The Cytel blog keeps you up to speed with the latest developments in biostatistics and clinical biometrics.
Its important to take a strategic approach to clinical development in order to minimize the potential for Phase 3 attrition. The below infographic, previously published on the blog highlights some of the approvability and economic reasons cited for Phase 3 failure , and the clinical development issues which may have had an impact.
At a recent PhUSE SDE, Cytel’s Chitra Tirodkar presented how East PROC MCPMod could be used to help solve the problem of uncertain true dose-response relationship in a bronchodilator study. In this blog we summarize some of the issues, and make Chitra's slides available for download.
MCP-Mod methodology for dose-ranging clinical trials has been gaining popularity since the 2013 publication of the qualification opinion by the European Medicines Agency Committee for Medical Products for Human Use. 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.
Although the general framework of the MCP-Mod method are becoming more familiar, its added complexity raises the question of whether it is a necessary supplement (or even substitute) for traditional dose-ranging trials. Here are a few shortfalls of the traditional approach that MCP-Mod is equipped to handle.