Over-the-counter drugs and direct-to-consumer genetic tests need to stand alone: here’s how the FDA ensures label comprehension.
At SoundRocket, we have spent some time talking about the #SoundScience that is associated with FDA user comprehension studies. These studies are designed to ensure people who have direct-to-consumer (DTC) genetics tests for medical purposes, such as genetic health risk (GHR) or pharmacogenetics tests, can understand the meaning of their results on their own (i.e.: without a healthcare provider) based on the materials provided.
User comprehension studies emerged in recent years associated with marketing authorizations for DTC tests at the FDA, however, they are simply an evolved version of a familiar evaluation study referred to as a label comprehension study.
Label comprehension studies have been conducted for decades to ensure that inserts (i.e.: labels) for nonprescription (i.e.: over the-counter) drug products include clear information on safe and appropriate use, which can be “read and understood by the ordinary individual” on their own. To measure this, comprehension is evaluated in individuals with normal literacy and those with low literacy.
In 2010, the FDA issued a guidance document, which provides specific recommendations on how to implement label comprehension studies. In it, they address general principles regarding study design, objectives, population makeup, and statistical considerations and data analysis.
The document reviews the overall process. Label comprehension studies begin iteratively, using a combination of qualitative research and pilot testing to refine the drug label and tweak the study questionnaire, in preparation for the larger comprehension study. The larger study uses a combination of quantitative and qualitative data to measure, and ultimately prove to the FDA, an acceptable comprehension level.
We use the same phased approach for user comprehension studies.
While the FDA guidance document explores elements of questionnaire design, they caution, it is best to consult experts in questionnaire design when conducting these studies since ‘wording, question structure, and question sequence may significantly affect the validity and interpretability of the data collected’.
With loads of experience in survey methodology and creating questionnaires, this comes easy to us. Stay tuned for a closer look at questionnaire design considerations for label and user comprehension.