Behavioral Studies

Understanding the impact your product has on human behavior

Behavioral Studies

Behavioral assessment of your product is one of the most important datasets generated to support your NGP, especially when utilizing the PMTA and MRTPA pathways. The recent surge in NGP (E-cigarettes) popularity globally, indicates the massive potential these products have to off-ramp smokers from combustible cigarettes. However, it also highlights a dark side that all manufacturers must take very seriously. At the end of 2019, the US was faced with a grave situation whereby a large number of underaged (younger than 18) youth who had previously not smoked or used nicotine containing products, started using e-cigarettes, creating a new generation of users dependant on nicotine.

Behavioral studies are large, online nationally representative surveys across different cohorts and age-groups designed to demonstrate if your NGP, the associated product presentation, and marketing are attractive to youth. Youth appeal could result in significant youth uptake thereby negating the potential beneficial effects your products may have amongst smokers in the US. The ability to demonstrate that your product is unlikely to result in youth use is an extremely important element when FDA considers if your NGP is Appropriate for the Protection of the Public Health (APPH). Essentially, APPH is a balance of the benefit to current smokers (off-ramping from combustible cigarettes) and the negative population health impact of introducing a new generation of youth addicted to nicotine through introduction of your NGP (on-ramping to nicotine).

There are three types of behavioral studies that are conducted to support a PMTA/MRTP:

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Perception of Risk

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Intention to Use

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Prevalence of Use studies

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Regulatory Submission

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Prevalence of Use Studies

Perception of Risk

Surveys to determine, across different nationally representative cohorts, what the risk perception of the NGP is compared to cigarettes and other products within the NGP category.

Intention to Use

Surveys to determine, across different nationally representative cohorts, what the intention to use the NGP is if the product was marketed in the USA.

Prevalence of Use Studies

Once the product is marketed, as part of the on-going post-market surveillance, gaining an understanding of who is using the NGP and why.

Human Factor Studies

Human factor studies consist of small panels and simulated product use. These studies are designed to determine if users can use your product correctly, as per the instruction manual, thereby reducing the possibility of product misuse. These studies prove that your instructions can be followed easily, ensuring that the product is used as intended. They also ensure that product performance and therefore the APPH status of the product can be maintained.

Our team of behavioral consultants have designed, executed and interpreted data from these types of studies across a wide range of NGPs. With Broughton, you can be sure that you will get the latest and most trusted advice on the design of these studies and importantly, what the results mean for your NGPs.

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