Wondering how to keep your OTC consumer behavior research program on-track in the face of COVID-19?

The world is changing, and while the global COVID-19 “lock-down” is hopefully just temporary, it’s clear that average consumers in the US are not eager to participate in in-person research at traditional sites under these circumstances. That can threaten the progress of planned or existing OTC-switch and other consumer behavior research programs.

PEGUS can help. We have been working aggressively on tools and methods to connect with consumers remotely and conduct the same high-quality research without the constraints of traditional site-based recruiting and interviewing.  Whether you’re looking toward label development research (like focus groups- or in-depth qualitative or quantitative pre-testing), self-selection testing, or fully-remote RWE or actual use studies, we have the tools and techniques to assist you.

Label Development Research

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. The question is how to maintain this detail and rigor in a world where many or most consumers may be shuttered at home.

Many label development (label comprehension) studies can be conducted remotely. These are proven methods we are already using at PEGUS right now:

• Outbound telephone recruiting (from existing market research panels and databases)
• Social media/digital advertising to expand reach and geographic diversity
• Telephone (or online audio/video interface) for data collection
• Online stimulus display (electronic display of consumer-friendly packaging and labeling)

Our trained, in-house interviewers are skilled at engaging with consumers to collect detailed information remotely. These studies can be small and informal (with data collected into simple electronic files for rapid analysis) or larger and formal (with a 21 CFR Part 11-compliant EDC database and transcription) to meet the standards for regulatory submission.

We also offer support for traditional online surveys among consumers, healthcare providers and others, and have extensive experience with questionnaire design.

Self-Selection Testing

Self-selection tests are different than early label development and comprehension studies because they target consumers who have the condition or indication the medication treats. However, the same tools listed above can be deployed for remote selection testing:

• Social media/digital advertising to target specific indications and conditions
• Targeted recruitment campaigns with partnering PBMs and health insurance providers
• Telephone (or online audio/video interface) for data collection

Fully-Remote “Real World Evidence” and Actual Use Studies

PEGUS is currently conducting a fully-remote, prospective RWE study (in patients with current prescriptions) to provide real-world comparisons to support an OTC-switch NDA. This innovative study uses procedures that mirror a typical OTC actual use study, except there are no traditional brick-and-mortar sites and all recruiting, screening, enrollment and assessments are carried out by PEGUS from a distance. This study type can be readily deployed in the current “lock-down” environment across a variety of indications.

The same tools can also apply directly to remote actual use studies. These are methods we are already using at PEGUS right now:

• Online consumer self-screening and self-scheduling
• Fully-remote, interviewer-mediated study enrollment by telephone
• Remote REALM (word list displayed from proprietary on-line URL)
• eConsent and eDiary functionality
• Periodic follow-up telephone interviews with participants by our team of registered nurses. These explore reasons for use and misuse patterns (observed from the eDiary), safety and other key outcome measures.

In addition, we have developed methodology to rapidly deliver investigational product directly to study participants from regional depots via courier. That step will enable full deployment of OTC AUSs from a distance.

While COVID-19 restrictions make remote data collection highly attractive, even under “normal” conditions there are many benefits from using these same methods to conduct consumer behavior studies, including rapid deployment, reduced costs and potentially broader sampling.

If any of these innovative methods for remote consumer behavior research fit your unique program needs, please contact us at 801-990-6126 or email clark@pegus.com.