Areas of Research Expertise

CSURES

Areas of Research Expertise

CSUR staff have designed and executed regulatory related behavioural science studies for many of the largest manufacturers within the tobacco harm reduction ENDS space. This includes undertaking studies on both current ENDS products and future ENDS products assessing such areas as:

Prevalence of use and intentions to use diverse ENDS products amongst different population groups

Research on the appeal of diverse ENDS to different population groups e.g. current, former, and never smokers, adults, and young people.

Research on the harm perceptions and reasons for ENDS product use.

Research on the nature and extent of adverse events associated with ENDS use.

Research on consumer pathways following ENDS use.

Research on the differential rate and sustainability of switching from combustible tobacco products to ENDS use.

Research on the role of flavours in adult smokers switching behaviour.

Research into the reasons why some smokers choose to not use ENDS products despite their lower likely harm profile.

Regulatory Contacts

CSUR staff have experience of liaising directly with a range of regulatory bodies, including FDA, to ensure that where studies are being conducted as part of a regulatory submission that the research meets the needs of the regulatory bodies involved.

Flagship Study: Comparative Assessment of Real-World ENDS use (The Big Vape Survey UK)

The world of ENDS research has been largely divided between those studies that have focussed on assessing the public health impact of ENDS as a category and those which, as a result of regulatory requirements, have focussed on assessing the health impact of individual devices/fluids/nicotine strengths. What has been missing in this are studies assessing the relative impact of different brands and types of ENDS devices. In 2021 CSUR will undertake research assessing 9 of the top ENDS devices on sale in the U.K. comparing the relative rates with which  these devices are enabling adult smokers in the US and U.K. to quit and reduce their cigarette consumption. This study of real-world ENDS users will be repeated on an annual basis. 

Flagship Study: ENDS Prevalence

This month CSUR will launch new research built to estimate the prevalence and patterns of use of 20 ENDS brands and over 200 ENDS devices sold in the United States. This research is designed to provide ENDS manufacturers with population-level use data on their products for submission to FDA in seeking PMTA approval.

Data collected can be submitted as an amendment to filed applications that have not yet entered the substantial scientific review phase, to address any deficiencies related to behavioural or population-level use data identified by FDA or make up part of the post market surveillance for a product that has received a marketing order.
 

Extent and reasons for dual use of ENDS and combustible tobacco products.

CSURES staff have experience of liaising with FDA regulatory authorities with regard to the optimal design of research studies aiming to collect behavioral data suitable for PMTA/MRTP regulatory submissions.

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