite score, and those who felt that the ads already provided sufficient information to inform their choices.
Under its newly proposed study, FDA said it plans to explore whether consumers are aware of how a drug's efficacy is measured, whether they understand a composite score, whether advertising that uses a composite score skews a person's perception of a drug and how different presentations of a composite score might affect a consumer's perception of a drug.
Composite Scores 'Like a Decathlon'
These questions will be split into two separate studies, FDA said. The first will involve a 1,600-person Internet survey assessing understanding of composite scores and what they mean for a drug's safety and effectiveness, with a particular focus on patients who may not be well educated. The second study will involve 1,602 subjects and will include three different presentations of information: an ad with no information about a composite endpoint, a list of symptoms treated by the drug that make up the composite endpoint, and an explicit definition of a composite score.
Half of the group will also be given an educational intervention, which FDA said should allow it to see if consumers receiving a plain explanation of the information from a presenter effects comprehension of the score. FDA said it plans to use the example of a decathlon to illustrate the concept for study participants.
"In that event, athletes compete in 10 events, such as the long jump, the shot put, and the 50-yard dash. An athlete may not win all events, but if he or she wins some and performs well enough in others, he or she may be the winner based on a combination of scores for each event," explained FDA.
The study is expected to take 1,519 hours to complete. No information about its anticipated start date was provided.