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.
Our Services
Consumer Behavior Studies
Rx-to-OTC Consultants
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.
Self-Selection Studies
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.
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PEGUS has a great deal of experience in designing, conducting, analyzing, and reporting self-selection trials, and has a cohort of sites available for conducting such studies. We can help you formulate a self-selection study strategy, including recruitment for low-incidence subgroups, and design and conduct of the studies needed to answer the key regulatory questions regarding consumer selection behaviors for the OTC candidate product.
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).
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In the last few years the Division of Nonprescription Drug Products (DNDP) has begun to make more requests of OTC sponsors to conduct human factors studies when a proposed OTC product requires consumers to do something more than just take a pill (for example, prime a device prior to administering a dose, or correctly spray the product into the nose or mouth in the case of inhalers).
Most clients know the work PEGUS Research does in support of Rx-to-OTC switch and OTC brand line extension programs (including Drug Facts Label development and the design and conduct of label comprehension, self-selection, and actual use studies); however, some may not yet know that PEGUS also conducts human factors studies for OTC combination products to address specific research needs and requests from the Agency. We have supported a number of human factors studies for OTC clients.
If you have questions about ways PEGUS can assist with human factors research, please contact us.
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.
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We think that a study to evaluate safety in real use should recruit subjects in places they really go to get their non-prescription medicines. We, therefore, have developed a network of more than 100 retail pharmacies throughout the country. A subset of those pharmacies is selected to meet the needs of any given study. Other research principles we incorporate in the design of an actual use trial include minimizing obtrusiveness and reactivity (the tendency for the evaluation of behavior to affect that behavior); sizing the subject sample to best meet the needs of the development program; enrolling everyone (within appropriate ethical constraints) who self-selects into the trial (regardless of whether or not they meet the labeled selection criteria); using targeted recruitment methods that as much like natural advertisements as possible in the context fo the research, and use of real drug packaging and a thoroughly tested label.
These principles may seem obvious in the abstract, but the real challenge of actual use research is the application of those principles to a real problem. We are happy to visit you and discuss the science of actual use trials adapted to the context of your specific program needs.
International Studies
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.
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We also have experience in the conduct of label comprehension and human factors studies in the United Kingdom and Germany. These studies focused on determining if average consumers could comprehend the package information and then perform a series of steps as outlined in the package information.
