MCP-Mod | Optimizing Phase II Dose Selection

About the webinar

Through 00-12, the FDA rejected approximately 29% of first-time marketing applications of NMEs due to uncertainties related to dose selection and choice of endpoint.

For those that resubmitted, the median delay to approval was a further 435 days. In 2016, a statistical approach received approval from the FDA as a strategy to overcome these problems.

In our upcoming webinar, we will provide practical examples of how to use this approach for your dose-finding study through various endpoints..

MCP-Mod
Optimizing Phase II Dose Selection for
Continuous and Non-Continuous Endpoints

In this free webinar you will learn about:

An introduction to MCP-Mod
Why use MCP-Mod for Phase II trials
Steps to generate superior statistical evidence for dose-selection
MCP-Mod for various endpoints, including:
- Continuous Endpoint
- Binary Endpoint
- Poisson Rates
- Negative Binomial rates
Worked examples & case studies

Speaker: Brian Fox, Research Statistician, Statsols