FDA looks beyond balance in study of efficacy info
The agency gave notice in a June 16 Federal Register post of a study looking at the presentation of clinical efficacy information in professional labeling and print ads.
“Beyond the balance requirement, limited guidance and research exists to direct or encourage sponsors to present benefit claims that are informative, specific and reflect clinical effectiveness data,” said the notice.
The study will look at how presentation of clinical effectiveness information affects both consumer and physician perceptions of safety and efficacy, “and particularly, how consumers make (risk/benefit) judgments in response to variations in the efficacy presentations in the ‘display' page of a DTC print ad.”
The consumer portion of the study, featuring display pages for fictitious overactive bladder and benign prostatic hyperplasia drugs, will test perceptions of treatment versus prevention claims, placebo data and framing, using “mixed framing,” which provides the number of people who did not benefit from the drug as well as the number who did, as well as the single, positive frame typical of data presentation in drug advertising.
“Only a few studies have actually measured this missed approach, although risk communication guides recommend the use of mixed framing to create more accurate perceptions,” said the notice.
The physician portion will examine physician perceptions of clinical efficacy information in the prescribing information using varying claim types and placebo rates for the fictitious OAB and BPH drugs.
A public comment period on the study is in effect through August 16.