What is a Self-Selection Study?

For many OTC switches, the most important regulatory questions revolve around consumers’ ability to correctly select or not select a medication based on their understanding of their own symptoms, medical conditions and medications. The self-selection study (SSS) is, therefore, often crucial to the development program (see FDA’s SSS Guidance here).

PEGUS has a great deal of experience designing, conducting, analyzing, and reporting self-selection studies. We can help you formulate a strategy, including recruitment for low-incidence subgroups, and then design and conduct the research needed to answer the key regulatory questions. Two general types of SSS are:

1. General Population: Self-selection studies differ from earlier label comprehension studies in an important way. Whereas comprehension studies are conducted with average consumers who may or may not be indicated for use of the drug, self-selection studies are specifically targeted to prospective users of the product to see if they can correctly apply the indications and contraindications on the DFL to themselves.
2. The typical self-selection study involves recruiting those interested in a product to treat specific symptoms using “OTC-like” advertising such as postcards mailed to households, or digital/social media ads displayed to consumers in a targeted fashion. Prospective subjects may either self-pre-screen on-line or call a centralized number for initial screening and scheduling, and then present at one of the study sites to participate or may be interviewed remotely via technology. Sample size depends on multiple factors, including sub-groups of interest, but often ranges from 300 to 500 participants. The goal is to demonstrate that participants who should not use the product (as defined by the DFL) appropriately decide they would not select the product, or, when appropriate, would ask a doctor or pharmacist first.
3. In some cases, validation assessments (such as by a clinician) may be used to verify the presence or absence of important symptoms or clinical characteristics for subjects. Formal review and classification of selection decisions is an important tool for contextualizing outcomes based on clinical risk. In some cases, it may be possible to combine the self-selection objectives for a program into an actual use trial, rather than conducting self-selection as a separate study.
2. Special Population (Targeted): In cases where the FDA other regulatory authority might have concerns about appropriate non-selection among a specific group, such as those with contraindicated conditions (particularly where that group might be too rare to capture and represent in a general population SS study), a SSS can be performed among the specific group of interest.

SS studies for technology mediated “ACNU” products may involve additional self-selection procedures that are highly specific to the technology tool that will be used for enhancing correct self-selection. See our “Additional Conditions for Nonprescription Use” page for more information.

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