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.
Sophie Sun
Novartis
Rshiny app on Ph2b trial design based on MCP-Mod
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.