Aug. 26, 2019 – How healthcare professionals are influenced by different factors in prescription drug journal abstracts or sales aids – context, rigor of the underlying clinical study and time – is going to be examined by the FDA’s Office of Prescription Drug Promotion (OPDP). In a recent Federal Register notice, the agency stated that it would look at the ways in which information study context, study quality, graphics and time pressure may affect physician perceptions.
The FDA states in the July 19 notice that in prior research, some impacts of study quality and funding source on physician perception have been examined; additionally, a limited review of the prevalence of visual elements beyond text in physician-focused materials have been conducted. The FDA wants to go further then these studies and also wishes to understand how “time pressure can impact processing of information (e.g., accuracy and speed) as well as decision making.”
Indeed, the agency states that existing research has shown “that under time pressure, physician adherence to clinical practice guidelines concerning history taking and advice giving can be compromised.”
The agency proposes 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 with board-certified internists. “We have chosen 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,” the notice states.
Further, “mirroring the time constraints of practicing physicians, we will examine the time pressure by randomly assigning half of the study participants to a limited amount of available time to read the materials.” The study will begin with a pre-test of 158 voluntary participants to ensure that “the manipulations are working as intended, and to examine the effectiveness of question wording,” and then continue with 566 volunteers.
This study of both advertising features and target populations will be conducted as part of OPDP’s research program, as Dr. Kathryn Aikin discussed at the Coalition for Healthcare Communication’s 2019 Rising Leaders meeting. “Although we cannot speculate on any future action because of our research studies, the Agency is committed to examining and conducting research that will ensure that any changes are grounded in science and will have the greatest benefit to public health,” the notice states.