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 for two years Also see "FDA's Advertising Studies Expand To Internet Spots, Disease Awareness" - Pink Sheet, 11 October, 2010.. Phase II of that study was designed to ask whether consumers understand clinical efficacy information in print DTC ads, and how to present that information in ways that make it easier for consumers to understand Also see "FDA Advertising Studies Move Forward Along Several Broad Fronts" - Pink Sheet, 2 May, 2011.. Phase III will target physicians.

FDA is now moving beyond the basics of DTC drug ad comprehension to see whether it’s possible to improve consumer understanding of sophisticated concepts about clinical trial design, such as composite endpoints. The agency says it convened consumer focus groups last September and found that consumers did not understand composite endpoints at all, but that when these were explained to them, they looked a lot more skeptically on drug ads that implicitly relied on them, since they now understood that the drugs being advertised might not be effective for a given symptom.

“The focus group findings suggest that research is required to examine how the inclusion of increasingly detailed information affects understanding of composite scores and influences perceptions of efficacy. This is especially important given the many marketed prescription drugs that are based on composite outcomes,” according to the announcement published in the Federal Register Aug. 23.

Two Studies Planned

Both studies will be conducted online. The first study will enroll a general adult population of 1,600 and ask them to “view a print ad that contains claims based on composite scores and respond to questions about the ad to assess whether they recognized that composite scores were used. Other outcomes will include ad comprehension, perceived efficacy, and perceived risk as they relate to their understanding of composite endpoint scores.”

The study will “examine whether and in what ways participants’ perceived efficacy and perceived risk change after they are given a definition and examples of composite scores. Questions will also explore consumers’ understanding of how the effectiveness of drugs is measured in general.”

The second study proposes to enroll 1,602 seasonal allergy sufferers who will evaluate randomly chosen ad formats for a hypothetical seasonal allergy drug that was studied using a composite endpoint. In one ad format, “participants will see the drug indication but will not see any explicit statement that the drug’s benefits are based on a composite endpoint.” In the second format, “the drug indication and all of the symptoms that are used to make up the composite score” will be included. Advertisers often use both of these formats.

The third format “will present the indication, describe that the drug’s benefits are based on a composite endpoint, and explicitly define a composite score,” which FDA believes to be unprecedented. Some participants will also be shown a detailed explanation of what a composite score is, using comparisons such as decathlon athletic events to explain how this works: “Drug A’s effectiveness is based on a composite score. A composite score is like a decathlon. 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.”

The Drug Olympics: FDA To Test Consumer Comprehension Of Composite Endpoints

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