Do Consumers Understand TV Ads For Oncology Drugs?
Executive Summary
US FDA plans to conduct a study to evaluate consumer comprehension of oncology indications in direct-to-consumer television advertising.
As oncology products are increasingly being promoted in television advertisements, the US Food and Drug Administration plans to study consumer understanding of information presented in the ads.
The FDA's Office of Prescription Drug Promotion intends to determine whether disclosing information about the nature of the endpoints that support the indications for oncology products helps consumers understand the drug's efficacy. It will also test whether consumers adequately comprehend indication statements when portions of the indication are presented only in the superimposed text of television ads while other information is conveyed in the audio.
The FDA announced the research project, "Study of Oncology Indications in Direct-to-Consumer Television Advertising," in a 21 June Federal Register notice.
"Oncology indications are often complicated and supported by different clinical endpoints such as overall survival, overall response rate, and progression-free survival" that are referenced in the DTC TV ads, the FDA stated.
The agency noted that studying the disclosure of oncology endpoints complements OPDP's research project examining disclosure of information about FDA's accelerated approval pathway to consumers (Also see "Rx Drug Ads: New US FDA Studies Target Accelerated Approval Information" - Pink Sheet, 12 Mar, 2018.) and its research on disclosing oncology information to health care professionals. (Also see "Rx Ad Studies Target Risk Info Location, Efficacy Framing, Oncology Products" - Pink Sheet, 9 Jul, 2017.) The latter article includes a chart of studies then in progress and pending peer review and publication, along with their costs.
13 OPDP Research Projects In Progress
OPDP plans to conduct two main studies. For study one, the office will create two television ads for fictitious oncology prescription drugs to increase the generalizability of the results (one solid tumor indication and one hematology indication). The ads will include audio claims about overall survival, overall response rate with and without a disclosure, or progression-free survival with and without a disclosure.
Participants will be randomly assigned to view one Rx drug TV ad and then complete a questionnaire to assess whether they noticed the disclosure, their retention of the endpoint, and their perceptions of the drug's benefits and risks.
In study two, the presentation of the products' indication will vary so material information will appear in superimposed text only, in the audio only, in both superimposed text and audio, or in neither. The participants will be randomly assigned to view one of the ads and then complete a questionnaire to assess their retention and comprehension of information.
The cost of the research project is $579,824.
To date, the OPDP has completed 33 research projects investigating direct-to-consumer and professional Rx drug advertisements. Five research projects are currently pending peer review and publication, and 13 are in progress, including the oncology DTC ad study.