Human Factors Research Overview
BioTrak Research Inc. has been conducting human factors research involving usability testing and labeling comprehension with patients and health care professionals for over a decade. This experience has included research programs supporting regulatory applications of an inhaled medication, novel patient-administered injectables and topical agents, and new oral dosage forms. In addition, BioTrak has worked on many new types of novel drug delivery technologies and forms to guide sponsors towards optimizing product performance.
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.
Usability studies establish the adherence to label directions and use of the product in an ethnographic setting to determine whether the stakeholder understands when and how to take a medication, or how to properly administer a medication. For example, the actual-use studies determine adherence to the label directions under conditions of actual use and when to contact a healthcare professional (in response to specific warning language). Human factors are often measured in this type of research.