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CORESTA Meeting, Smoke Science/Product Technology, 2023, Cancun, STPOST 47

Systematic review of the design and conduct of actual use studies of new tobacco products

(1) JT International SA, Geneva, Switzerland; (2) Bajec Senseworks Consulting, Hamilton, Ontario, Canada; (3) PEGUS Research, Inc., Salt Lake City, UT, U.S.A.; (4) Russell Burnett Research & Consultancy Ltd, Glasgow, U.K.

Submission of a Premarket Tobacco Product Application (PMTA) is required for manufacturers seeking a Marketing Granted Order (MGO) from the US Food & Drug Administration (FDA) Center for Tobacco Products (CTP). PMTA assessment of the public health impact of new tobacco products (NTP) must include evidence on how adult consumers actually use the products. Actual Use Studies (AUS) have been conducted to gather information on how NTP would affect the use behavior of current tobacco users in their natural environments. Given there are no detailed formal guidance or a widely accepted methodological framework for executing NTP AUS, PMTA applicants could build upon design elements and principles of actual use trial performed in support of switching prescription (Rx) to over-the-counter (OTC) drugs. A systematic review extending back to 2010 was performed to identify NTP AUS conducted by manufacturers with the main goal of delineating key design and methodological elements between studies, and outlining design parameters specific to NTP compared to the approach generally adopted for OTC drug AUS. Included studies were those of any design that captured tobacco use behavior among adult participants using Test Products and any other tobacco products ad libitum, under real-world conditions (e.g., at home), utilizing Consumer Reported Outcome Measures (CROM) from the same participants over time. Similarities and differences of included NTP AUS records were summarized according to methodological designs (e.g., sampling frame, study phases and duration, endpoints), operational procedures (e.g., enrolment strategy, Test Products management), data capture methods (e.g., diary, recall period), and data analysis approach. NTP manufacturers have carefully tailored AUS design parameters to study objectives towards evidence generation for scientific substantiation. Novel design elements could provide further insights concerning the consumer journey, such as the role flavors may play in a fulfilling product experience, and further support regulatory engagement.