Regulatory Focus™ > News Articles > 2020 > 1 > OPDP Plots Research on Indication, Endpoint Perceptions in Cancer Drug TV Ads

OPDP Plots Research on Indication, Endpoint Perceptions in Cancer Drug TV Ads

Posted 28 January 2020 | By Zachary Brennan 

OPDP Plots Research on Indication, Endpoint Perceptions in Cancer Drug TV Ads

As more biopharma companies turn to television advertising to showcase cancer treatments, the US Food and Drug Administration’s (FDA) Office of Prescription Drug Promotion (OPDP) is planning new research to better understand how viewers comprehend the treatments’ indications and endpoints.

One study will help OPDP determine whether disclosing information about the endpoints supporting a cancer drug’s indications actually helps consumers understand the drug's efficacy.

For the study, OPDP will create two television ads for fictitious cancer drugs — one for non-small cell lung cancer and one for multiple myeloma — with 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 prescription drug television ad and then complete a questionnaire that assesses whether participants noticed the disclosure, their interpretations of the disclosure, their retention of the endpoint, and their perceptions of the drug's benefits and risks. We will also measure covariates such as demographics, cancer history, and literacy,” OPDP said.

OPDP hypothesizes that without a disclosure, participants will not differentiate between overall survival, overall response rate and progression-free survival. OPDP also hypothesizes that a disclosure will help participants understand the surrogate endpoints (i.e., overall response rate and progression-free survival) and thus will lead to greater understanding of the drug's efficacy compared with conditions without the disclosure.

The aim of a second study is to test whether consumers can adequately comprehend indication statements when portions of the indication are presented only in the superimposed text of the ads while other information is conveyed in the audio.

This study will vary the presentation of the product’s indication, such that material information related to the indication will appear in superimposed text only, in the audio only, in both superimposed text and audio, or in neither.

“Following previous research on dual-modality presentations, we hypothesize that participants who view an ad with the material information in the audio and text will have greater retention of that information than participants in any other condition. We also hypothesize that participants who view an ad with the material information in the audio only will have greater retention of that information than participants in the superimposed text condition and the control condition,” OPDP says.

Federal Register

Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe