Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at email@example.com if you need assistance.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
The RAPS store will be under maintenance 15 January 2022 from 5 AM to 1 PM EST. Store functionality may be unavailable during this window.
We apologize for any inconvenience caused during this time.
Posted 27 May 2014 | By Alexander Gaffney, RAC,
The US Food and Drug Administration (FDA) has put the finishing touches on a proposed eye-tracking study intended to assess how patients assess the benefits and risks of direct-to-consumer (DTC) drug advertising when subject to on-screen "distractions."
FDA has conducted similar research in the past, it notes in its 27 May 2014 Federal Register announcement. Prior eye-tracking research determined that consumers understand drug risks better when they are simultaneously displayed on screen and spoken by the narrator of the advertisement. Other, separate (but related) research also determined that consumers were not confused by the addition of information on how to contact MedWatch to report side effects associated with the use of the advertised drug.
But FDA says it's now interested in studying how consumers might react to an advertisement that contains both variables, as well as how "potentially distracting images and sounds" might affect risk recall.
"Previous research has shown that factors such as multiple scene changes and music in advertising can be distracting," FDA wrote. "The effects of distraction during the major statement of risks on consumers' perceptions and risk recall have not been tested in the presence of risk-reinforcing superimposed text."
To assess this, FDA says it plans to conduct an eye-tracking study "to determine how superimposed risk information and the MedWatch statement are perceived in DTC ads and also the impact of distraction," allowing regulators to determine if a participant is actually paying attention to the intended information.
"We hypothesize that distracting audio and visuals during the major statement will decrease risk recall, risk perceptions, and attention to superimposed text risk information," FDA explained.
The two-phase study will involve a 30-participant pilot, followed by a 300-participant main study. Participants will be those who self-identify as wanting to lose more than 30 pounds and are at least 18 years of age. The study will focus on a fictitious prescription weight loss drug, and split patients into two groups: One with "low" levels of distractions, and another with "high" levels of distraction. FDA said these advertisements have already been developed and pre-tested. (Note: The Federal Register notice has all the technical details associated with the study, which are extensive.)
The study was first proposed in November 2013, and is at least the second study in three years to focus on obese patients.
The finalized study plan is now subject to a 30-day comment period, after which time it will be sent to the Office of Management and Budget (OMB) for approval.
Eye Tracking Study of Direct-to-Consumer Prescription Drug Advertisement Viewing
Tags: DTC, Advertising, Study, Eye-Tracking Study, Obesity, Distractions
Regulatory Focus newsletters
All the biggest regulatory news and happenings.