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.
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