Joseph S. Koopmeiners, of the Division of Biostatistics at the University of Minnesota and candidate for the Division Head position in the Division of Biostatistics, will present:

“The Role of Statistical Methods Research in Tobacco Regulatory Science”

Abstract: 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. In the latter portion of the talk, I will provide an overview of my previous experiences in research, teaching, and service to the profession, with an emphasis on how these experiences have prepared me for the role of Head of the Division of Biostatistics.

Refreshments will be served prior to the seminar. All are welcome.