Statistical Considerations for Label Comprehension Studies: A Statistical Reviewer's Perspective

• Activity Number: 343
• Type: Contributed
• Date/Time: Tuesday, August 3, 2010 : 10:30 AM to 12:20 PM
• Sponsor: Biopharmaceutical Section
• Author(s): Yan Wang*+
• Companies: FDA
• Keywords: Over-the-counter drugs ; label comprehension studies

Abstract

An over-the-counter (OTC) drug product is required to provide consumers with the information necessary for safe and effective use of the product. To develop an OTC drug product label that meets the regulatory requirement, the drug sponsor often conducts label comprehension (LC) studies to demonstrate consumer understanding of the important communication elements of the label. LC studies are generally open label and single arm studies. Historically, these studies have been primarily designed without pre-defined study goals and with all the analyses done post hoc; thus, the decision about the "success" of these studies relied on whether the label comprehension level was "good enough" to those interpreting the data. Based on the recently published FDA draft guidance on LC studies, this talk will discuss statistical considerations on the design and analysis of these studies.