Sample size and power training for use in clinical trials


Sample Size for
Phase II Clinical Trials

Simon's Design and MCP-Mod Case Studies

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About the webinar

Sample Size for Phase II Clinical Trials:
Simon's Design and MCP-Mod Case Studies

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.

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.

In this free webinar you will learn about:

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 in terms of the expected sample size being minimized if the regimen has low activity under the null hypothesis.

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

Duration - 60 minutes

Speaker: Ronan Fitzpatrick, Head of Statistics, Statsols

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About Our Host
Ronan Fitzpatrick

Ronan Fitzpatrick Circle Image 150px
Ronan Fitzpatrick is Head of Statistics at Statsols and the Lead Researcher for nQuery Sample Size Software. He has been a guest lecturer for many institutions including the FDA. 
Reducing the risk & cost of clinical trials, for innovative organizations such as:
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