Labeling Comprehension Studies
Labeling comprehension studies determine if the medical information or labeling clearly communicates the uses, directions, risks and warnings to a diverse population and enables the consumer to make appropriate judgments about acceptable use, safety, and self-selection. Common types of labeling comprehension studies involve testing or assessing a Medication Guide, patient package insert, or instructions for use (IFU). We frequently perform these studies with both healthcare providers and patients in an observational research setting for healthcare provider (HCP) communications and consumer medical information (CMI). BioTrak has extensive experience with labeling comprehension study design and execution. We offer a science-based method of quantifying readability and determining grade level of written content. Some recent examples can be found here.