Actual Use

Concentrics has designed and conducted nearly 30 actual use studies of studies for pivotal Switches, including some of the most recent and complex Switches.  We have conducted nearly 200 consumer use studies for various needs including claims and Phase IV commitments.  We evaluate the needs of the program and then customize the design for your actual use study.  We have conducted a range of studies from small and targeted studies to large-scale actual use studies in special populations.  Most studies range from 500 to 1500 subjects and include a home use period in which the consumer uses the product in an unsupervised OTC environment.

We utilize a variety of research sites from simulated retail environments to actual retail environments and in some cases clinical sites are utilized if clinical measurements are required.  When actual retail environments are utilized, we use our drug/food/mass stores that reflect the settings in which most consumers purchase their OTC products.  We have access to up to 7,000 retail settings, all with pharmacists; 60 of these stores have in-store clinics with nurse practitioners.

While there is currently no FDA Guidance for actual use studies, there are best practices that have been successfully utilized as well as key design principles from existing Guidances for label comprehension and self-selection.

Each program is customized to the sponsor’s goals and needs.  Self-selection can be incorporated into the actual use study or studied in a separate study.  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.