Tuesday, Aug 6: 9:55 AM - 10:15 AM
Invited Paper Session
Oregon Convention Center
Over the last 15+ years, the University of North Carolina Department of Biostatistics and Merck's Department of Biostatistics and Research Decision Science (BARDS) have collaborated closely on a number of important statistical research projects. These projects have resulted in significant methodological contributions to the statistical field with applications to real-world problems in pharmaceutical R&D. These cover a wide scope of research topics: from frequentists to Bayesian approaches, from trial level design to aggregate/meta analyses, and from traditional statistical modelling to machine learning methodologies. The areas of pharmaceutical applications include, just naming a few examples, safety signaling and evaluation, the efficacy evaluation of innovative medicines (eg lipid lowering therapies) and post-marketing assessment of rare but serious safety events in the Rotavirus Vaccine. Case studies will be highlighted during the presentation. This collaboration has won the 2023 SPAIG Award.