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Sample Size for Phase II | Simon’s Two-Stage Design and MCP-Mod

October 18, 2019

About the webinar

In this webinar, we cover how to design and find the appropriate sample size for two common Phase II methods: Simon’s Two-Stage Design and MCP-Mod.

Sample Size for Phase II Clinical Trials


Phase II clinical trials are usually the first opportunity to investigate the efficacy of a new treatment in human subjects. Phase II trials provide valuable insights into the potential efficacy and the potential optimal dose for a proposed drug and the information gathered is increasingly used directly in Phase III trials.

However, Phase II is also the most common step at which treatment fails to show sufficient promise and thus good study design is vital to ensure this decision is made properly. Despite this statistical methods have been relatively underdeveloped but the acceptance from the FDA & EMA of recent statistical innovations such as MCP-Mod provides a greater chance to make phase II studies more effective and help make better phase III trials.

Simon's Two-Stage Design | Case Study

The Simon's two-stage design is one of the most commonly used phase II designs as it controls the Type I and II error while being optimal terms of the expected sample size being minimized if the regimen has low activity under the null hypothesis.

This webinar explains the theory behind Simon’s Two-Stage Design and how to plan the study using this design using a practical example.

MCP-Mod | Case Study

MCP-Mod (Multiple Comparisons & Modelling) is an increasingly popular statistical methodology for model-based design and analysis of dose-finding studies in Phase IIb trials. Its strength lies in providing flexibility in characterizing the expected dose-response curve by allowing multiple models to be evaluated at the same time while still giving results which are efficient and control the error rates.

Since its development at Novartis, MCP-Mod promises to devise proof-of-concept and dose-ranging trials which generate superior statistical evidence for dose-selection, while providing safety and efficacy data that can prove critical data for Phase III clinical trial design.

This webinar explains the theory behind MCP-Mod and how to plan a study using this method using a practical example.

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Duration: 60 minutes 
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If you don't have time to watch the webinar, you can read more about MCP-Mod, in a recent blog post MCP-Mod (Multiple Comparisons - Modelling) Explained

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