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.
Speaker: Ronan Fitzpatrick, Head of Statistics, Statsols
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