Abstract: Finding the right dose is a critical step in pharmaceutical drug development. There has been varies statistical methodology development for the design and analysis of clinical studies. In particular, MCP-Mod (Multiple Comparisons Procedure - Modelling) has gain increasing popularity and has received wide recognition from the regulatory agencies (e.g., EMA in 2014 and FDA in 2016) on the design and analysis for Phase 2 studies. Based on the methodology, R package, DoseFinding, provides functions for both design and analysis of dose-finding experiments. Novartis has conducted a survey of how to help the associate to easily access the tools to use MCP-Mod for the design of Phase 2b study. As a result, a Rshiny app is developed focus on the design of Phase 2b study based on MCP-Mod. The app handles continuous, binary and count endpoint, and allow computations based on multiple choices of study set simultaneously.
Speaker: Sophie Sun
Title: Rshiny app on Ph2b trial design based on MCP-Mod
Abstract_Sanitzed: Finding the right dose is a critical step in pharmaceutical drug development. There has been varies statistical methodology development for the design and analysis of clinical studies. In particular, MCP-Mod (Multiple Comparisons Procedure - Modelling) has gain increasing popularity and has received wide recognition from the regulatory agencies (e.g., EMA in 2014 and FDA in 2016) on the design and analysis for Phase 2 studies. Based on the methodology, R package, DoseFinding, provides functions for both design and analysis of dose-finding experiments. Novartis has conducted a survey of how to help the associate to easily access the tools to use MCP-Mod for the design of Phase 2b study. As a result, a Rshiny app is developed focus on the design of Phase 2b study based on MCP-Mod. The app handles continuous, binary and count endpoint, and allow computations based on multiple choices of study set simultaneously.