American Statistical Association
New York City
Metropolitan Area Chapter

Memorial Sloan Kettering Cancer Center
Department of Epidemiology and Biostatistics
Biostatistics Seminar Series


Joseph Koopmeiners, Ph.D.
Interim Head, Division of Biostatistics
University of Minnesota

THE ROLE OF STATISTICAL METHODS RESEARCH
IN TOBACCO REGULATORY SCIENCE

The 2009 Family Smoking Prevention and Tobacco Control Act gave the Food and Drug Administration (FDA) the authority to regulate the manufacturing, marketing, and distribution of tobacco products. A key component of this law is that the FDA can set new tobacco product standards if it will improve the public health. Arguably the most widely debated and impactful standard would address the addictiveness of cigarettes and other combusted tobacco products by reducing their nicotine content to non-addictive levels. Over the last decade, the FDA and National Institutes of Health have funded numerous randomized controlled trials intended to evaluate the impact of reducing the nicotine content of cigarettes. These trials have yielded promising results, demonstrating that smokers randomized to low nicotine content cigarettes report smoking fewer cigarettes per day and have reduced exposure to toxicants, but also posed a number of statistical challenges that required novel methods to answer the questions that are most relevant to the FDA Center for Tobacco Products. In this talk, I describe a sequence of methodological developments motivated by my experience with regulatory tobacco clinical trials, focusing primarily on methods to detect and account for non-compliance in these trials, highlighting the crucial role of statistical methods research in understanding nicotine reduction as a potential regulatory policy. Finally, I will conclude by providing an overview of ongoing research in this area related to understanding heterogeneity in the effect of nicotine reduction.


Date: Wednesday, May 15, 2019
Time: 4:00 - 5:00 P.M.
Location: Memorial Sloan Kettering Cancer Center
Department of Epidemiology and Biostatistics
485 Lexington Avenue
(Between 46th & 47th Streets)
2nd Floor, Conference Room B
New York, New York

**Outside visitors please email koppenar@mskcc.org for building access. You must be on the security list to enter the floor.

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