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The objective of population modeling is to study the impact of tobacco products on the population as whole. Input parameters include demographic information, tobacco use transition probability and mortality and/or morbidity. The input parameters are typically derived from population-level sources (e.g., census data or other population-level surveys). However, depending on the objective, other sources of data may be used. When using these other sources, steps should be taken to ensure they are representative of the population.
Outputs of the model may include projections on morbidity/mortality and prevalence of use resulting from the impact of the desired objective of the model (such as new product authorizations or regulatory policy development).

In this section, these models are discussed with regard to inputs to, and outputs from the models, and how these models contribute to studies of tobacco products, and how they are represented in CDISC standards for submission to a regulatory authority.

For example, the use of System dynamic modeling (SDM) in tobacco research and regulation has a long history with models developed to study different aspects of the tobacco landscape via population dynamics. In the early 2000’s, SDMs were developed in which the dynamic of the population was projected based on a system of difference equations (discrete time). Those early models – involving a small number of compartments – were developed to investigate the impact of user behaviors (initiation, cessation, relapse) of a single tobacco product (such as cigarettes) on prevalence and mortality. Research and regulatory activities at CTP have opened the door to a new class of models in which it is fundamental to account for the impact of multiple tobacco products on the dynamic of the population in relation to user behaviors – including poly-user – and health outcomes known to be causally related to the use of tobacco products, including mortality. For example, it is important to understand how potential behavioral responses to the introduction of a new MR product (e.g., initiation, switching from cigarettes, dual use) will impact use patterns and tobacco-related disease and mortality.

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