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TSRC, Tob. Sci. Res. Conf., 2022, 75, abstr. 112

Statistically optimizing youth risk and smoking cessation: a novel, data-driven approach to evaluate appropriateness for the protection of public health

SELTZER R.(1); PARKER-ZDINAK J.(2); FEARON I.M.(3)
(1) Safety in Numbers, Tucson, AZ, USA; (2) Applied Research and Analysis Consulting, Richmond, VA, USA; (3) whatIF? Consulting, Harwell, UK

Behavioral surveys for Premarket Tobacco Product Applications (PMTAs) for novel non-combustible tobacco products are intended to show that the benefits to smoking cessation outweigh the risks of youth initiation and use among nicotine non-users. The balancing of risk and benefit is typically done through researchers’ subjective interpretation of trends or descriptive summaries of survey responses. The lack of standardized, objective assessment, however, can potentially bias conclusions. Furthermore, inferential statistical techniques are often used to show significant benefit to cessation or to show significant youth use risk, but they rarely simultaneously weigh the youth risk with the cessation benefit of a novel product in a single statistical model. In addition to methodological limitations, there is little specific guidance from regulatory agencies on which numbers, thresholds, or trends are favorable for an optimal risk-benefit balance. An analytic method to objectively and simultaneously balance the youth use risk with the smoking cessation benefit is proposed and demonstrated with real data from the PATH database. These demonstrations comprise simulated examples where cessation outweighs risk and vice versa. This method first quantifies relationships between behavioral survey responses concerning odds of cessation and youth use, and then enters these values into optimization algorithms. The results of this analysis are intended to determine the risk-benefit ratio of a particular novel tobacco product and reveal what factors are most important in determining this ratio. Knowledge of these factors can provide direction on what areas of youth use and smoking cessation need to be addressed to improve the risk-benefit balance. This approach can help clarify what information should be collected in PMTAs and guide efforts to standardize and inform the review and regulation-setting process.