Logistic regression is not just logistic regression: tales of statistical consulting in pharmacometrics

Presented by James A. Rogers, PhD, Vice President of Statistics, Quantitative Sciences, Metrum Research Group

DATE : Wednesday, Oct 11, 2023

TIME : 4:00 PM-5:00 PM ET

PLACE: AUST 110

“Pharmacometrics” is a term that refers somewhat broadly and vaguely to quantitative biomedical science that gives “particular attention to [safe and effective] drug dosing for all patients” [1]. While there is no definitive division between the biostatistics community and pharmacometrics community, the former places relatively more emphasis on determining whether drugs work (in aggregate), especially as informed by definitive randomized comparisons, while the latter places relatively more emphasis on why and under what conditions drugs work, and generally aspires to leverage the “totality of evidence” (integrating both randomized and non-randomized lines of evidence). Additional distinctions can be made from a regulatory perspective: within the US FDA, “biostatistical” arguments are reviewed primarily by the Office of Biostatistics, while “pharmacometric” arguments are reviewed primarily by the Division of Pharmacometrics, which sits within the Office of Clinical Pharmacology. Under ideal conditions, “biostatistical” and “pharmacometric” approaches are complementary.

The membrane between “biostatistics” and “pharmacometrics” is increasingly permeable, and scientists with statistical training have enormous potential to influence pharmacometric science. Opportunities for impact range from highly technical challenges in the development of new methodology and tools, to less technical (but no less challenging) opportunities to promote sound statistical thinking through effective statistical consulting on so-called “simple problems”. In this talk I will recount a number of the consulting challenges associated with one common type of “simple problem” in pharmacometrics: exposure-response modeling for binary adverse events.

Speaker Bio:

Jim Rogers is the Vice President of Statistics in the Quantitative Sciences Business Unit at Metrum Research Group. After receiving his doctorate in statistics from The Ohio State University in 2001, Jim worked for two years on genomic and metabonomic analyses for biotechnology companies, followed by five years at Pfizer Global Research and Development where he worked initially and as a nonclinical statistician and later as a clinical biostatistician. In 2008, Jim joined Metrum Research Group in order to work in closer collaboration with quantitative biologists and pharmacometricians. Over the course of his 15 years at MetrumRG, Jim has worked on decision informatics across a wide range of therapeutic areas and therapeutic modalities. Recurring areas of focus have included problems related to dose selection and dose optimization, as well as platform development based on disease progression models and clinical trial simulation. From a methodological perspective, Jim’s focus in recent years has centered on the role of causal inference concepts in evidence integration. Jim believes that scientists trained in statistics can revolutionize the discipline of pharmacometrics and that scientists trained in pharmacometrics can revolutionize the discipline of statistics.