For 35 years, PEGUS has been a true innovator in OTC-switch research. The model we developed for pharmacy-based actual use research is now the industry standard. We continue to push the boundaries of new methods and technical tools to help solve complicated problems for innovative OTC candidates. Take a moment to explore our services and learn how we can help with your individual OTC program needs.
Our Services
OTC Switch Consumer Behavior Studies
Consumer Behavior Research for Rx-to-OTC Switch
The FDA customarily requires three basic consumer behavior study types for Rx-to-OTC switch:
Depending on characteristics of the candidate product not all types may be required, and some study types might be blended or combined to address specific program objectives. Additionally, if the product is a drug-device combination, the FDA or other regulatory authority might require:
This last study type broadly conforms to FDA guidance, but in some cases also incorporates elements from the other consumer study types above (such as when self-selection, label comprehension or knowledge-based assessment questions are included to ensure key labeling elements are performing as intended).
PEGUS scientific consultants provide expert advice on all facets of the consumer behavior research programs for OTC switch, including:
- Clinical development plans, including identification of key clinical and regulatory issues specific to the product.
- Regulatory authority meetings and strategy.
- Comprehensive Drug Facts Label development, as well as ancillary packaging and educational materials such as consumer information leaflets (CILs) and instructions for use (IFU).
- Design of protocols, data collection instruments, and supporting materials.
- Conduct, analysis, and reporting of all consumer studies.
Click to learn more about our International Consumer Behavior Study Services.
Remote or “Decentralized” Consumer Studies
PEGUS believes the true value of consumer research is realized through careful, interviewer-mediated data collection – the kind that allows for flexible probing and in-depth exploration of reasoning behind consumers’ answers. While physical sites are used in many studies, the FDA and other regulatory agencies have acknowledged the value of remote and decentralized research to recruit and enroll participants wherever they are – at home, at work, or in geographic areas without a physical study site.
PEGUS enthusiastically agrees, and we have proven methods to connect with consumers remotely and conduct the same high-quality research without the constraints of traditional site-based recruiting and interviewing (see our “Decentralized Clinical Trials” page for more information). Whether you’re looking toward label comprehension research (like focus groups or in-depth qualitative or quantitative testing), self-selection testing, or fully remote actual use or RWE studies, we have the tools and techniques to assist you.
