For nearly 30 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.
Consumer Behavior Studies
The senior consultants at PEGUS provide expert advice on all facets of the consumer behavior research programs for OTC switch:
- Clinical development plans, including identification of key clinical and regulatory issues specific to the product.
- FDA 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.
- Design of protocols, data collection instruments, and supporting materials.
- Conduct, analysis, and reporting of all consumer studies.
Label Comprehension Studies
A comprehensive label development program starts with a careful evaluation of the effectiveness of the proposed Drug Facts Label (DFL) in driving appropriate comprehension (see FDA LCS Guidance here). PEGUS experts utilize many tools to measure comprehension and refine the draft label language, including focus groups, one-on-one qualitative interviews, quantitative pretests, pilot comprehension studies, and ultimately the larger pivotal comprehension studies that support the submission. In addition to the usual general-population elements in these studies, we also aid clients in developing studies with innovative methods for recruiting special subpopulations including contraindicated risk groups and consumers with low health-literacy. We have experience with recruiting participants and conducting label comprehension interviews across various different research settings.
For certain OTC switches, some of the most important regulatory questions are those concerned with consumers’ ability to make an appropriate decision about the suitability of the drug for their own use. The self-selection study is an important, often crucial, phase of label development.
Self-selection trials differ from label comprehension studies in important ways (see FDA SSS Guidance here). The nature of the respondent sample, naturalistic research setting, and the questions that are asked are designed to evaluate how potential OTC users of the drug will use the label in their selection decision.
Human Factors Research
For years the FDA has requested device and prescription drug manufacturers to conduct human factor studies, sometimes also referred to as usability studies. In contrast to label comprehension studies, which assess the extent to which consumers understand the information on drug product labeling, the intent of human factors research is to evaluate the user interface of a product, or in other words the ability of users to follow and actually perform the needed instructions in a way that eliminates or mitigates potential use-related hazards. In February of 2016, the FDA issued guidance on how to conduct these studies for combination products (e.g. products comprising of both a drug and a device).
Actual Use Trials
A key question that must be answered in an OTC switch program is whether potential users of a new OTC product can appropriately self-diagnose the condition the drug treats, make a correct self-selection decision based on the label, and safely use the drug without medical supervision for its intended purpose. These are questions that can only be answered by an actual use trial. The design principles for the conduct of high-quality observational trials are quite different from the principles of experimental trial design. However, these two approaches to research do not conflict with each other-observational studies are the best vehicle for evaluating real-world safety, whereas experimental trials are necessary to assess efficacy.
PEGUS Research has significant experience in supporting OTC products, switch efforts, and other studies in the EU.
We conducted the first Actual Use Trial for the successful OTC/GSL switch of a product in the UK. In early 2015, we completed a self-selection study in the UK and Sweden utilizing a network of pharmacy sites. This study supported the UK approval of a non-prescription product for a novel indication.