Events & Calendars Statistics and Data Science Colloquium: How Statistics Can Make an Impact: A Case Study Describing the Filing Story of ZINPLAVA

Speaker: Alison Pedley, Ph.D., Merck

Statistics plays a big role in drug development in the design and analysis of clinical trial data. This case study explores an example where statistics made a huge impact and allowed for a deeper understanding of the data. More specifically, ad-hoc sensitivity analyses designed and conducted by the statistical team proved to be critical to the product’s approval. Two large, phase 3 trials were conducted to demonstrate the superiority of ZINPLAVA over placebo. Though the primary endpoint was met in both studies, another important endpoint had conflicting results. In one study, ZINPLAVA was significantly higher, and in the other study, it was significantly lower. This talk will also give a brief overview of the drug development process and the role of a statistician at a large pharmaceutical company in clinical development.

*The link will be sent to the Math & Stats listserv on the day of the event. If you are not part of that group and would like to attend, please email kglista@amherst.edu, and the link will be sent the day of the event.