Recently, the United States Food and Drug Administration (FDA) announced its Office of Prescription Drug Promotion (OPDP) plans to conduct a study to determine how factors like information source, graphic presentations, and time influence a physician’s interpretation of information about prescription drugs presented in scientific journals versus promotional materials. According to the Notice, OPDP will also look at how the level of methodological rigor of the underlying data impacts interpretation of information.
FDA plans to conduct a small pre-test of the study with 158 voluntary participants before moving on to the main study, where the agency plans to enroll a total of 566 voluntary participants. FDA will limit participation to board-certified internists.
The study will use mock sales aids (with and without graphical presentations) and medical journal abstracts with either high or low methodologic rigor “to examine the potential differences in perception that may arise by presenting the same information in different vehicles.”
To define low levels versus high levels of methodologic rigor, FDA will use criteria developed by Aaron Kesselheim, MD, JD, MPH. The criteria will include whether the study was blinded or open label, whether the population is representative of the patient population, and whether safety data was reported. Kesselheim previously conducted research that looked at impacts of study quality and funding source on physician perceptions using the criteria, which resulted in findings that indicated physician participants were able to distinguish between levels of methodologic rigor. That study also found that physicians reported less willingness to prescribe the drugs or read the full study from trials that were funded by industry, regardless of study rigor.
OPDP plans to test three different contextual presentations of drug information (medical journal abstract, sales aid without graphic design elements, and sales aid with graphic design elements), and two types of study methodological rigor used by Kesselheim. The agency expects to test a mock sales aid presentation and a medical journal abstract to examine the potential differences in perception that may arise by presenting the same information in different vehicles. Mirroring the time constraints of practicing physicians, we will examine the role of time pressure by randomly assigning half of the study participants to a limited amount of available time to read the materials.
In order to test how time constraints impact how physicians interpret the materials, FDA says it will randomize the study into two groups: one that is told they have two minutes to review the materials and one that will be told they have unlimited time to review them.
OPDP is hoping that through the evaluation of advertising features, it will be able to assess how elements such as graphics, format, and disease and product characteristics impact the communication and understanding of prescription drug risks and benefits. Further, in the Federal Register notice, FDA notes that by focusing on target populations, the agency will be able to evaluate how understanding of prescription drug risks and benefits may vary as a function of audience.