Self-Selection

Concentrics has designed and conducted many customized self-selection and/or self-diagnosis studies. These studies are based on best practices in consumer research and on the FDA’s “Guidance for Industry: Self-Selection Studies for Nonprescription Drug Products” (April 2013).  The study design is based on the needs of the program.

Each program is customized to the sponsor’s goals and needs.  Often the testing begins with pre-testing and proceeds to pilot testing and finally to quantitative testing.  Self-selection testing can be accomplished in a variety of ways including combining the testing with either label comprehension or actual use studies or conducting a stand-alone self-selection study.

Self-Diagnosis

A self-diagnosis confirmation can be added to the design if there is a concern about whether the consumer can correctly identify the condition for which the product is intended.  This testing may involve examinations from medical professionals and/or diagnostic testing as a confirmation to the consumer’s decision-making.

Self-Selection and Self-Diagnosis

If your program requires both self-selection and self-diagnosis testing and confirmations, Concentrics has a novel approach for combining the needs of both endpoints, an S³ Study which combines self-selection, self-diagnosis and a confirmation of both by a medical professional.

Concentrics will work with you to create the design that will best meet the needs of your program and supply the data needed for your defense to FDA or an Advisory Committee.