Combining Statistical and Compartmental Models for Use in Tobacco Product Risk Assessments (303261)

Keywords: Compartmental Models, Public Health, Survival Analysis, Cohort Models.

According to the Federal Food, Drug and Cosmetic Act, a Modified Risk Tobacco Products Application submitted to the Food and Drug Administration (FDA) must demonstrate that the Modified Risk Tobacco Product (MRTP) will significantly reduce the risk and harm of tobacco-related disease to the user and benefit the health of the population as a whole. In their guidance documents, FDA encourages use of mathematical and statistical models to make preliminary estimates of the potential effects of introducing an MRTP into the marketplace. We will share development and application of an approach that applies statistical models as well as deterministic compartmental models on a hypothetical cohort population. The model assesses the impact of introducing an MRTP, by estimating change in all-cause mortality from a status quo scenario following introduction of the MRTP into the hypothetical population. Statistical models combined with excess relative risks are used to determine survival probabilities. A compartmental model with well researched transition probabilities are used to propagate the cohort through the various states across time.