Regulatory Focus™ > News Articles > 2019 > 7 > FDA to Study Physicians’ Interpretations of Drug Information

FDA to Study Physicians’ Interpretations of Drug Information

Posted 18 July 2019 | By Michael Mezher 

FDA to Study Physicians’ Interpretations of Drug Information

The US Food and Drug Administration (FDA) on Thursday said its Office of Prescription Drug Promotion (OPDP) will conduct a study to determine how factors such as information source, graphical presentations and time can influence physicians’ interpretation of information about prescription drugs presented in scientific journals versus promotional materials.
 
The study will also look at how the level of methodological rigor of the underlying data impacts physicians’ interpretation of information.
 
“Through the evaluation of advertising features we assess how elements such as graphics, format, and disease and product characteristics impact the communication and understanding of prescription drug risks and benefits,” FDA writes.
 
FDA says it plans to conduct a smaller pre-test of the study with 158 participants before moving on to the main study where the agency plans to enroll 566 participants. For the study, FDA says it is limiting 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.”

OPDP-Study-Table.png

“Prior research has examined some impacts of study quality and funding source on physician perception,” FDA writes, pointing to research conducted by Harvard professor Aaron Kesselheim.
 
FDA also says it will use criteria developed by Kesselheim to define low versus high levels of methodologic rigor. The criteria include whether the study was blinded or open label, whether the population is representative of the patient population and whether safety data was reported.
 
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.
 
FDA

Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe