New Method to Estimate Impact of FDA Tobacco Regulations - School of Public Health

Joe Koopmeiners smiling — Associate Professor Joseph Koopmeiners

A continuing high priority for the U.S. public health community is reducing the smoking of combustible tobacco products across the nation. Currently, the FDA Center for Tobacco Products is considering a number of potential tobacco product regulations — most notably a reduction in the nicotine content of cigarettes to non-addictive levels — to curb the impact of smoking on public health. However, it can be difficult to estimate the impact of potential regulations on the entire U.S. population using data collected from randomized clinical trials. To make it easier, researchers with the University of Minnesota School of Public Health are developing statistical methods to estimate the impact of tobacco product regulations.

Led by Associate Professor Joseph Koopmeiners and Assistant Professor David Vock, the Minnesota researchers will develop and test their methods by analyzing the results of multiple nicotine reduction regulation studies on the U.S. population.

David Vock smiling — Assistant Professor David Vock

“Our study represents a significant contribution to the field of tobacco regulatory science through the development of innovative statistical methods that will result in more precise estimates of the impact of potential FDA regulatory action,” says Koopmeiners.

Koopmeiners and Vock will apply their methodology to data from 12 randomized trials of reduced nicotine content cigarettes with a total of 5,000 participants to evaluate the impact of nicotine reduction as a regulatory policy.

The study has three specific aims:

Aim 1: Develop statistical methods to more efficiently estimate causal effects by combining data from multiple studies.
Aim 2: Develop a robust approach for estimating causal effects in vulnerable populations.
Aim 3: Develop methods to calibrate causal effects to a relevant target population.

The study is funded by the National Institutes of Health and Food and Drug Administration Center for Tobacco Products. Together, Koopmeiners and Vock are the only statisticians leading a project funded by the National Institutes of Health and the FDA Center for Tobacco Products.