FDA DTC Study Should Use Real Ads, Be More Conversational – AstraZeneca

AstraZeneca is asking FDA to incorporate a more qualitative approach in the initial phase of its planned evaluation of the "brief summary" section of direct-to-consumer print advertising.

"In an optimal world we would recommend qualitative one-on-one interviews for this phase of research, where the goal is depth of understanding of consumer objectives and needs across conditions, education levels and treatment scenarios," the company said.

^FDL-1 AstraZeneca's comments respond to FDA's proposed survey intended to study the effectiveness of the brief summary statement. FDA plans to ask consumers about their impressions of ads for fictitious drug products with either a high or low degree of risk.

"The current research will investigate the nature of consumers' goals when they read prescription drug print advertisements, and the relative usefulness of the information," FDA's ^FDL-2 study announcement states.

AstraZeneca agreed with FDA that it is "appropriate that the current ^FDL-3 questionnaire starts out with a focus on the ad overall, without focusing too quickly into the risk information." However, "if the goal is needs identification, there is a lot of benefit in initially allowing consumer needs and perceptions to bubble up vs. leading with the pre-determined statements."

"If consumers do not actively bring up concerns or issues with the risk information within the context of the overall ad, for instance, that by itself may tell us something about their information needs," AstraZeneca said.

"When it comes time to quantitatively understand how much of the risk information is being read and how much time consumers spend with the ad, there are eye-tracking technologies that can provide more accurate insight into that process vs. self-reporting."

If FDA switches to a qualitative research approach, AstraZeneca suggested the survey use real drug ads instead of the proposed fabricated ads. "We feel we should replicate as real world a situation as possible for these base understanding discussions."

"The current quantitative study assumes everyone is new to the product, which may not represent the breadth of consumer goals. Exploring needs and perceptions using actual ads for actual products across the possible awareness scenarios would be more representative and insightful."

FDA's study would create eight fictional ads for products treating four medical conditions - high cholesterol, obesity, asthma and allergies - to gauge "the full context of the 'side effect, contraindications and effectiveness' information."

Using a mall-intercept protocol, the study would select 432 participants who were either diagnosed or at-risk for one of the four medical conditions, or the caregiver of a person with a condition.

AstraZeneca expressed concern about the sample size. "Without having more detail on the analytic plan," the company said it appeared that the study would only allow for comparisons of the high-risk and low-risk products across all conditions, not within each one.

If the sample size was increased to 1,200 participants, AstraZeneca said, the study could distinguish results within each condition and between the different categories of participants, including level of education.

"We are recommending more segmentation in the education factor," AstraZeneca said. The company argues that FDA's current design is not powered to show differences between groupings of respondents based on education.

The study is one of several the agency is planning to help it finalize a guidance on brief summaries (¹ (Also see "FDA Research Protocols On DTC Brief Summary Info To Be Finalized In Fall" - Pink Sheet, 20 Sep, 2004.), p. 25).

FDA expects the design of the study to change only minimally and hopes to collect the data in eight malls across the country by the end of the summer. The initial proposal for a second study examining content issues involving the brief summary may be released by the end of the summer. A third study on the format is also being planned.

AstraZeneca is among a number of pharmaceutical companies that have announced a new approach to television advertising. The company was cited by FDA earlier in the year for misleading superiority claims in Crestor TV ads. A new spot for the statin recently launched with more direct discussion of risk information (² , p. 12).