What is a Label Comprehension Study?

A comprehensive label development program begins with creating the proposed OTC Drug Facts Label (DFL), usually derived and adapted from Rx labeling, to portray the key indications, warnings and directions, and then testing the language among average consumers in a label comprehension study (LCS; see FDA’s LCS Guidance here).

PEGUS experts utilize many tools to create and iteratively optimize DFL language, including focus groups, early qualitative testing, pilot comprehension studies, and ultimately the pivotal label comprehension studies that support regulatory authority submissions.

In addition to the usual general-population sampling elements in these studies, we aid clients with innovative methods for recruiting important subgroups such as consumers with medical risks or contraindications and low health literacy. We have experience recruiting participants and conducting label comprehension studies across many indications and research settings. This stage of the program may consist of one or more studies:

1. Qualitative or Quantitative Pre-Test: Typically the first stage of label development, these studies provide the first opportunity to gauge consumer reactions to and comprehension of the Drug Facts Label (DFL). They are usually conducted with 10-20 subjects in a single research site, or using a fully remote, decentralized study model (in which participants are recruited, screened, and then interviewed from a distance entirely via technological means). Interviews may be less structured than those for later studies, and changes may be made to the DFL and interview questions in real-time during data collection, based on discussion with the sponsor team. Depending on how the label performs, more than one pre-test may be needed. Goals are to identify and remedy problem areas on the draft label prior to quantitative testing. The extent of this early developmental stage often depends on the length and complexity of the proposed DFL.
2. Pilot Label Comprehension: Often the first quantitative measure of how a draft DFL performs in a label comprehension setting, these studies are typically conducted with 75-150 subjects, in a retail setting (usually shopping malls) with intercept recruiting, at 2-4 sites, or remotely via technology. On occasion more than one version of the DFL may be tested to provide insight regarding various options. Additional pilots are sometimes needed. The goal of this type of study is to ensure the draft DFL is ready for final testing, prior to investing the resources a pivotal comprehension study requires.
3. Pivotal Label Comprehension: This is the definitive quantitative test of proposed DFL language. Typical samples may include 400 or more participants, in multiple physical sites around the country, or remotely via technology. Goals are twofold: 1) to obtain label comprehension data for submission to FDA or other regulatory authorities in support of the OTC switch; and 2) provide reassurance that the DFL is ready for testing in the next study type (where applicable).

If you have questions about how PEGUS can assist with label comprehension research for your product, please click here or call us at 801-990-6126.