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MCP-Mod | Optimizing Phase II Dose Selection

November 23, 2020

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

Mcp-mod-optimizing-phase-ii-dose-selection-for-continuous-and-non-continuous-endpoints-playback

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

Play the video below to watch
the complete recording of this webinar

Duration: 60 minutes 
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If you are looking more information on MCP-MOD, check out our full guide here:

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